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FDA 510(k)
FDA Class 2 ·Radiology

ARTiC-L™ Spinal System

FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00763000085322·TRIAL 5250800 L 25 HT 8 DEG 0 FIXED

ARTiC-L™ 3D Ti Spinal System with TiONIC™ Technology

FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169791053·TRIAL 5250800 L 25 HT 8 DEG 0 FIXED

Darby Dental Supply, LLC

FDA UDI
DARBY DENTAL SUPPLY, LLC·00889813035818·Reamers With Silicone Stops 31MM #15

Bosma Enterprises

FDA UDI
Bosma Enterprises·00818634025487·Opportunity Pro Nitrile Exam Glove Extra Small ...

JOBST Elvarex

FDA UDI
BSN-Jobst GmbH·04059993397549·ELVAREX 1/THIGH HIGH/SLANT-OPEN TOE/DOTED SIL. ...

JOBST Elvarex

FDA UDI
BSN-Jobst GmbH·04019702783384·ELVAREX 2/KNEE HIGH/SLANT-OPEN TOE-ELEPHANTIASI...

TALOS®-C HA

FDA UDI
MEDITECH SPINE, LLC·B167522508000·

BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II) // MACCONKEY II AGAR

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code JSG·December 29, 2023

Valved Safety Centesis Catheter

FDA 510(k)
FDA Class 1 ·General, Plastic Surgery

NIKI T34 AND BODYGUARD T34 SYRINGE DRIVERS

FDA 510(k)
FDA Class 2 ·General Hospital

Omnia Medical TiBrid™-L

FDA UDI
OMNIA MEDICAL, LLC·00843511106478·LATERAL INTERBODY, 22x45x8mm, 0°

LIGAMAX-5MM ENDO CLIP APPLIER

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC·Product code FZP·December 2, 2008

DISPOSABLE HIP BONEC

FDA Adverse Event
Malfunction ·SMITH & NEPHEW MANSFIELD MANUFACTURING SITE·Product code HAB·September 16, 2011

ENDURANT

FDA Adverse Event
Injury ·MEDTRONIC IRELAND·Product code MIH·July 29, 2013

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