17 results · 25ms · Sources: EU EUDAMED, US FDA

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OPERATING ROOM TOWEL, STERILE, COLORS BLUE OR WHITE

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

Endo-Carry-on Procedure Kit

FDA UDI
MEDIVATORS INC.·40677964015838·Endo Carry-on Procedur Kit contains all of the ...

TruForm

FDA UDI
Rmo, Inc.·00885797099709·MX MLR BDS R/L SE ASIA ASST100

BD INTEGRA SYRINGE WITH DETACHABLE NEEDLE

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code MEG·August 20, 2019

MINIMED MIO

FDA Adverse Event
Injury ·UNOMEDICAL A/S·Product code FPA·February 4, 2025

BD INTEGRA¿ 3 ML RETRACTING SAFETY SYRINGE WITH 23 G X 1 IN.

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·December 13, 2022

MINIMED MIO

FDA Adverse Event
Injury ·UNOMEDICAL UM-D·Product code FPA·February 9, 2025

AUDIOSCREENER OAE + ABR

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

WEHRS INCUS-STAPES

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

LINOX TD 65/16

FDA Adverse Event
Malfunction ·BIOTRONIK SE & CO. KG·Product code NVY·March 13, 2013

TERUMO VIRTUOSAPH VEIN HARVESTING SYSTEM

FDA Adverse Event
TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code GCJ·February 21, 2011

ALENTI WITH SCALE

FDA Adverse Event
Malfunction ·ARJO HOSPITAL EQUIPMENT AB·Product code FSA·February 25, 2008

SURETEK?

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code MHY·September 9, 2025

BD Interlink threaded lock cannula This is a locking blunt plastic cannula specifically designed for IV connection to an Interlink¿ injection site. It is screwed down over the Interlink¿ injection site and a blunt plastic cannula inside the housing enters the Interlink¿ injection site to provide a pathway for IV fluid administration.

FDA Enforcement
Class II ·Terminated·Becton Dickinson & Company·January 22, 2014

PSS Select medical products***Biopsy Punches*** Disposable manual instrument for skin biopsy.

FDA Enforcement
Class II ·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013

CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

FDA Enforcement
Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quadra Assura MP, Model No. CD3269-40, CD3269-40Q, CD3369-40C. Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing. Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing

FDA Enforcement
Class I ·Terminated·St Jude Medical Inc.·November 2, 2016