18 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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FDA 510(k)
FDA Class 2
·Radiology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772777525·LUMBAMED PLUS FLEX PAD M SILVER V
Knot MManipulator, Shoulder
FDA UDI
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION·10818674021958·
SOLUTION SYSTEM
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295087113·SOLUTION SYSTEM THINSHAFT REAMER 18mm DIA
POSI-GRIP UMBILICAL CORD CLAMP, STERILE, MODEL 384, POSI-GRIP UMBILICAL CORD CLAMP, NON-STERILE, MODEL 385
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
GEO MAGIC COLOR (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS
FDA 510(k)
FDA Class 2
·Ophthalmic
SCREW, CORTICAL
FDA Adverse Event
Injury
·ARTHREX INC.·Product code HRS·November 7, 2017
SCREW, CANCELLOUS
FDA Adverse Event
Injury
·ARTHREX INC.·Product code HRS·November 7, 2017
SCREW, CORTICAL
FDA Adverse Event
Injury
·ARTHREX INC.·Product code HRS·November 7, 2017
SCREW, CORTICAL
FDA Adverse Event
Injury
·ARTHREX INC.·Product code HRS·November 7, 2017
SCREW, CORTICAL
FDA Adverse Event
Injury
·ARTHREX INC.·Product code HRS·November 7, 2017
SCREW, CANCELLOUS
FDA Adverse Event
Injury
·ARTHREX INC.·Product code HRS·November 7, 2017
M2A-38 CUP NON FLARED SZ 54MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·October 29, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·August 12, 2011
CONFIENT
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 8, 2013
SCREW, CANCELLOUS
FDA Adverse Event
Injury
·ARTHREX INC.·Product code HRS·November 7, 2017
ARTHRO KNOT MANIP FULL *EA
FDA Adverse Event
Malfunction
·DEPUY MITEK LLC US·Product code HCF·October 25, 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