13 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SUPRAMID SUTURE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Mini Sprint ®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR79316131·Mini Sprint II Bracket FACE Evolution II System...
Mini Sprint ®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR79316130051·Mini Sprint II Bracket FACE Evolution II System...
Mini Sprint ®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR79316130101·Mini Sprint II Bracket FACE Evolution II System...
Mini Sprint ®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR79316131001·Mini Sprint II Bracket FACE Evolution II System...
MAGIC TM 125I T3 UPTAKE RADIOASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Intense pulsed light device, Model(s): DE01A-B, DE01A-G, DE01B-B, DE01B-G, DE01C-B, DE01C-G, DE02A-B, DE02A-G, DE02B-B, DE02B-G, DE02C-B, DE02C-G.
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
FOUNDATION KNEE
FDA Adverse Event
Other
·ENCORE MEDICAL, L.P.·Product code JWH·January 22, 2013
COMBISET WITH BVM
FDA Adverse Event
Malfunction
·REYNOSA MANUFACTURING·Product code FJK·November 22, 2010
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·July 14, 2014
CONNECTOR, 1/4" X 1/4" STRAIGHT WITH LUER LOCK PORT
FDA Adverse Event
Malfunction
·SORIN GROUP USA·Product code OEZ·April 26, 2016
Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 35700BAXL Product Usage: The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the controlled administration of fluids. These fluids may includes pharmaceutical drugs, blood, blood products and mixture if required patient therapy. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, intrathecal, epidural or irrigation of fluids. Spectrum infusion pump is intended to be used in conjunction with legally marketed intravenous administration sets and medications provided by user. The Spectrum and Spectrum with MAster Drug Library is intended to reduce operator interaction through automated programming thereby helping to reduce errors associated with complex device programming.
FDA Enforcement
Class II
·Terminated·Baxter Healthcare Corporation·May 16, 2018
Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012