12 results
·
22ms
·
Sources: EU EUDAMED, US FDA
INVOTEC X-RAY CASSETTE EQUIPMENT DRAPE
FDA 510(k)
FDA Class 2
·Radiology
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756392815·CVIR PACK
MINI VARIABLE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
WATERLASE, MILLENNIUM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
IV SET TUR Y-TUBE
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FPA·April 9, 2020
ONCOSMART PROGUIDE NEEDLE
FDA Adverse Event
Other
·NUCLETRON·Product code JAQ·January 9, 2013
ANEURX AAADVANTAGE STENT GRAFT SYSTEM - HYDRO
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR·Product code MIH·November 24, 2010
CURRENT PLUS DR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·July 2, 2014
IV SET TUR Y-TUBE
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FPA·April 8, 2020
IV SET TUR Y-TUBE
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code LHI·April 8, 2020
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
BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 15, 2021