11 results
·
35ms
·
Sources: EU EUDAMED, US FDA
PMT MODEL 1110-5 PMT PERITONEAL CATHETER
FDA 510(k)
FDA Class 2
·Neurology
Arthrex®
FDA UDI
ARTHREX, INC.·00888867047877·LO-PRO SCRW,SS 4.0X 36MMCANCLUS
dentaform®
FDA UDI
DENTAURUM GmbH & Co.KG·J011884036000·dentaform® Band, Tooth 46, Size 36
dentaform®
FDA UDI
DENTAURUM GmbH & Co.KG·J011884036180·dentaform® Band, Tooth 46, Size 36/Roth 18
dentaform®
FDA UDI
DENTAURUM GmbH & Co.KG·J011884036220·dentaform® Band, Tooth 46, Size 36/Roth 22
US 610
FDA 510(k)
FDA Class 2
·Physical Medicine
HEPARIN COATED BALLOON THERMODILU
FDA 510(k)
FDA Class 2
·Cardiovascular
ACCU-CHEK ® SPIRIT COMBO
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LZG·June 19, 2014
V.A.C. THERAPY SYSTEM
FDA Adverse Event
Injury
·KCI USA, INC.·Product code OMP·October 14, 2010
O-ARM 1000 IMAGING SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC. (LITTLETON)·Product code OXO·December 21, 2012
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