8 results
·
17ms
·
Sources: EU EUDAMED, US FDA
SINOJECT MAXILLARY SINUS PUNCTURE & IRRIGATION SYS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471150577·K-WIRE - DOUBLE TROCAR 1.4mm DIA x 125mm
LANX SPINAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
OVER THE WIRE EMBOLECTOMY CATHETER, MODEL 2302
FDA 510(k)
FDA Class 2
·Cardiovascular
TANDEM T:SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES·Product code LZG·May 30, 2014
VIRTUOSO DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code LWS·December 13, 2010
DURA DURATION A/P TIB SM 9
FDA Adverse Event
Injury
·STRYKER ORHTOPAEDICS CORK·Product code MBH·January 14, 2013
Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay System REAGENT PACK
FDA Enforcement
Class II
·Ongoing·Beckman Coulter Inc.·October 13, 2021