24 results · 22ms · 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.

BURR HOLE COVER, MODEL XX

FDA 510(k)
FDA Class 2 ·Neurology

artVeneer life

FDA UDI
Merz Dental GmbH·D7092001096·artVeneer life lower anteriors, UIL, A3

Epredia

FDA UDI
RICHARD-ALLAN SCIENTIFIC COMPANY·00673693214674·Cassettes are designed to contain incised tissu...

Synergy Disc Instruments

FDA UDI
Synergy Spine Solutions Inc·M67091000010960·Pilot Cutter, Large, 6mm

ACCESS MYOGLOBIN ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33310, 33315, 33319, 33316

FDA 510(k)
FDA Class 2 ·Immunology

ONTRAK TESTSTIK FOR METHAMPHETAMINE, CAT. 1986686

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

CARDIOSAVE HYBRID, TYPE B PLUG

FDA Adverse Event
Malfunction ·DATASCOPE CORP.·Product code DSP·February 12, 2026

CS100

FDA Adverse Event
Malfunction ·DATASCOPE CORP.·Product code DSP·August 22, 2014

GYNECARE MORCELLEX TISSUE MORCELLATOR

FDA Adverse Event
Malfunction ·ETHICON, INC.·Product code HET·November 30, 2007

GEMSTR 7 THPY ALT ST

FDA Adverse Event
Malfunction ·HOSPIRA, INC.·Product code FRN·October 5, 2011

PELVICOL 2CM X 7CM 1.0MM

FDA Adverse Event
Injury ·COVIDIEN, FORMERLY TISSUE SCIENCE LABORATORIES·Product code FTL·March 5, 2013

3D KNEE

FDA Adverse Event
Other ·ENCORE MEDICAL, L.P.·Product code JWH·February 16, 2011

INTRAFIX SCREWS, 8-10MM X 30MM

FDA Adverse Event
Injury ·DEPUY MITEK·Product code MBI·February 22, 2008

EVERFLEX SELF-EXPANDING PERIPHERAL STENT WITH ENTRUST DELIVERY SYSTEM LONG

FDA Adverse Event
Injury ·COVIDIEN·Product code NIP·September 12, 2024

FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME

FDA Adverse Event
Malfunction ·WILSON-COOK MEDICAL INC.·Product code KNS·March 19, 2014

CS100,ENGLISH,NON-UTS,DOM

FDA Adverse Event
Malfunction ·DATASCOPE CORP. - MAHWAH·Product code DSP·April 12, 2023

Cronus Endovascular Guidewire, Length 300 cm (partial coat), Diameter 0.014 inch, Part Number 001-001096-4

FDA Recall
Terminated ·Stereotaxis Inc·Product code NFN·January 27, 2004

Cronus Endovascular Guidewire, Length 210 cm (full coat), Diameter 0.014 inch, Part Number 001-001096-1

FDA Recall
Terminated ·Stereotaxis Inc·Product code NFN·January 27, 2004

Cronus Endovascular Guidewire, Length 210 cm (partial coat), Diameter 0.014 inch, Part Number 001-001096-3

FDA Recall
Terminated ·Stereotaxis Inc·Product code NFN·January 27, 2004

Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

FDA Enforcement
Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013