9 results
·
25ms
·
Sources: EU EUDAMED, US FDA
ORIMS DIGITAL ANGIOGRAPHY SYSTEM
FDA 510(k)
FDA Class 2
·Ophthalmic
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471150669·K-WIRE - SINGLE TROCAR THREADED 2.4mm DIA x 200mm
3M™ Victory Series™
FDA UDI
3M UNITEK CORPORATION·00652221116185·3M™ Victory Series™ First Molar Bands, 952-480,...
Revitive Medic; Revitive MV; Revitive LV
FDA 510(k)
FDA Class 2
·Physical Medicine
HANSEN MEDICAL CATHETER CONTROL SYSTEM (CCS) AND ACCESSORIES, HANSEN MEDICAL STEERABLE GUIDE CATHETER (SGC) AND SHEATH
FDA 510(k)
FDA Class 2
·Cardiovascular
CARELINK
FDA Adverse Event
Malfunction
·RICE CREEK MANUFACTURING·Product code DXY·February 9, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 23, 2014
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·January 7, 2011
HIGH PRESSURE ROTATOR (Component) a. WITH MALE LUER LOCK, Model Number MX496HP b. WITH FEMALE LUER LOCK, Model Number MX497HP. component of extravascular blood-pressure Transducer.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD Inc.·April 28, 2021