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