40 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PALM-PRO 0.30MM POWDER FREE LATEX EXAMINAION GLOVES (6PF2G30)
FDA 510(k)
FDA Class 1
·General Hospital
Endo Carry-On Procedure Kit
FDA UDI
MEDIVATORS INC.·00677964061608·Endo Carry-on Procedure Kit includes Gauze, Bio...
BLALOCK FLEXIBLE CLAMP
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896090156·BLALOCK FLEXIBLE CLAMP SMOOTH TIP
BLALOCK FLEXIBLE CLAMP
FDA UDI
SONTEC INSTRUMENTS, INC.·B09921008950·BLALOCK FLEXIBLE CLAMP SMOOTH JAW
Spooled Nitanium
FDA UDI
Ortho Organizers, Inc.·00190707101022·.014 SPOOLED NITANIUM 10ft
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450504529·
Zavation
FDA UDI
Zavation LLC·00197157002268·9.5mm Cannulated Tap
STAT PROFILE PHOX PLUS ANALYZER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CENTRAL VISION ANALYZER MODEL 1000
FDA 510(k)
FDA Class 1
·Ophthalmic
Widex
FDA UDI
Widex A/S·05706069773620·Widex EVOKE E-FA, Telecoil, Volume control, RC ...
HAHN TAPERED IMPLANT Ø4.3 X 13 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·July 17, 2025
HAHN TAPERED IMPLANT Ø4.3 X 13 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·June 27, 2023
HAHN TAPERED IMPLANT Ø4.3 X 13 MM
FDA Adverse Event
Injury
·PRISMATIK DENTALCRAFT, INC.·Product code DZE·June 23, 2023
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·February 27, 2026
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 8, 2013
ACCU-CHEK ® SPIRIT COMBO
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LZG·September 19, 2014
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Death
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·May 24, 2011
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND V NECK, Product Code/List Number/Item Code 67PFS25; b) PEDIATRIC TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS30; c) PEDIATRIC TRACHEOSTOMY TUBE 3.5mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS35; d) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS40; e) PEDIATRIC TRACHEOSTOMY TUBE 4.5mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS45; f) PEDIATRIC TRACHEOSTOMY TUBE 5.0mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS50; g) PEDIATRIC TRACHEOSTOMY TUBE 5.5mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS55
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024
TherMax Blood Warmer Unit
FDA Enforcement
Class II
·Terminated·Baxter Healthcare Corporation·November 6, 2019
IVEA Product Part Number 16100 Model 500A
FDA Enforcement
Class II
·Terminated·Firefly Medical, Inc.·October 11, 2017