10 results
·
27ms
·
Sources: EU EUDAMED, US FDA
ABUSCREEN ONLINE CANNABINOIDS CALIBRATORS
FDA 510(k)
FDA Class 2
·Clinical Toxicology
REVELATION DIAMOND
FDA UDI
Ss White Burs, Inc.·D6909100852·REVELATION DIAMOND 802-014M - 5 PACK
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756972895·THORACOSCOPY PACK
neon³ CT spinal stabilization
FDA UDI
Ulrich GmbH & Co. KG·04052536161386·Rod, titanium alloy, Ø 4.0 mm, length 85 mm
VANTAGE VIEW SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
EEG REAL PATIENT SPIKE AND EVENT DETECTOR MODULE, MODEL EX-SP-RP (PROPOSED)
FDA 510(k)
FDA Class 2
·Neurology
INSIGNIA
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·January 11, 2013
INTERSTIM II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·November 24, 2010
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE REHABILITATION EQUIP·Product code CAW·July 2, 2014
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