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

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Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management System

FDA 510(k)
FDA Class 2 ·Cardiovascular

Dornier MedTech

FDA UDI
DORNIER MEDTECH AMERICA, INC.·00810116022540·600 micron core/1040 micron OD Luer Lock Diode ...

Dornier MedTech

FDA UDI
DORNIER MEDTECH AMERICA, INC.·00810116022526·400 micron core/730 micron OD Luer Lock Diode L...

36M - Black & Veach - Metal

FDA UDI
Certified Safety Manufacturing, Inc.·00766588011820·36M - Black & Veach - Metal

Sklar®

FDA UDI
SKLAR CORPORATION·10649111151262·SKLIT METZEN SCISS CVD 7"

ELI 200+ AUDICOR

FDA 510(k)
FDA Class 2 ·Cardiovascular

MULTIFIX S KNOTLESS FIXATION DEVICE

FDA 510(k)
FDA Class 2 ·Orthopedic

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·August 20, 2025

FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE (SG)·Product code FRN·November 17, 2008

CUSTOM PAK

FDA Adverse Event
Injury ·ALCON - HOUSTON·Product code KDD·August 26, 2011

TITANIUM ROOF PILE SCREW 45MM

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDJ·July 17, 2013

BD INTIMA-II Y 22GAX1.00IN PRN/EC SLM

FDA Adverse Event
Injury ·BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU·Product code FOZ·October 29, 2021

INTIMA-II Y 22GAX1.00IN PRN/EC SLM

FDA Adverse Event
Malfunction ·BD (SUZHOU)·Product code FOZ·June 28, 2021

RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.

FDA Enforcement
Class II ·Terminated·DePuy Orthopaedics, Inc.·July 30, 2014