40 results · 21ms · Sources: EU EUDAMED, 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