138 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Sterilized Latex Surgical Gloves
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
APEX PS Knee
FDA UDI
Omni Life Science, Inc.·00841690113836·PS-C Insert, Size 6 x 20mm
36M - MSHA Miners
FDA UDI
Certified Safety Manufacturing, Inc.·00766588026206·36M - MSHA Miners
Dardik Multi-Purpose Clamp 17cm str.
FDA UDI
Geister Medizintechnik GmbH·04057034059654·Dardik Multi-Purpose Clamp 17cm str.
FlexCath Advance Steerable Sheath and Dilator
FDA 510(k)
FDA Class 2
·Cardiovascular
SHEATHLESS ACCESSORY KIT, MODELS XRIK24, XRIK28, XRIK32, XRIK36, XRIK40 AND XRIKRT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 14, 2025
Votion
FDA UDI
ORTHO TECHNOLOGY, INC.·00190730009692·Votion™ Mini .022 UL7 NC SBT -14T 0A 10DO DB (1...
Votion
FDA UDI
ORTHO TECHNOLOGY, INC.·00190730009531·Votion™ .022 UL6 NC SBT -14T 0A 10DO DB (10PK)
Votion™
FDA UDI
Ortho Organizers, Inc.·00190707109875·Votion™ .022 UL6 NC SBT -14T 0A 10DO DB (10PK)
Votion™
FDA UDI
Ortho Organizers, Inc.·00190707110031·Votion™ Mini .022 UL7 NC SBT -14T 0A 10DO DB (1...
NATURALYTE
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·October 31, 2014
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE-SINGAPORE·Product code FRN·August 25, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 12, 2013
VITEK 2 Gram Positive Susceptibility card (AST-GP67), REF 22226, 20 cards per carton.
FDA Recall
Terminated
·Biomerieux Inc·Product code LON·April 20, 2017
VITEK¿ 2 Gram Positive Susceptibility card (AST-GP67), REF 22226, 20 cards per carton.
FDA Enforcement
Class II
·Terminated·Biomerieux Inc·June 21, 2017
TruFit™
FDA UDI
Ortho Organizers, Inc.·00190707177577·TruFit™ 2.0 ASM .022 MC UL6 NC SBT -14T 10DOff ...
TruFit 2.0
FDA UDI
ORTHO TECHNOLOGY, INC.·00190730045263·TruFit™ 2.0 ASM .022 MC UL6 NC SBT -14T 10DOff ...
TruFit™
FDA UDI
Ortho Organizers, Inc.·00190707177560·TruFit™ 2.0 ASM .022 MC UL6 NC SBT -14T 10DOff ...
TruFit 2.0
FDA UDI
ORTHO TECHNOLOGY, INC.·00190730045171·TruFit™ 2.0 ASM .022 MC UL6 NC SBT -14T 10DOff ...