7 results
·
26ms
·
Sources: EU EUDAMED, US FDA
ANGIODYNAMICS ANGIOSTENT BILIARY STENT SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VITEK 2 GRAM NEGATIVE DORIPENEM
FDA 510(k)
FDA Class 2
·Microbiology
TRULIANT Porous Tibial Tray and Exactech Alteon Bone Screws
FDA 510(k)
FDA Class 2
·Orthopedic
UNIDENTIFIED ACETABULAR CUP
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·February 28, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·August 5, 2014
POWER PRO AMBULANCE COT
FDA Adverse Event
Malfunction
·STRYKER CORP., MEDICAL DIV.·Product code INK·January 13, 2011
Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024