103 results · 33ms · 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.

ELECTRONIC DIGITAL BP METER HC 3001

FDA 510(k)
FDA Class 2 ·Cardiovascular

HOMECHOICE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·December 12, 2013

ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE

FDA Adverse Event
Injury ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code DQX·February 26, 2008

HI-TORQUE BALANCE GUIDE WIRE WITH HYDROCOAT

FDA Adverse Event
Malfunction ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code DQX·April 2, 2008

FREESTYLE NAVIGATOR

FDA Adverse Event
Malfunction ·Product code LFR·March 12, 2010

FREESTYLE NAVIGATOR

FDA Adverse Event
Malfunction ·Product code LFR·March 12, 2010

FREESTYLE LIBRE 2 PLUS

FDA Adverse Event
Injury ·ABBOTT DIABETES CARE INC·Product code QBJ·April 29, 2026

MedTest DX Control Reconstitution Fluid Kit configuration: 20 x 5 ml. Bottle: 5 ml amber glass Cap: 18 mm white seal plug seal rubber HC-DIL (Human Control Diluent) is reagent grade water filled into 5ml vials used to reconstitute Human controls HNC200 and HEC200. in vitro diagnostic.

FDA Recall
Terminated ·MedtestDx, Inc.·Product code JJY·May 15, 2015

NC TREK CORONARY DILATATION CATHETER

FDA Adverse Event
Malfunction ·AV-TEMECULA-CT·Product code LOX·March 7, 2014

NC TREK CORONARY DILATATION CATHETER

FDA Adverse Event
Malfunction ·AV-TEMECULA-CT·Product code LOX·February 27, 2015

ECHELON

FDA Adverse Event
Injury ·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRA·September 23, 2024

THERASPHERE Y-90

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code NAW·April 28, 2026

QUANTUM PUREFLOW STANDARD HEAT EXCHANGER HIGH FLOW 3/8

FDA Adverse Event
Injury ·SPECTRUM MEDICAL S.R.L.·Product code DTR·October 30, 2025

HI-TORQUE BALANCE MIDDLEWEIGHT ELITE GUIDE WIRE

FDA Adverse Event
Malfunction ·AV-TEMECULA-CT·Product code DQX·October 30, 2012

DX-D600 -DXD IMAGING PACKAGE

FDA Adverse Event
Malfunction ·AGFA HEALTHCARE N.V.·Product code KPR·March 20, 2015

HI-TORQUE WHISPER LS GUIDE WIRE

FDA Adverse Event
Injury ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code DQX·October 19, 2010

ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYD

FDA Adverse Event
Injury ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code DQX·May 21, 2009

530G INSULIN PUMP MMT-751NAS

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·July 13, 2018

AMPHENOL DC ELECTRONICS

FDA registration
AMPHENOL DC ELECTRONICS·7 products·🇺🇸 United States

AMPHENOL DC ELECTRONICS

FDA registration
AMPHENOL DC ELECTRONICS·1 product·🇲🇽 Mexico