9 results
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26ms
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Sources: EU EUDAMED, US FDA
Ulthera® System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017972·K-Wire, Single Ended, Trocar Point, Diameter Si...
Vilex Guidewire
FDA UDI
VILEX IN TENNESSEE, INC.·00841731120700·Steinmann Pin 3.5x230mm (9/64 x 9")
SEPRAGEL ENT BIORESORBABLE PACKING/STENT
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Flight 60 Ventilator
FDA 510(k)
FDA Class 2
·Anesthesiology
DURALOC CONST LINER 54X32
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JDI·November 21, 2008
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·September 11, 2011
NELLCOR OXIMAX N-65
FDA Adverse Event
Malfunction
·SANMINA - SCI SYSTEMS·Product code DQA·July 18, 2013
Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/80cm, Catalog Number ASB5-35-80-6-4, REF Number G35252 Product Usage: The Advance Enforcer 35 Focal-Force PTA Balloon Catheter is intended for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, renal, popliteal, infrapopliteal, femoral and iliofemoral, as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the cerebral or coronary vasculature.
FDA Enforcement
Class I
·Terminated·Cook Inc.·June 26, 2019