17 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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1717SCC_127um and 1717SCC_140um
FDA 510(k)
FDA Class 2
·Radiology
Jaeger
FDA UDI
Jaeger Medical GmbH·04250892905280·MasterScreen Pneumo
Jaeger
FDA UDI
Jaeger Medical GmbH·04250892900360·MasterScreen Pneumo
NC/RC Coping for screw-retained abutment
FDA UDI
BIO CONCEPT Co., Ltd.·06947600303572·
DD tempMED
FDA UDI
Dental Direkt GmbH·EDDIK114201·DD tempMED are pre-colored dental milling blank...
Ophthalmic Ring
FDA UDI
KATENA PRODUCTS, INC.·00841668100752·FLIERINGA FIXATION RING 14MM
GC FUJI TEMP
FDA 510(k)
FDA Class 2
·Dental
CHAMELEON FIXATION SYSTEM
FDA 510(k)
FDA Unclassified
·Unknown
VC10 PUMP, 115V
FDA Adverse Event
Malfunction
·GYRUS ACMI, INC.·Product code HHK·January 2, 2025
INCORPORATE
FDA UDI
SPINAL ELEMENTS·00840606151856·17 X 14 CERVICAL TRIALS 20MM 0° LORDOSIS
INCORPORATE
FDA UDI
SPINAL ELEMENTS·00840606152044·17 X 14 CERVICAL TRIALS 20MM 10° LORDOSIS
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 15, 2013
HUDSON NEONATAL DUAL HEATED LIMB CIRCUIT
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code BZO·June 29, 2011
RESOLUTION CLIP DEVICE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code MND·September 17, 2008
RING TRANSJUGULAR INTRAHEPATIC ACCESS SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·November 15, 2019
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