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Veterans Affairs Illiana Health Care System - Form 483, 2011-05-26
$289 - Available for instant download
Issued On: May, 2011
Inspection Type: FDA 483
Site Name: Veterans Affairs Illiana Health Care System [Danville / United States of America]
Tensys Medical Inc - Form 483, 2011-05-13
$289 - Available for instant download
Issued On: May, 2011
Inspection Type: FDA 483
Site Name: Tensys Medical Inc [San Diego / United States of America]
Sparton Medical Systems Colorado - Form 483, 2011-04-15
$289 - Available for instant download
Issued On: April, 2011
Inspection Type: FDA 483
Site Name: Sparton Medical Systems Colorado [Frederick / United States of America]
Neurowave Systems Inc - Form 483, 2011-04-04
$289 - Available for instant download
Issued On: April, 2011
Inspection Type: FDA 483
Site Name: Neurowave Systems Inc [Cleveland Heights / United States of America]
Ophthalmic Imaging Systems - Form 483, 2011-03-25
$289 - Available for instant download
Issued On: March, 2011
Inspection Type: FDA 483
Site Name: Ophthalmic Imaging Systems [Sacramento / United States of America]
Bio Compression Systems, Inc. - Form 483, 2011-03-21
$289 - Available for instant download
Issued On: March, 2011
Inspection Type: FDA 483
Site Name: Bio Compression Systems, Inc. [Moonachie / United States of America]
ThyssenKrupp Access Corp - Form 483, 2011-03-10
$289 - Available for instant download
Issued On: March, 2011
Inspection Type: FDA 483
Site Name: ThyssenKrupp Access Corp [Grandview / United States of America]
Axon Systems Inc - Form 483, 2011-03-02
$289 - Available for instant download
Issued On: March, 2011
Inspection Type: FDA 483
Site Name: Axon Systems Inc [Hauppauge / United States of America]
Roche Insulin Delivery Systems Inc. - Form 483, 2011-02-28
$289 - Available for instant download
Issued On: February, 2011
Inspection Type: FDA 483
Site Name: Roche Insulin Delivery Systems Inc. [Fishers / United States of America]
Duke University Health System Irb - EIR, 2011-02-04
$1190 - Available for instant download
Issued On: February, 2011
Inspection Type: EIR
Site Name: Duke University Health System Irb [Durham / United States of America]
Expert Chemical Analysis, Inc. - Form 483, 2011-01-28
$289 - Available for instant download
Issued On: January, 2011
Inspection Type: FDA 483
Site Name: Expert Chemical Analysis, Inc. [San Diego / United States of America]
Nuclear Cardiology Systems, Inc. - Form 483, 2011-01-14
$289 - Available for instant download
Issued On: January, 2011
Inspection Type: FDA 483
Site Name: Nuclear Cardiology Systems, Inc. [Boulder / United States of America]
American Contract Systems Inc - Form 483, 2011-01-14
$289 - Available for instant download
Issued On: January, 2011
Inspection Type: FDA 483
Site Name: American Contract Systems Inc [Tiffin / United States of America]
Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. - Form 483, 2010-12-17
$289 - Available for instant download
Issued On: December, 2010
Inspection Type: FDA 483
Site Name: Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. [Dover / United States of America]
Medical Laser Systems Inc - Form 483, 2010-12-14
$289 - Available for instant download
Issued On: December, 2010
Inspection Type: FDA 483
Site Name: Medical Laser Systems Inc [Branford / United States of America]
Biocare Systems, Inc. - Form 483, 2010-12-03
$289 - Available for instant download
Issued On: December, 2010
Inspection Type: FDA 483
Site Name: Biocare Systems, Inc. [Parker / United States of America]
Philips Medical Systems (Cleveland) Inc - Form 483, 2010-12-03
$289 - Available for instant download
Issued On: December, 2010
Inspection Type: FDA 483
Site Name: Philips Medical Systems (Cleveland) Inc [Cleveland / United States of America]
ZACH SYSTEM S.A. - EIR, 2010-12-02
$1190 - Available for instant download
Issued On: December, 2010
Inspection Type: EIR
Site Name: ZACH SYSTEM S.A. [France / France]
UROMATRIX Medical Systems (A Pos-T-Vac Medical Company) - Form 483, 2010-12-02
$289 - Available for instant download
Issued On: December, 2010
Inspection Type: FDA 483
Site Name: UROMATRIX Medical Systems (A Pos-T-Vac Medical Company) [Martinez / United States of America]
Lystn LLC - EIR, 2010-12-01
$1190 - Available for instant download
Issued On: December, 2010
Inspection Type: EIR
LTS Lohmann Therapy Systems Corp. - Form 483, 2010-11-17
$289 - Available for instant download
Issued On: November, 2010
Inspection Type: FDA 483
Site Name: LTS Lohmann Therapy Systems Corp. [Jersey / United States of America]
Thermal Therapeutic Systems, Inc. % Pittsburgh Life Sciences - Form 483, 2010-11-10
$289 - Available for instant download
Issued On: November, 2010
Inspection Type: FDA 483
Site Name: Thermal Therapeutic Systems, Inc. % Pittsburgh Life Sciences [Pittsburgh / United States of America]
DeJarnette Research Systems, Inc. - Form 483, 2010-11-03
$289 - Available for instant download
Issued On: November, 2010
Inspection Type: FDA 483
Site Name: DeJarnette Research Systems, Inc. [Towson / United States of America]
Enthermics Medical Systems, Inc. - Form 483, 2010-11-01
$289 - Available for instant download
Issued On: November, 2010
Inspection Type: FDA 483
Site Name: Enthermics Medical Systems, Inc. [Menomonee Falls / United States of America]
Mercator Medsystems, Inc. - EIR, 2010-10-28
$1190 - Available for instant download
Issued On: October, 2010
Inspection Type: EIR
Site Name: Mercator Medsystems, Inc. [Emeryville / United States of America]
Promega Biosystems Sunnyvale, Inc. - Form 483, 2010-10-08
$289 - Available for instant download
Issued On: October, 2010
Inspection Type: FDA 483
Site Name: Promega Biosystems Sunnyvale, Inc. [Sunnyvale / United States of America]
Gendex Dental Systems - Form 483, 2010-10-08
$289 - Available for instant download
Issued On: October, 2010
Inspection Type: FDA 483
Site Name: Gendex Dental Systems [Des Plaines / United States of America]
Chembio Diagnostic Systems, Inc - EIR, 2010-10-01
$1190 - Available for instant download
Issued On: October, 2010
Inspection Type: EIR
Site Name: Chembio Diagnostic Systems, Inc [Medford / United States of America]
Merit Medical Systems, Inc. - Form 483, 2010-09-02
$289 - Available for instant download
Issued On: September, 2010
Inspection Type: FDA 483
Site Name: Merit Medical Systems, Inc. [Chester / United States of America]
Dream Systems, LLC - Form 483, 2010-07-27
$289 - Available for instant download
Issued On: July, 2010
Inspection Type: FDA 483
Site Name: Dream Systems, LLC [Roseville / United States of America]
CoolSystems, Inc. DBA Game Ready - Form 483, 2010-07-01
$289 - Available for instant download
Issued On: July, 2010
Inspection Type: FDA 483
Site Name: CoolSystems, Inc. DBA Game Ready [Concord / United States of America]
Packaging Systems, LLC - Form 483, 2010-06-23
$289 - Available for instant download
Issued On: June, 2010
Inspection Type: FDA 483
Site Name: Packaging Systems, LLC [Keasbey / United States of America]
Philips Medical Systems - Form 483, 2010-06-14
$289 - Available for instant download
Issued On: June, 2010
Inspection Type: FDA 483
Site Name: Philips Medical Systems [Cleveland / United States of America]
Medro Systems, Inc - Form 483, 2010-06-04
$289 - Available for instant download
Issued On: June, 2010
Inspection Type: FDA 483
Site Name: Medro Systems, Inc [Mckinney / United States of America]
Lauryssen, Carl - EIR, 2010-05-26
$1190 - Available for instant download
Issued On: May, 2010
Inspection Type: EIR
Site Name: Lauryssen, Carl [Austin / United States of America]
Lauryssen, Carl - Form 483R, 2010-06-04
$289 - Available for instant download
Issued On: May, 2010
Inspection Type: FDA 483 Response
Site Name: Lauryssen, Carl [Austin / United States of America]
Blackrock Microsystems, LLC - Form 483, 2010-05-14
$289 - Available for instant download
Issued On: May, 2010
Inspection Type: FDA 483
Site Name: Blackrock Microsystems, LLC [Salt Lake City / United States of America]
GE Healthcare Inc. (Medi-Physics, Inc. dba GE Healthcare) - Form 483, 2010-04-08
$289 - Available for instant download
Issued On: April, 2010
Inspection Type: FDA 483
Terumo Cardiovascular Systems Corporation - Form 483, 2010-03-29
$289 - Available for instant download
Issued On: March, 2010
Inspection Type: FDA 483
Site Name: Terumo Cardiovascular Systems Corporation [Ann Arbor / United States of America]
Non-Invasive Monitoring Systems, Inc. - Form 483, 2010-03-25
$289 - Available for instant download
Issued On: March, 2010
Inspection Type: FDA 483
Site Name: Non-Invasive Monitoring Systems, Inc. [Miami / United States of America]
Memorial Health Care System Institutional Review Board - Form 483, 2010-03-12
$289 - Available for instant download
Issued On: March, 2010
Inspection Type: FDA 483
Site Name: Memorial Health Care System Institutional Review Board [Chattanooga / United States of America]
Nortech Systems, Inc. - Form 483, 2010-03-04
$289 - Available for instant download
Issued On: March, 2010
Inspection Type: FDA 483
Site Name: Nortech Systems, Inc. [Milaca / United States of America]
Diopsys, Inc. - Form 483, 2010-03-01
$289 - Available for instant download
Issued On: March, 2010
Inspection Type: FDA 483
Site Name: Diopsys, Inc. [Pine Brook / United States of America]
General Physiotherapy Inc - Form 483, 2010-02-22
$289 - Available for instant download
Issued On: February, 2010
Inspection Type: FDA 483
Site Name: General Physiotherapy Inc [Earth City / United States of America]
Hitachi Medical Systems America Inc - Form 483, 2010-02-01
$289 - Available for instant download
Issued On: February, 2010
Inspection Type: FDA 483
Site Name: Hitachi Medical Systems America Inc [Twinsburg / United States of America]
Trident Health System Irb - Form 483R, 2010-02-02
$289 - Available for instant download
Issued On: January, 2010
Inspection Type: FDA 483 Response
Site Name: Trident Health System Irb [Charleston / United States of America]
Arteriocyte Medical Systems Inc - Form 483, 2010-01-25
$289 - Available for instant download
Issued On: January, 2010
Inspection Type: FDA 483
Site Name: Arteriocyte Medical Systems Inc [Hopkinton / United States of America]
Trident Health System Irb - Form 483, 2010-01-25
$289 - Available for instant download
Issued On: January, 2010
Inspection Type: FDA 483
Site Name: Trident Health System Irb [Charleston / United States of America]
Trident Health System Irb - EIR, 2010-01-25
$1190 - Available for instant download
Issued On: January, 2010
Inspection Type: EIR
Site Name: Trident Health System Irb [Charleston / United States of America]
Internal Fixation Systems, Inc. - Form 483, 2010-01-13
$289 - Available for instant download
Issued On: January, 2010
Inspection Type: FDA 483
Site Name: Internal Fixation Systems, Inc. [Miami / United States of America]
Physio-Control, Inc. - Form 483, 2010-01-05
$289 - Available for instant download
Issued On: January, 2010
Inspection Type: FDA 483
Site Name: Physio-Control, Inc. [Redmond / United States of America]
Montgomery County Chapter Nysarc, Inc dba Liberty Enterprises - EIR, 2009-12-15
$1190 - Available for instant download
Issued On: December, 2009
Inspection Type: EIR
Site Name: Montgomery County Chapter Nysarc, Inc dba Liberty Enterprises [New York / United States of America]
Montgomery County Chapter Nysarc, Inc dba Liberty Enterprises - Form 483R, 2009-12-15
$289 - Available for instant download
Issued On: December, 2009
Inspection Type: FDA 483 Response
Site Name: Montgomery County Chapter Nysarc, Inc dba Liberty Enterprises [New York / United States of America]
Aveva Drug Delivery Systems Inc. - Form 483, 2009-12-04
$289 - Available for instant download
Issued On: December, 2009
Inspection Type: FDA 483
Site Name: Aveva Drug Delivery Systems Inc. [Florida / United States of America]
Merit Medical Systems, Inc. - Form 483, 2009-12-04
$289 - Available for instant download
Issued On: December, 2009
Inspection Type: FDA 483
Site Name: Merit Medical Systems, Inc. [South Jordan / United States of America]
Sysmex America, Inc. - Form 483, 2009-10-28
$289 - Available for instant download
Issued On: October, 2009
Inspection Type: FDA 483
Site Name: Sysmex America, Inc. [Mundelein / United States of America]
Roche Molecular Systems, Inc. - Form 483, 2009-10-21
$289 - Available for instant download
Issued On: October, 2009
Inspection Type: FDA 483
Site Name: Roche Molecular Systems, Inc. [S Branchburg / United States of America]
Applied Ozone Systems - Form 483, 2009-10-09
$289 - Available for instant download
Issued On: October, 2009
Inspection Type: FDA 483
Site Name: Applied Ozone Systems [Auburn / United States of America]
Merit Medical Systems Inc - Form 483, 2009-09-25
$289 - Available for instant download
Issued On: September, 2009
Inspection Type: FDA 483
Site Name: Merit Medical Systems Inc [Malvern / United States of America]
Vicon Motion Systems, Inc. - Form 483, 2009-10-15
$289 - Available for instant download
Issued On: September, 2009
Inspection Type: FDA 483
Site Name: Vicon Motion Systems, Inc. [Centennial / United States of America]
Angiodynamics Inc. (Navilyst Medical Inc.) - Form 483, 2009-09-21
$289 - Available for instant download
Issued On: September, 2009
Inspection Type: FDA 483
Site Name: Angiodynamics Inc. (Navilyst Medical Inc.) [Glens Falls / United States of America]
American Contract Systems, Inc. - Form 483, 2009-09-14
$289 - Available for instant download
Issued On: September, 2009
Inspection Type: FDA 483
Site Name: American Contract Systems, Inc. [Waunakee / United States of America]
King Systems Corp. dba Ambu, Inc. - Form 483, 2009-09-04
$289 - Available for instant download
Issued On: September, 2009
Inspection Type: FDA 483
Site Name: King Systems Corp. dba Ambu, Inc. [Noblesville / United States of America]
Criticare Systems, Inc. through Water Tower Capital, LLC - Form 483, 2009-08-31
$289 - Available for instant download
Issued On: August, 2009
Inspection Type: FDA 483
Site Name: Criticare Systems, Inc. through Water Tower Capital, LLC [Waukesha / United States of America]
American Contract Systems, Inc. - Form 483, 2009-08-27
$289 - Available for instant download
Issued On: August, 2009
Inspection Type: FDA 483
Site Name: American Contract Systems, Inc. [Kansas City / United States of America]
SMT Health Systems, Inc. - Form 483, 2009-08-19
$289 - Available for instant download
Issued On: August, 2009
Inspection Type: FDA 483
Site Name: SMT Health Systems, Inc. [Detroit Lakes / United States of America]
Bard Access Systems, Inc. - Form 483, 2009-08-14
$289 - Available for instant download
Issued On: August, 2009
Inspection Type: FDA 483
Site Name: Bard Access Systems, Inc. [Salt Lake City / United States of America]
Hitachi Medical Systems America Inc - Form 483, 2009-08-04
$289 - Available for instant download
Issued On: August, 2009
Inspection Type: FDA 483
Site Name: Hitachi Medical Systems America Inc [Twinsburg / United States of America]
Transtracheal Systems, Inc. - Form 483, 2009-07-31
$289 - Available for instant download
Issued On: July, 2009
Inspection Type: FDA 483
Site Name: Transtracheal Systems, Inc. [Englewood / United States of America]
GE Medical Systems Information Technologies - Form 483, 2009-07-20
$289 - Available for instant download
Issued On: July, 2009
Inspection Type: FDA 483
Site Name: GE Medical Systems Information Technologies [El Paso / United States of America]
Draeger Medical Systems, Inc. - Form 483, 2009-07-09
$289 - Available for instant download
Issued On: July, 2009
Inspection Type: FDA 483
Site Name: Draeger Medical Systems, Inc. [Telford / United States of America]
Keystone Laboratories, Inc. - Form 483, 2009-07-01
$289 - Available for instant download
Issued On: July, 2009
Inspection Type: FDA 483
Site Name: Keystone Laboratories, Inc. [Memphis / United States of America]
Promega Biosystems Sunnyvale, Inc. - Form 483, 2009-06-29
$289 - Available for instant download
Issued On: June, 2009
Inspection Type: FDA 483
Site Name: Promega Biosystems Sunnyvale, Inc. [Sunnyvale / United States of America]
LTS Lohmann Therapie-Systeme AG - EIR, 2009-06-18
$1190 - Available for instant download
Issued On: June, 2009
Inspection Type: EIR
Site Name: LTS Lohmann Therapie-Systeme AG [Andernach / Germany]
Alltech Medical Systems America Inc - Form 483, 2009-06-17
$289 - Available for instant download
Issued On: June, 2009
Inspection Type: FDA 483
Site Name: Alltech Medical Systems America Inc [Solon / United States of America]
Lifeline Systems Company - Form 483, 2009-06-11
$289 - Available for instant download
Issued On: June, 2009
Inspection Type: FDA 483
Site Name: Lifeline Systems Company [Framingham / United States of America]
Cbr Systems Inc - Form 483R, 2009-07-09
$289 - Available for instant download
Issued On: June, 2009
Inspection Type: FDA 483 Response
Site Name: Cbr Systems Inc [Tucson / United States of America]
Cbr Systems Inc - Form 483, 2009-06-03
$289 - Available for instant download
Issued On: June, 2009
Inspection Type: FDA 483
Site Name: Cbr Systems Inc [Tucson / United States of America]
Advanced Imaging Research Inc, DBA Sree Medical Systems - Form 483, 2009-06-02
$289 - Available for instant download
Issued On: June, 2009
Inspection Type: FDA 483
Site Name: Advanced Imaging Research Inc, DBA Sree Medical Systems [Cleveland / United States of America]
Custom Industrial Analysis Laboratories - Form 483, 2009-05-22
$289 - Available for instant download
Issued On: May, 2009
Inspection Type: FDA 483
Site Name: Custom Industrial Analysis Laboratories [Saint Joseph / United States of America]
Micro Typing Systems, Inc. - Form 483, 2009-05-15
$289 - Available for instant download
Issued On: May, 2009
Inspection Type: FDA 483
Site Name: Micro Typing Systems, Inc. [Pompano Beach / United States of America]
X Spine Systems Inc - Form 483, 2009-05-07
$289 - Available for instant download
Issued On: May, 2009
Inspection Type: FDA 483
Site Name: X Spine Systems Inc [Miamisburg / United States of America]
LTS Lohmann Therapy Systems Corp. - Form 483, 2009-04-27
$289 - Available for instant download
Issued On: April, 2009
Inspection Type: FDA 483
Site Name: LTS Lohmann Therapy Systems Corp. [Jersey / United States of America]
LTS Lohmann Therapy Systems Corp. - EIR, 2009-04-27
$1190 - Available for instant download
Issued On: April, 2009
Inspection Type: EIR
Site Name: LTS Lohmann Therapy Systems Corp. [Jersey / United States of America]
Poly Packaging Systems Inc. - Form 483, 2009-04-16
$289 - Available for instant download
Issued On: April, 2009
Inspection Type: FDA 483
Site Name: Poly Packaging Systems Inc. [Amory / United States of America]
VA Northeast Ohio Healthcare System IRB - EIR, 2009-01-16
$1190 - Available for instant download
Issued On: January, 2009
Inspection Type: EIR
Site Name: VA Northeast Ohio Healthcare System IRB [Cleveland / United States of America]
Summa Health System IRB - Form 483, 2008-12-15
$289 - Available for instant download
Issued On: December, 2008
Inspection Type: FDA 483
Site Name: Summa Health System IRB [Akron / United States of America]
Philips Medical Systems (Cleveland) Inc - Form 483, 2008-10-30
$289 - Available for instant download
Issued On: October, 2008
Inspection Type: FDA 483
Site Name: Philips Medical Systems (Cleveland) Inc [Cleveland / United States of America]
Tricor Systems - Form 483, 2008-10-09
$289 - Available for instant download
Issued On: October, 2008
Inspection Type: FDA 483
Site Name: Tricor Systems [Elgin / United States of America]
Terumo Cardiovascular Systems Corporation - Form 483, 2008-08-12
$289 - Available for instant download
Issued On: August, 2008
Inspection Type: FDA 483
Site Name: Terumo Cardiovascular Systems Corporation [Ann Arbor / United States of America]
GE Healthcare Inc. (Medi-Physics, Inc. dba GE Healthcare) - Form 483, 2008-06-25
$289 - Available for instant download
Issued On: June, 2008
Inspection Type: FDA 483
Southeast Georgia Health System - Brunswick Campus - EIR, 2008-06-12
$1190 - Available for instant download
Issued On: June, 2008
Inspection Type: EIR
Site Name: Southeast Georgia Health System - Brunswick Campus [Brunswick / United States of America]
X Spine Systems Inc - Form 483, 2008-04-18
$289 - Available for instant download
Issued On: April, 2008
Inspection Type: FDA 483
Site Name: X Spine Systems Inc [Miamisburg / United States of America]
Keystone Food Products, Inc. - EIR, 2008-03-07
$1190 - Available for instant download
Issued On: March, 2008
Inspection Type: EIR
Site Name: Keystone Food Products, Inc. [Easton / United States of America]
Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc. - Form 483, 2008-04-03
$289 - Available for instant download
Issued On: March, 2008
Inspection Type: FDA 483
Site Name: Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc. [Whitestown / United States of America]
LTS Lohmann Therapy Systems Corp. - EIR, 2007-11-29
$1190 - Available for instant download
Issued On: November, 2007
Inspection Type: EIR
Site Name: LTS Lohmann Therapy Systems Corp. [Jersey / United States of America]
LTS Lohmann Therapy Systems Corp. - Form 483, 2007-11-29
$289 - Available for instant download
Issued On: November, 2007
Inspection Type: FDA 483
Site Name: LTS Lohmann Therapy Systems Corp. [Jersey / United States of America]
VA GLA Health Care System (WLA) 113 - EIR, 2007-11-14
$1190 - Available for instant download
Issued On: November, 2007
Inspection Type: EIR
Site Name: VA GLA Health Care System (WLA) 113 [Los Angeles / United States of America]
Philips Medical Systems (Cleveland) Inc - Form 483, 2007-12-18
$289 - Available for instant download
Issued On: November, 2007
Inspection Type: FDA 483
Site Name: Philips Medical Systems (Cleveland) Inc [Cleveland / United States of America]
Bayscience Formulators, LLC - Form 483, 2007-11-06
$289 - Available for instant download
Issued On: November, 2007
Inspection Type: FDA 483
Site Name: Bayscience Formulators, LLC [Dudley / United States of America]