10 results
·
17ms
·
Sources: EU EUDAMED, US FDA
GIBECK WARMBAG REUSABLE CONVECTIVE WARMING BLANKET
FDA 510(k)
FDA Class 2
·Cardiovascular
Nexxis
FDA UDI
Barco NV·05415334002067·NEXXIS SYSTEM ST KIT 1
P.F.C. SIGMA
FDA UDI
DEPUY (IRELAND)·10603295232971·P.F.C. SIGMA TIBIAL INSERT FIXED BEARING TC3 2 ...
Naya Breast Pump System
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Ulike Reglow Light Therapy Device (UM10)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OXIMAX N-560 PULSE OXIMETER
FDA Adverse Event
Malfunction
·NELLCOR PURITAN BENNETT·Product code DQA·January 24, 2013
MAXCEM ELITE
FDA Adverse Event
Injury
·KERR CORPORATION·Product code EMA·January 13, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·July 28, 2014
Depuy P.F.C. E knee system, TC3 tibial insert; polyethylene tibial insert, Sz 2, 12.5 mm; Ref 96-0511.
FDA Recall
Terminated
·Depuy Orthopaedics, Inc.·Product code NJL·May 26, 2005
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