61 results · 21ms · Sources: EU EUDAMED, US FDA

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ACCU NEWS Drug Screening Test Card/Urine Cup

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

BR2000 BLADES

FDA UDI
Peter Brasseler Holdings, LLC·00887919739159·K5-2590-58

BR2000 BLADES

FDA UDI
Peter Brasseler Holdings, LLC·00887919100317·K5-2590-50

BR2000 BLADES

FDA UDI
Peter Brasseler Holdings, LLC·00887919100300·K5-2590-47

Endo-Model Knee System - Instruments

FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575313716·Radiographic image marker, manual - Endo Model ...

BR2000 BLADES

FDA UDI
Peter Brasseler Holdings, LLC·00887919100294·K5-2590-39

Endo-Model Knee System - Instruments

FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575403059·Orthopaedic implant inserter/extractor, reusabl...

BR2000 BLADES

FDA UDI
Peter Brasseler Holdings, LLC·00887919739128·K5-2590-35

RADIFOCUS GLIDEWIRE ADVANTAGE, RADIFOCUS GLIDEWIRE ADVANTAGE

FDA 510(k)
FDA Class 2 ·Cardiovascular

FLEBOSET DOUBLE

FDA 510(k)
FDA Class 2 ·General Hospital

TARGET TIP

FDA Adverse Event
Malfunction ·MPRI·Product code DTB·June 7, 2013

OCTRODE PERCUTANEOUS LEAD

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 27, 2011

RECIPROCATING/OSCILLATING SAW/MODULAT HANDPIECE

FDA Adverse Event
Injury ·CONMED LINVATEC·Product code HBC·October 2, 2014

RADIFOCUS GLIDEWIRE ADVANTAGE

FDA Adverse Event
Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DQX·May 1, 2020

GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 L

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·February 28, 2020

GLIDEWIRE ADVANTAGE

FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·July 9, 2025

RADIFOCUS GLIDEWIRE ADVANTAGE

FDA Adverse Event
Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DQX·June 23, 2022

GUIDE WIRE w/ BALL TIP 2.0MMX98CM; 469040 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.

FDA Enforcement
Class II ·Terminated·Zimmer Biomet, Inc.·June 27, 2018

CAPIOX RX OXYGENATOR

FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code DTZ·March 28, 2019

RADIFOCUS GLIDEWIRE ADVANTAGE

FDA Adverse Event
Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·February 3, 2025