16 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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1417WGC_127um and 1417WGC_140um
FDA 510(k)
FDA Class 2
·Radiology
BENCO
FDA UDI
BENCO DENTAL SUPPLY CO.·00366975051004·
BABYLANCE HEEL INCISION DEVICE , MODELS BLP50, BLP200, BLN50, BLN200
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEPUY LPS DIAPHYSEAL AND METAPHYSEAL SLEEVES
FDA 510(k)
FDA Class 2
·Orthopedic
GLIDEWIRE GT
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQX·March 30, 2026
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 15, 2013
TELIGEN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 21, 2011
PROLIEVE THERMODILITATION KIT
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code MEQ·September 17, 2008
GLIDEWIRE GT
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQX·May 29, 2026
COOK CELECT PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code DTK·December 14, 2020
PENUMBRA COIL 400
FDA Adverse Event
Injury
·PENUMBRA, INC.·Product code HCG·November 29, 2016
RADIFOCUS GLIDEWIRE
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQX·November 26, 2025
TERUMO RADIFOCUS GUIDE WIRE
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DQX·July 3, 2025
GLIDEWIRE GT
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQX·February 21, 2018
CADD-Solis VIP ambulatory infusion pump, Model Numbers: a. 21-2120-0105-02L b. 21-2120-0105-03L c. 21-2120-0105-06L d. 21-2120-0105-07L e. 21-2120-0105-08L f. 21-2120-0105-12L g. 21-2120-0105-13L h. 21-2120-0105-14L i. 21-2120-0105-15L j. 21-2120-0105-17L k. 21-2120-0105-50L l. 21-2127-0105-02L m. 21-2127-0105-06L n. 21-2127-0105-50L
FDA Enforcement
Class I
·Terminated·Smiths Medical ASD Inc.·October 27, 2021
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