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Ponce Medical School Foundation, Inc. IRB - Form 483, 2023-02-24
$289 - Available for instant download
Issued On: February, 2023
Inspection Type: FDA 483
Site Name: Ponce Medical School Foundation, Inc. IRB [St. Ponce / United States of America]
Pausch Medical GmbH - Form 483, 2023-02-24
$289 - Available for instant download
Issued On: February, 2023
Inspection Type: FDA 483
Site Name: Pausch Medical GmbH [Erlangen / Germany]
Veran Medical Technologies Inc - Form 483, 2023-02-23
$289 - Available for instant download
Issued On: February, 2023
Inspection Type: FDA 483
Site Name: Veran Medical Technologies Inc [Saint Louis / United States of America]
AADCO Medical Inc. - Form 483, 2023-02-22
$289 - Available for instant download
Issued On: February, 2023
Inspection Type: FDA 483
Site Name: AADCO Medical Inc. [Randolph / United States of America]
Klarity Medical Products LLC - Form 483, 2023-02-16
$289 - Available for instant download
Issued On: February, 2023
Inspection Type: FDA 483
Site Name: Klarity Medical Products LLC [Heath / United States of America]
Pensar Medical LLC - Form 483, 2023-02-16
$289 - Available for instant download
Issued On: February, 2023
Inspection Type: FDA 483
Site Name: Pensar Medical LLC [Norco / United States of America]
Lions Medical Eye Bank & Research Center of Eastern VA - Form 483, 2023-02-16
$289 - Available for instant download
Issued On: February, 2023
Inspection Type: FDA 483
Site Name: Lions Medical Eye Bank & Research Center of Eastern VA [Norfolk / United States of America]
International Medication Systems, Ltd. - Form 483, 2023-02-15
$289 - Available for instant download
Issued On: February, 2023
Inspection Type: FDA 483
Site Name: International Medication Systems, Ltd. [South El Monte / United States of America]
Osteolife Biomedical I LLC - Form 483, 2023-02-14
$289 - Available for instant download
Issued On: February, 2023
Inspection Type: FDA 483
Site Name: Osteolife Biomedical I LLC [Miami / United States of America]
Biodex Medical Systems, Inc. - Form 483, 2023-02-10
$289 - Available for instant download
Issued On: February, 2023
Inspection Type: FDA 483
Site Name: Biodex Medical Systems, Inc. [Shirley / United States of America]
Outset Medical, Inc. - Form 483, 2023-02-10
$289 - Available for instant download
Issued On: February, 2023
Inspection Type: FDA 483
Site Name: Outset Medical, Inc. [San Jose / United States of America]
Engineered Medical Systems, LLC - Form 483, 2023-02-10
$289 - Available for instant download
Issued On: February, 2023
Inspection Type: FDA 483
Site Name: Engineered Medical Systems, LLC [Bartlett / United States of America]
Outset Medical, Inc. - Form 483R, 2023-02-10
$289 - Available for instant download
Issued On: February, 2023
Inspection Type: FDA 483 Response
Site Name: Outset Medical, Inc. [San Jose / United States of America]
AtlantiCare Regional Medical Center IRB - Form 483, 2023-02-23
$289 - Available for instant download
Issued On: February, 2023
Inspection Type: FDA 483
Site Name: AtlantiCare Regional Medical Center IRB [Atlantic City / United States of America]
Regional West Medical Center - Form 483, 2023-02-09
$289 - Available for instant download
Issued On: February, 2023
Inspection Type: FDA 483
Site Name: Regional West Medical Center [Scottsbluff / United States of America]
Laurel Fertility Care, A Professional Medical Corporation - Form 483, 2023-02-07
$289 - Available for instant download
Issued On: February, 2023
Inspection Type: FDA 483
Site Name: Laurel Fertility Care, A Professional Medical Corporation [San Francisco / United States of America]
Stony Brook University Medical Center - Form 483, 2023-02-07
$289 - Available for instant download
Issued On: February, 2023
Inspection Type: FDA 483
Site Name: Stony Brook University Medical Center [Stony Brook / United States of America]
UniSoft Medical Corporation - Form 483, 2023-01-19
$289 - Available for instant download
Issued On: January, 2023
Inspection Type: FDA 483
Site Name: UniSoft Medical Corporation [Torrington / United States of America]
Prestige Medical - Form 483, 2023-01-13
$289 - Available for instant download
Issued On: January, 2023
Inspection Type: FDA 483
Site Name: Prestige Medical [Northridge / United States of America]
Addivation Medical - Form 483, 2023-01-12
$289 - Available for instant download
Issued On: January, 2023
Inspection Type: FDA 483
Site Name: Addivation Medical [Chester / United States of America]
Vasomedical Inc - Form 483, 2023-01-09
$289 - Available for instant download
Issued On: January, 2023
Inspection Type: FDA 483
Site Name: Vasomedical Inc [Plainview / United States of America]
Siemens Medical Solutions USA, Inc. - Form 483, 2023-01-06
$289 - Available for instant download
Issued On: January, 2023
Inspection Type: FDA 483
Site Name: Siemens Medical Solutions USA, Inc. [Issaquah / United States of America]
MPM Medical LLC - Form 483, 2023-01-05
$289 - Available for instant download
Issued On: January, 2023
Inspection Type: FDA 483
Site Name: MPM Medical LLC [Mesquite / United States of America]
Reach Medical Inc. - Form 483, 2022-12-30
$289 - Available for instant download
Issued On: December, 2022
Inspection Type: FDA 483
Site Name: Reach Medical Inc. [Collierville / United States of America]
Lawrence Werlin MD, Inc. dba Coastal Fertility Medical Center - Form 483, 2022-12-22
$289 - Available for instant download
Issued On: December, 2022
Inspection Type: FDA 483
Site Name: Lawrence Werlin MD, Inc. dba Coastal Fertility Medical Center [Irvine / United States of America]
Advanced Research Medical, LLC - Form 483, 2022-12-20
$289 - Available for instant download
Issued On: December, 2022
Inspection Type: FDA 483
Site Name: Advanced Research Medical, LLC [Burnsville / United States of America]
Guard Medical Inc - Form 483, 2022-12-19
$289 - Available for instant download
Issued On: December, 2022
Inspection Type: FDA 483
Site Name: Guard Medical Inc [Miami / United States of America]
Siesta Medical, Inc. - Form 483, 2022-12-15
$289 - Available for instant download
Issued On: December, 2022
Inspection Type: FDA 483
Site Name: Siesta Medical, Inc. [Los Gatos / United States of America]
Acutus Medical Inc - Form 483, 2022-12-09
$289 - Available for instant download
Issued On: December, 2022
Inspection Type: FDA 483
Site Name: Acutus Medical Inc [Carlsbad / United States of America]
North American Medical Corp. (NAM) - Form 483, 2022-12-09
$289 - Available for instant download
Issued On: December, 2022
Inspection Type: FDA 483
Site Name: North American Medical Corp. (NAM) [Marietta / United States of America]
FNC MEDICAL CORPORATION - Form 483, 2022-12-09
$289 - Available for instant download
Issued On: December, 2022
Inspection Type: FDA 483
Site Name: FNC MEDICAL CORPORATION [California / United States of America]
Kensington Medical Holdings LLC - Form 483, 2022-12-07
$289 - Available for instant download
Issued On: December, 2022
Inspection Type: FDA 483
Site Name: Kensington Medical Holdings LLC [Mcallen / United States of America]
Avid Medical, Inc. - Form 483, 2022-12-05
$289 - Available for instant download
Issued On: December, 2022
Inspection Type: FDA 483
Site Name: Avid Medical, Inc. [Toano / United States of America]
Rebuilder Medical, Inc. - Form 483, 2022-11-29
$289 - Available for instant download
Issued On: November, 2022
Inspection Type: FDA 483
Site Name: Rebuilder Medical, Inc. [Charles Town / United States of America]
Abbott Medical - Form 483, 2022-11-23
$289 - Available for instant download
Issued On: November, 2022
Inspection Type: FDA 483
Site Name: Abbott Medical [Arecibo / United States of America]
B Braun Medical Inc - Form 483, 2022-11-22
$289 - Available for instant download
Issued On: November, 2022
Inspection Type: FDA 483
Site Name: B Braun Medical Inc [Daytona Beach / United States of America]
Caerus Corp. dba Orthocor Medical - Form 483, 2022-11-22
$289 - Available for instant download
Issued On: November, 2022
Inspection Type: FDA 483
Site Name: Caerus Corp. dba Orthocor Medical [Blaine / United States of America]
Spirus Medical, LLC - Form 483, 2022-11-18
$289 - Available for instant download
Issued On: November, 2022
Inspection Type: FDA 483
Site Name: Spirus Medical, LLC [West Bridgewater / United States of America]
University Medical Center IRB - Form 483, 2022-11-18
$289 - Available for instant download
Issued On: November, 2022
Inspection Type: FDA 483
Site Name: University Medical Center IRB [Las Vegas / United States of America]
CSI Medical, INC dba Boyd Corporation - Form 483, 2022-11-18
$289 - Available for instant download
Issued On: November, 2022
Inspection Type: FDA 483
Site Name: CSI Medical, INC dba Boyd Corporation [Gallatin / United States of America]
Reliance Medical Systems LLC - Form 483, 2022-11-17
$289 - Available for instant download
Issued On: November, 2022
Inspection Type: FDA 483
Site Name: Reliance Medical Systems LLC [Bountiful / United States of America]
Shin Chang Medical Co., Ltd. - Form 483, 2022-11-17
$289 - Available for instant download
Issued On: November, 2022
Inspection Type: FDA 483
Site Name: Shin Chang Medical Co., Ltd. [- / -]
Olympus Medical Systems Corp. - Form 483, 2022-11-10
$289 - Available for instant download
Issued On: November, 2022
Inspection Type: FDA 483
Site Name: Olympus Medical Systems Corp. [Nishitama-Gun / Japan]
Boule Medical AB - Form 483, 2022-11-10
$289 - Available for instant download
Issued On: November, 2022
Inspection Type: FDA 483
Site Name: Boule Medical AB [Spanga / Sweden]
Contract Medical International spol. sr.o. - Form 483, 2022-11-09
$289 - Available for instant download
Issued On: November, 2022
Inspection Type: FDA 483
Site Name: Contract Medical International spol. sr.o. [Hradec Kralove 3 / Czechia]
Neway Medical, P.C. - Form 483, 2022-11-08
$289 - Available for instant download
Issued On: November, 2022
Inspection Type: FDA 483
Site Name: Neway Medical, P.C. [New York / United States of America]
Stat Medical Devices, Inc. - Form 483, 2022-11-07
$289 - Available for instant download
Issued On: November, 2022
Inspection Type: FDA 483
Site Name: Stat Medical Devices, Inc. [North Miami Beach / United States of America]
Pharmedica USA, LLC - Form 483, 2022-11-07
$289 - Available for instant download
Issued On: November, 2022
Inspection Type: FDA 483
Site Name: Pharmedica USA, LLC [Phoenix / United States of America]
Ace Medical Corp., Ltd. - Form 483, 2022-11-03
$289 - Available for instant download
Issued On: November, 2022
Inspection Type: FDA 483
Site Name: Ace Medical Corp., Ltd. [- / -]
Illuminoss Medical Inc. - Form 483, 2022-11-02
$289 - Available for instant download
Issued On: November, 2022
Inspection Type: FDA 483
Site Name: Illuminoss Medical Inc. [East Providence / United States of America]
Cyber Medical Imaging Inc - Form 483, 2022-10-31
$289 - Available for instant download
Issued On: October, 2022
Inspection Type: FDA 483
Site Name: Cyber Medical Imaging Inc [Los Angeles / United States of America]
Terumo Medical Corporation - Form 483, 2022-10-28
$289 - Available for instant download
Issued On: October, 2022
Inspection Type: FDA 483
Site Name: Terumo Medical Corporation [Elkton / United States of America]
inx Medical, LLC - Form 483, 2022-10-27
$289 - Available for instant download
Issued On: October, 2022
Inspection Type: FDA 483
Site Name: inx Medical, LLC [Chesterfield / United States of America]
Primrose Medical Inc. - Form 483, 2022-10-26
$289 - Available for instant download
Issued On: October, 2022
Inspection Type: FDA 483
Site Name: Primrose Medical Inc. [East Walpole / United States of America]
Siemens Medical Solutions USA, Inc - Form 483, 2022-10-26
$289 - Available for instant download
Issued On: October, 2022
Inspection Type: FDA 483
Site Name: Siemens Medical Solutions USA, Inc [Malvern / United States of America]
Respire Medical Holdings, LLC - Form 483, 2022-10-25
$289 - Available for instant download
Issued On: October, 2022
Inspection Type: FDA 483
Site Name: Respire Medical Holdings, LLC [Brooklyn / United States of America]
Symmetry Medical Manufacturing, Inc. - Form 483, 2022-10-21
$289 - Available for instant download
Issued On: October, 2022
Inspection Type: FDA 483
Site Name: Symmetry Medical Manufacturing, Inc. [Manchester / United States of America]
UCSF Medical Center Clinical Laboratories Transfusion Service at Mission Bay - Form 483, 2022-10-17
$289 - Available for instant download
Issued On: October, 2022
Inspection Type: FDA 483
Biosearch Medical Products, Inc. - Form 483, 2022-10-11
$289 - Available for instant download
Issued On: October, 2022
Inspection Type: FDA 483
Site Name: Biosearch Medical Products, Inc. [Concord / United States of America]
UCI Medical Center C/O Blood Bank - Form 483, 2022-09-29
$289 - Available for instant download
Issued On: September, 2022
Inspection Type: FDA 483
Site Name: UCI Medical Center C/O Blood Bank [Orange / United States of America]
MHC Medical Products LLC - Form 483, 2022-09-23
$289 - Available for instant download
Issued On: September, 2022
Inspection Type: FDA 483
Site Name: MHC Medical Products LLC [Fairfield / United States of America]
3D Medical Manufacturing, Inc. - Form 483, 2022-09-15
$289 - Available for instant download
Issued On: September, 2022
Inspection Type: FDA 483
Site Name: 3D Medical Manufacturing, Inc. [Pennsauken / United States of America]
Dalton Medical Corp - Form 483, 2022-09-15
$289 - Available for instant download
Issued On: September, 2022
Inspection Type: FDA 483
Site Name: Dalton Medical Corp [Farmers Branch / United States of America]
Olympus Medical Systems Corporation - Form 483, 2022-09-09
$289 - Available for instant download
Issued On: September, 2022
Inspection Type: FDA 483
Site Name: Olympus Medical Systems Corporation [Hachioji / Japan]
Sea-Long Medical Systems, LLC - Form 483, 2022-09-08
$289 - Available for instant download
Issued On: September, 2022
Inspection Type: FDA 483
Site Name: Sea-Long Medical Systems, LLC [Waxahachie / United States of America]
Lucero Medical LLC - Form 483, 2022-09-07
$289 - Available for instant download
Issued On: September, 2022
Inspection Type: FDA 483
Site Name: Lucero Medical LLC [Richfield / United States of America]
Atrium Medical Corporation - Form 483, 2022-09-06
$289 - Available for instant download
Issued On: September, 2022
Inspection Type: FDA 483
Site Name: Atrium Medical Corporation [Merrimack / United States of America]
Columbia University Medical Center IRB - Form 483, 2022-08-31
$289 - Available for instant download
Issued On: August, 2022
Inspection Type: FDA 483
Site Name: Columbia University Medical Center IRB [New York / United States of America]
Savannah Health Services, LLC dba Memorial Health University Medical Center - Form 483, 2022-08-30
$289 - Available for instant download
Issued On: August, 2022
Inspection Type: FDA 483
Cedars-Sinai Medical Center - Form 483, 2022-08-26
$289 - Available for instant download
Issued On: August, 2022
Inspection Type: FDA 483
Site Name: Cedars-Sinai Medical Center [West Hollywood / United States of America]
Omega Medical Imaging, Inc. - Form 483, 2022-08-26
$289 - Available for instant download
Issued On: August, 2022
Inspection Type: FDA 483
Site Name: Omega Medical Imaging, Inc. [Sanford / United States of America]
SALUDA MEDICAL PTY. LTD. - Form 483, 2022-08-25
$289 - Available for instant download
Issued On: August, 2022
Inspection Type: FDA 483
Site Name: SALUDA MEDICAL PTY. LTD. [Park / Australia]
Excite Medical of Tampa Bay LLC - Form 483, 2022-08-25
$289 - Available for instant download
Issued On: August, 2022
Inspection Type: FDA 483
Site Name: Excite Medical of Tampa Bay LLC [Tampa / United States of America]
Nexera Medical, Inc. - Form 483, 2022-08-23
$289 - Available for instant download
Issued On: August, 2022
Inspection Type: FDA 483
Site Name: Nexera Medical, Inc. [Fort Lauderdale / United States of America]
Probed Medical Technologies, Inc. - Form 483, 2022-08-11
$289 - Available for instant download
Issued On: August, 2022
Inspection Type: FDA 483
Site Name: Probed Medical Technologies, Inc. [Abbotsford / Canada]
Breas Medical AB - Form 483, 2022-08-10
$289 - Available for instant download
Issued On: August, 2022
Inspection Type: FDA 483
Site Name: Breas Medical AB [Molnlycke / Sweden]
Valley Health/Winchester Medical Center IRB - Form 483, 2022-08-09
$289 - Available for instant download
Issued On: August, 2022
Inspection Type: FDA 483
Site Name: Valley Health/Winchester Medical Center IRB [Winchester / United States of America]
Allison Medical, Inc. - Form 483, 2022-07-29
$289 - Available for instant download
Issued On: July, 2022
Inspection Type: FDA 483
Site Name: Allison Medical, Inc. [Littleton / United States of America]
Norfolk Medical Products Inc - Form 483, 2022-07-26
$289 - Available for instant download
Issued On: July, 2022
Inspection Type: FDA 483
Site Name: Norfolk Medical Products Inc [Skokie / United States of America]
Rockwell Medical - Form 483, 2022-07-25
$289 - Available for instant download
Issued On: July, 2022
Inspection Type: FDA 483
Site Name: Rockwell Medical [Grapevine / United States of America]
Kem Medical Products Corp - Form 483, 2022-07-21
$289 - Available for instant download
Issued On: July, 2022
Inspection Type: FDA 483
Site Name: Kem Medical Products Corp [Hauppauge / United States of America]
Signifier Medical Technologies, Llc - Form 483, 2022-07-15
$289 - Available for instant download
Issued On: July, 2022
Inspection Type: FDA 483
Site Name: Signifier Medical Technologies, Llc [Needham Heights / United States of America]
Stony Brook Community Medical PC - Island Fertility - Form 483, 2022-07-13
$289 - Available for instant download
Issued On: July, 2022
Inspection Type: FDA 483
Site Name: Stony Brook Community Medical PC - Island Fertility [Commack / United States of America]
LISI MEDICAL Remmele, Inc - Form 483, 2022-07-12
$289 - Available for instant download
Issued On: July, 2022
Inspection Type: FDA 483
Site Name: LISI MEDICAL Remmele, Inc [Coon Rapids / United States of America]
Medical-technical Gases, Inc. - Form 483, 2022-07-08
$289 - Available for instant download
Issued On: July, 2022
Inspection Type: FDA 483
Site Name: Medical-technical Gases, Inc. [North Billerica Massachusetts / United States of America]
Medical Machining Technologies LLC dba Med Tech LLC - Form 483, 2022-06-30
$289 - Available for instant download
Issued On: June, 2022
Inspection Type: FDA 483
Site Name: Medical Machining Technologies LLC dba Med Tech LLC [Millington / United States of America]
Avalign Integrated Medical Solutions, Inc. - Form 483, 2022-06-28
$289 - Available for instant download
Issued On: June, 2022
Inspection Type: FDA 483
Site Name: Avalign Integrated Medical Solutions, Inc. [Mentor / United States of America]
Knox Medical Diagnostics, Inc. - Form 483, 2022-06-21
$289 - Available for instant download
Issued On: June, 2022
Inspection Type: FDA 483
Site Name: Knox Medical Diagnostics, Inc. [San Francisco / United States of America]
TriReme Medical, LLC. - Form 483, 2022-06-17
$289 - Available for instant download
Issued On: June, 2022
Inspection Type: FDA 483
Site Name: TriReme Medical, LLC. [Pleasanton / United States of America]
Medical Measurement Systems B.V. - Form 483, 2022-06-16
$289 - Available for instant download
Issued On: June, 2022
Inspection Type: FDA 483
Site Name: Medical Measurement Systems B.V. [Enschede / Netherlands]
Sanmina Sci Israel Medical Systems Ltd. - Form 483, 2022-06-16
$289 - Available for instant download
Issued On: June, 2022
Inspection Type: FDA 483
Site Name: Sanmina Sci Israel Medical Systems Ltd. [Maalot / Israel]
Zynex Medical, Inc - EIR, 2022-06-15
$1190 - Available for instant download
Issued On: June, 2022
Inspection Type: EIR
Site Name: Zynex Medical, Inc [Englewood / United States of America]
Zynex Medical, Inc - Form 483, 2022-06-15
$289 - Available for instant download
Issued On: June, 2022
Inspection Type: FDA 483
Site Name: Zynex Medical, Inc [Englewood / United States of America]
Zoll Medical Corporation - Form 483, 2022-06-13
$289 - Available for instant download
Issued On: June, 2022
Inspection Type: FDA 483
Site Name: Zoll Medical Corporation [Deerfield / United States of America]
Infinite Biomedical Technologies - Form 483, 2022-06-10
$289 - Available for instant download
Issued On: June, 2022
Inspection Type: FDA 483
Site Name: Infinite Biomedical Technologies [Baltimore / United States of America]
SQ Medical Supplies Inc. - Form 483, 2022-06-10
$289 - Available for instant download
Issued On: June, 2022
Inspection Type: FDA 483
Site Name: SQ Medical Supplies Inc. [City Of Industry / United States of America]
American Fertility Medical Center - Genetic Infertility & Andrology Laboratory, Inc. - Form 483, 2022-06-09
$289 - Available for instant download
Issued On: June, 2022
Inspection Type: FDA 483
Oticon Medical - Form 483, 2022-06-02
$289 - Available for instant download
Issued On: June, 2022
Inspection Type: FDA 483
Site Name: Oticon Medical [Vallauris / France]
BK Medical Holding Company - Form 483, 2022-05-27
$289 - Available for instant download
Issued On: May, 2022
Inspection Type: FDA 483
Site Name: BK Medical Holding Company [Burlington / United States of America]
Saint Bernards Medical Center IRB - Form 483, 2022-05-26
$289 - Available for instant download
Issued On: May, 2022
Inspection Type: FDA 483
Site Name: Saint Bernards Medical Center IRB [Jonesboro / United States of America]