14 results · 20ms · Sources: EU EUDAMED, US FDA

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NeuroAmp II, NeuroAmp II.5s

FDA 510(k)
FDA Class 2 ·Neurology

BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO., (BD)·Product code JKA·September 14, 2022

PR CREAM

FDA 510(k)
FDA Unclassified ·Unknown

CARDIO MED MODEL A102, H104, O101, P103, AND Z100

FDA 510(k)
FDA Class 2 ·Cardiovascular

NEXTAR INFRARED CAMERA

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code JWH·September 10, 2021

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·August 5, 2024

PUMP MMT-722NAS PRDGM INS V2.2 SK EN

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code LZG·October 7, 2008

SPEEDSCREW 5.5 IMPLANT WITH INSERTER HANDLE

FDA Adverse Event
Malfunction ·ARTHROCARE CORPORATION·Product code HWC·June 25, 2013

CANE, CRUTCH AND WALKER TIPS AND PADS

FDA Adverse Event
Malfunction ·UNKNOWN·Product code INP·August 5, 2011

Cardio Medical Products, Inc. Defibrillation/Cardioversion/Monophasic or Biphasic Pacing/ECG Electrode Rx Only Single Patient Use Only Manufactured for Cardio Medical Products 385 Franklin Avenue, Suite L Rockaway, New Jersey 07866 www.cardiomedicalproducts.com (800) 227-3633 (973) 586-9624 FAX Defibrillator

FDA Enforcement
Class II ·Terminated·Cardio Medical Products·July 17, 2013

THORATEC® HEARTMATE 3¿ SYSTEM CONTROLLER

FDA Adverse Event
Malfunction ·THORATEC CORPORATION·Product code DSQ·August 13, 2024

COBAS 6000 E601 MODULE

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code CEM·February 28, 2012

TRUE METRIX

FDA Adverse Event
Malfunction ·TRIVIDIA HEALTH INC·Product code NBW·November 21, 2025

Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001. Product The Fetch 2 Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral and coronary vasculature.

FDA Enforcement
Class I ·Terminated·Boston Scientific Corporation·April 27, 2016