13 results · 20ms · 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.

Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory

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

Philips

FDA UDI
Sbo Hearing A/S·05714464091362·HEARLINK 1700 BTE PP TP

ELMED

FDA UDI
ELMED INCORPORATED·00842180136335·5MM, 33CM NEEDLE HOLDER, CURVED LEFT TUNGSTEN C...

Millennium

FDA UDI
Avalign Technologies, Inc.·00190776209117·LAP NH CVD LEFT TUNGSTEN CARBIDE TIP

LEONE IMPLANT SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

Straumann TLX Implant System

FDA 510(k)
FDA Class 2 ·Dental

IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM

FDA Adverse Event
Injury ·ZIMMER DENTAL·Product code DZE·October 3, 2023

IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM

FDA Adverse Event
Injury ·ZIMMER DENTAL·Product code DZE·October 3, 2023

HOMECHOICE PRO

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·November 14, 2014

ASR UNI FEMORAL IMPLANT SIZE 41

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL·Product code KWA·September 16, 2011

SMALL CLIP APPLIER INSTRUMENT

FDA Adverse Event
Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·July 26, 2013

BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

FDA Enforcement
Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

FDA Enforcement
Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013