8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
CORDIS MODELS 336A,336B,337A & 334 CARDIAC PACEMAK
FDA 510(k)
FDA Class 3
·Cardiovascular
Eaglewear
FDA UDI
AMERICAN ORTHODONTICS CORPORATION·00190746007989·SAFETY CERVICAL NECK STRAP - EAGLEWEAR ASSORTED...
Braun Thermoscan PRO 6000 Ear Thermometer
FDA 510(k)
FDA Class 2
·General Hospital
SYSTEM 12 X3 ACETABULAR INSERTS; SERIES II X3 ACETABULAR INSERTS
FDA 510(k)
FDA Class 2
·Orthopedic
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 6, 2014
INSIGNIA
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·October 4, 2010
HEARTMATE II LVAS
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·November 30, 2012
Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Concentrate Distribution and Storage) with remote fill is intended to be used in Hemodialysis facilities for the storage and distribution of acid concentrate to be used in the treatment of Hemodialysis patients Model: ACDS MD704262
FDA Enforcement
Class II
·Terminated·Isopure Corp·September 21, 2022