15 results · 34ms · Sources: EU EUDAMED, US FDA

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Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D 3D Anatomical Mesh, Versatex Monofilament Mesh

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

ELMED

FDA UDI
ELMED INCORPORATED·00842180135185·5 MM DIA., 33 CM BIPOLAR SPOT COAGULATOR ACCORD...

GOOD LUBRICATIONS

FDA 510(k)
FDA Class 1 ·General Hospital

CELL SAVER ELITE

FDA 510(k)
FDA Class 2 ·Anesthesiology

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·August 13, 2025

INFUSOR

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·August 23, 2011

POWERED WHEELCHAIR

FDA Adverse Event
Malfunction ·INVACARE REHABILITATION EQUIP·Product code ITI·November 3, 2014

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 11, 2013

BINAXNOW COVID-19 AG SELF TEST 2CT

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·February 16, 2023

ARCHITECT CA 19-9XR

FDA Adverse Event
Malfunction ·ABBOTT LABORATORIES·Product code NIG·April 27, 2017

ARCHITECT CA 19-9XR

FDA Adverse Event
Malfunction ·ABBOTT LABORATORIES·Product code NIG·April 27, 2017

ARCHITECT CA 19-9XR

FDA Adverse Event
Malfunction ·ABBOTT LABORATORIES·Product code NIG·April 27, 2017

BD CATHENA¿ SAFETY IV CATHETER

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·July 7, 2022

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

OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

FDA Enforcement
Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012