16 results · 23ms · Sources: EU EUDAMED, US FDA

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Joule System

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

MOLDEX-METRIC HEALTH CARE N95 PARTICULATE RESPIRATOR AND SURGICAL MASK, MODEL 1712

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

Q-STRESS AND HEARTSTRIDE, MODELS QSTRESS/Q40 AND H4/H4S

FDA 510(k)
FDA Class 2 ·Cardiovascular

FASTTAKE

FDA Adverse Event
Malfunction ·LIFESCAN, INC.·Product code CFR·August 14, 2002

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·July 14, 2025

TRUETRACK

FDA Adverse Event
Malfunction ·TRIVIDIA HEALTH, INC.·Product code NBW·September 13, 2016

GLIDESHEATH SLENDER NITINOL (CONVENIENCE KIT)

FDA Adverse Event
Malfunction ·TERUMO MEDICAL CORPORATION·Product code DYB·February 21, 2018

EON MINI

FDA Adverse Event
Injury ·ST. JUDE MEDICAL -NEUROMODULATION·Product code LGW·June 14, 2013

LIVEWIRE STEERABLE DUO-DECA

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL·Product code DRF·July 5, 2011

SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·October 17, 2014

OT VERIO IQ METER

FDA Adverse Event
Injury ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 2, 2016

SFXSPI PDS+ UNI VIO 6IN 3-0 SA SH

FDA Adverse Event
Malfunction ·ETHICON INC.·Product code NEW·October 24, 2024

GLIDESHEATH SLENDER NITINOL (CONVENIENCE KIT)

FDA Adverse Event
Injury ·TERUMO MEDICAL CORPORATION·Product code DYB·May 4, 2018

GLIDESHEATH SLENDER NITINOL (CONVENIENCE KIT)

FDA Adverse Event
Malfunction ·TERUMO MEDICAL CORPORATION·Product code DYB·December 16, 2019

Allura CV20, system code 722031

FDA Enforcement
Class II ·Terminated·Philips North America, LLC·March 25, 2020

TDC VELOCE", 25G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT25, 9311.25G01, 9311.25G02, 9311.25K01, 9311.25K02, 9311.25K03, 9625.G0201;

FDA Enforcement
Class II ·Ongoing·D.O.R.C. Dutch Opthalmic Research Center Intl B.V.·June 17, 2026