13 results · 19ms · 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 Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)

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

Armada

FDA UDI
Nuvasive, Inc.·00887517223005·ARM15T Screw, 4x25mm PLS

MORRISON MEDICAL

FDA UDI
MORRISON MEDICAL, LTD·00647921254022·CORR.PLSTC.SPLNT.24"CTR.FM./25

Phantom

FDA UDI
Innovative Med·00851314007038·Surgical Aspirator:1/3 hp. 0-3.6 scfm / 0-27.5 ...

NA

FDA UDI
Exactech, Inc.·10885862525420·TRIAL, TIBIAL ADAPTOR, PLATE, SIZE 2.5

PROWLER SELECT LP ES Microcatheter; PROWLER XS Microcatheter

FDA 510(k)
FDA Class 2 ·Cardiovascular

22.2mm BIOLOX® delta Ceramic V40™ Femoral Heads

FDA 510(k)
FDA Class 2 ·Orthopedic

BD PLATE MAC CONKEY II AGAR 90MM

FDA Adverse Event
Malfunction ·BECTON DICKINSON GMBH·Product code JSI·February 28, 2022

ENDOWRIST SMALL CLIP APPLIER (DA VINCI)

FDA Adverse Event
Malfunction ·INTUITIVE SURGICAL·Product code NAY·June 26, 2013

IMPLANTABLE CHF GENERATOR

FDA Adverse Event
Product code NIK·November 11, 2008

X7000 XENON LIGHTSOURCE

FDA Adverse Event
Malfunction ·STRYKER ENDOSCOPY - SAN JOSE·Product code FCW·August 11, 2011

ACCOLADE DR SL MRI (Model L311)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

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