10 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FASTAK SUTURE ANCHOR
FDA 510(k)
FDA Class 2
·Orthopedic
P.F.C. SIGMA
FDA UDI
DEPUY (IRELAND)·10603295233022·P.F.C. SIGMA TIBIAL INSERT FIXED BEARING TC3 2 ...
PRINCETON
FDA UDI
Princeton Medical Group, Inc.·00810158217744·RETRACTOR OBWEGESER FOR MOUTH JAW FACE CURVED D...
ELLIPSE 12PL, MODEL 9ESL7228
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Universal Cylinder Applicator Family, Universal Segmented Cylinder Applicator Set, Universal Stump Applicator Set, Universal Cervix Probe Set, odd lengths, Universal Cervix Probe Set, even lengths
FDA 510(k)
FDA Class 2
·Radiology
2520274-2013-10229
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code MNI·February 11, 2013
ACCU-CHEK ® AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·January 13, 2011
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·July 28, 2014
Depuy P.F.C. E knee system, TC3 tibial insert; polyethylene tibial insert, Sz 2, 25.0 mm; Ref 96-0516.
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