526 results · 29ms · 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.

MODIFICATION TO FLOWSCREEN

FDA 510(k)
FDA Class 2 ·Anesthesiology

EVOS Lumbar Interbody System

FDA UDI
Cutting Edge Spine, LLC·00841193104393·HA PEEK EVOS Curved, , 11mmx9mmx 26mm , BICONVE...

LEONE SPA

FDA UDI
LEONE SPA·08033707000204·PALATAL EXPANSION SCREW S/STEEL 11mm .

Cosmolock

FDA UDI
Kalitec Direct LLC·B07311K0120110·Assembly, Screwdriver, Polyaxial, Cannulated, L...

MODIFICATION TO A620 EEG

FDA 510(k)
FDA Class 2 ·Neurology

GLUTARTEST 1 REAGENT STRIP

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

UNKNOWN

FDA Adverse Event
Malfunction ·MEDTRONIC·Product code DTB·August 11, 2023

ENDOTRACH TUBE 8229980 5PK 8MM EMG FLEX

FDA Adverse Event
Injury ·MEDTRONIC XOMED, INC.·Product code ETN·October 11, 2013

TGS UKA KNEE SYSTEM

FDA Adverse Event
Injury ·ALEXANDRIA RESEARCH TECHNOLOGIES, INC.·Product code HSX·May 6, 2013

ANIMAS INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·November 2, 2011

ANIMAS INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·June 21, 2011

PIPELINE EMBOLIZATION DEVICE

FDA Adverse Event
Death ·EV3 NEUROVASCULAR·Product code OUT·February 27, 2013

ANIMAS INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·December 6, 2011

ANIMAS INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·September 29, 2011

SYSTEM, PERITONEAL AUTOMATIC DELIVERY

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE·Product code FKX·April 16, 2013

DEXTRUS

FDA Adverse Event
BOSTON SCIENTIFIC·Product code DTB·May 30, 2008

2800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 6, 2011

BV25+DIGITAL MEMORY

FDA Adverse Event
Malfunction ·PHILIPS HEALTHCARE·Product code IZL·March 2, 2011

ACRYSOF IQ TORIC

FDA Adverse Event
Injury ·ALCON RESEARCH, LTD. / HUNTINGTON·Product code HQL·September 30, 2011

DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE

FDA Adverse Event
Malfunction ·ST. JUDE MEDICAL·Product code NVN·August 12, 2023