9 results
·
18ms
·
Sources: EU EUDAMED, US FDA
DERMATEK 4000
FDA 510(k)
FDA Class 2
·Physical Medicine
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756393553·HYSTEROSCOPY PACK
Park's Pectus System
FDA 510(k)
FDA Class 2
·Orthopedic
INTERCEPT ORAL FLUID DRUG TEST ORAL SPECIMEN COLLECTION DEVICE, MODEL 503-XXXX
FDA 510(k)
FDA Class 2
·Clinical Chemistry
UNKNOWN STRYKER TIBIAL COMPONENT
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS MAHWAH·Product code MEH·January 4, 2013
ENDEAVOR SPRINT RX CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR GALWAY·Product code NIQ·November 24, 2010
QUADRA ASSURA CRT-D, DF-4 CONNECTOR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code NIK·July 2, 2014
UNKNOWN
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code DTK·December 18, 2015
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024