16 results · 24ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

LED Light Therapy Silicone Face Mask (kks-225, kks-280, kks-281)

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

LOQTEQ®

FDA UDI
aap Implantate AG·04042409398667·LOQTEQ® VA Metatarsal Straight Plate 2.5, 7 hol...

ArteVu

FDA 510(k)
FDA Class 2 ·Cardiovascular

HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization Wrap

FDA 510(k)
FDA Class 2 ·General Hospital

IMP,TSV,4.1,13,MTX,MG

FDA Adverse Event
Injury ·ZIMMER DENTAL·Product code DZE·February 9, 2023

G7 VIVACIT E

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code LPH·May 19, 2026

AVENIR COMPLETE

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code LZO·May 19, 2026

BD BBL¿ COLUMBIA CNA AGAR WITH 5% SHEEP BLOOD

FDA Adverse Event
Malfunction ·BECTON DICKINSON GMBH·Product code JSJ·September 2, 2025

BD BBL¿ COLUMBIA CNA AGAR WITH 5% SHEEP BLOOD

FDA Adverse Event
Malfunction ·BECTON DICKINSON GMBH·Product code JSJ·September 2, 2025

BD BBL¿ COLUMBIA CNA AGAR WITH 5% SHEEP BLOOD

FDA Adverse Event
Malfunction ·BECTON DICKINSON GMBH·Product code JSJ·December 13, 2024

VITALITY DS VR

FDA Adverse Event
Malfunction ·CARDIAC PACEMAKERS, INC·Product code LWS·November 11, 2008

SM104 MSERIES W5TH

FDA Adverse Event
Malfunction ·STRYKER MEDICAL·Product code FPO·August 11, 2011

UNKNOWN LANCING DEVICE

FDA Adverse Event
Injury ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 30, 2013

BD BBL¿ COLUMBIA CNA AGAR WITH 5% SHEEP BLOOD

FDA Adverse Event
Malfunction ·BECTON DICKINSON GMBH·Product code JSJ·January 31, 2023

BD BBL¿ COLUMBIA CNA AGAR WITH 5% SHEEP BLOOD

FDA Adverse Event
Malfunction ·BECTON DICKINSON GMBH·Product code JSJ·July 28, 2022

Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias

FDA Enforcement
Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014