18 results · 22ms · Sources: EU EUDAMED, US FDA

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Examination gloves -Type C (Nitrile gloves)

FDA 510(k)
FDA Class 1 ·General Hospital

NuVasive

FDA UDI
Nuvasive, Inc.·00195377046857·NTS Slot Tube, 22x90mm Beveled

RAPIDIA

FDA 510(k)
FDA Class 2 ·Radiology

SUPERCATH Z3V

FDA 510(k)
FDA Class 2 ·General Hospital

BI-METRIC/X POR NC 7X115

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code LPH·April 27, 2026

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 30, 2014

TAXUS ELEMENT PACLITAXEL-ELUTING CORONARY STENT SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·August 15, 2011

ACCU-CHEK ® SPIRIT

FDA Adverse Event
Injury ·ROCHE HEALTH SOLUTIONS INC·Product code LZG·July 9, 2013

FRDM CNSTR HD 36MM T12/14 +6MM

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code LPH·May 13, 2022

FREEDOM CONSTR. LINER +5 SZ 25

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code KWZ·May 13, 2022

COMPREHENSIVE SHOULDER SYSTEM STANDARD TAPER ADAPTOR

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code MBF·February 1, 2017

HYBRID GLENOID BASE 4MM SMALL

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code KWS·February 1, 2017

PT HYBRID(TM) GLENOID POST REGENEREX(TM) POROUS TITANIUM CONSTRUCT

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code KWS·February 1, 2017

DEKA LIPOAI

FDA Adverse Event
Injury ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·August 4, 2025

MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

FDA Enforcement
Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 2024

BIOMET StageOne Knee Tibial Cement Spacer Mold, 75 MM, Silicone, Sterile, Item 433175.

FDA Enforcement
Class II ·Terminated·Biomet, Inc.·April 15, 2020

DRX Revolution Mobile X-Ray System

FDA Enforcement
Class II ·Ongoing·Carestream Health, Inc.·December 13, 2023

Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026