10 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PARAPAC
FDA 510(k)
FDA Class 2
·Anesthesiology
P.F.C. SIGMA
FDA UDI
DEPUY (IRELAND)·10603295233015·P.F.C. SIGMA TIBIAL INSERT FIXED BEARING TC3 2 ...
Eye Shield
FDA UDI
KATENA PRODUCTS, INC.·00841668111147·FOX EYE SHIELD W/ GARTER PED PACK OF 50
DEPUY PFC SIGMA KNEE PROSTHESIS
FDA 510(k)
FDA Class 2
·Orthopedic
PS2 Knee System
FDA 510(k)
FDA Class 2
·Orthopedic
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·February 14, 2013
SOFTCLIX® LANCET DEVICE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·January 13, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 28, 2014
Depuy P.F.C. E knee system, TC3 tibial insert; polyethylene tibial insert, Sz 2, 22.5 mm; Ref 96-0515.
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