26 results · 37ms · Sources: EU EUDAMED, US FDA

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SYNCHRON SYSTEMS DIRECT LDL CHLOESTEROL REAGENT AND CALIBRATOR

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

ADVANCE®

FDA UDI
Microport Orthopedics Inc.·M684K00141031·

Argus ll Communication Adapter

FDA UDI
Second Sight Medical Products, Inc.·00856264005400·A device which provides data communication and ...

Argus II Communication Adapter (CA)

FDA UDI
CORTIGENT, INC.·00850052743055·A device which provides data communication and ...

CosmoLock Pedicle Screw System

FDA UDI
Kalitec Direct LLC·B07311K0140030·Cap Starter, T30, Split Tip, Quarter Square

CosmoLock Pedicle Screw System

FDA UDI
Kalitec Direct LLC·B07310K0140030·Counter Torque, Tower Tab

FOSTER GRANT

FDA UDI
FGX INTERNATIONAL INC.·00193033569375·

BD SPRING BASED SYRINGE

FDA 510(k)
FDA Class 2 ·General Hospital

SURSHIELD WINGED INFUSION SET

FDA 510(k)
FDA Class 2 ·General Hospital

ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG

FDA Adverse Event
Injury ·COOK INC·Product code MIH·November 23, 2015

ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG

FDA Adverse Event
Injury ·COOK INC·Product code MIH·November 23, 2015

ENDOTAK RELIANCE G

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LWS·August 2, 2023

ENDOTAK RELIANCE

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LWS·August 2, 2023

ENDOTAK RELIANCE

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code LWS·August 2, 2023

ENDOTAK RELIANCE G

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code LWS·August 2, 2023

OT VERIO IQ METER

FDA Adverse Event
Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 21, 2013

TENDRIL SDX

FDA Adverse Event
Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·March 10, 2011

EDWARDS MC3 TRICUSPID ANNULOPLASTY SYSTEM

FDA Adverse Event
Other ·EDWARDS LIFESCIENCES·Product code KRH·March 12, 2008

O-Ring Abutment 4.1mm(D) x 2mm(H) Item: OSO20 Dental implants

FDA Enforcement
Class II ·Terminated·Biomet 3i, LLC·August 24, 2016

VALIANT STENT GRAFT

FDA Adverse Event
Injury ·MEDTRONIC IRELAND·Product code MIH·September 15, 2015