23 results · 23ms · 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.

ANGEL OF WATER COLON HYDROTHERAPY SYSTEM

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

Premier Composite Instruments

FDA UDI
PREMIER DENTAL PRODUCTS COMPANY·00348783009781·CPF DE_S6

Inclusive

FDA UDI
Preat Corporation·00842092100103·Multi-Unit Gold/Plastic Coping

SCANLAN® Titanium Forceps

FDA UDI
SCANLAN INTERNATIONAL INC·00846159003536·Dennis Micro Forceps, RH, straight, 1 mm DD rin...

QUASAR

FDA UDI
Modus Medical Devices Inc·G34350037200·MRgRT Insight - Ion Chamber Holder

SYNTHES SACRAL BAR SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

SOMNUS DISPOSABLE TISSUE COAGULATING ELECTRODE AND SOMNUS REUSABLE CONNECTOR CABLE

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

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·January 6, 2025

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDICS·Product code KWP·January 26, 2012

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Malfunction ·WARSAW ORTHOPEDICS·Product code KWP·January 26, 2012

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDIC INC.·Product code KWP·October 15, 2009

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDIC INC.·Product code KWP·December 31, 2009

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDIC INC.·Product code KWP·October 29, 2009

AUTOPULSE NIMH BATTERY

FDA Adverse Event
Malfunction ·ZOLL CIRCULATION, INC.·Product code DRM·February 11, 2013

ARCTIC FRONT CARDIAC CRYOABLATION CATHETER

FDA Adverse Event
Injury ·MEDTRONIC CRYOCATH LP·Product code OAE·February 23, 2011

8010652-2008-00001

FDA Adverse Event
Other ·Product code FQO·February 7, 2008

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·May 21, 2010

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·May 21, 2010

VERTEX RECONSTRUCTION SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDIC INC.·Product code KWP·August 13, 2010

Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000

FDA Enforcement
Class I ·Ongoing·Covidien·November 8, 2023