16 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ReTrace Ureteral Access Sheath
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SureCore Automatic Disposable Biopsy Needle
FDA UDI
Canyon Medical Inc.·06954414658972·Automatic Disposable Biopsy Needle
SureCore Automatic Disposable Biopsy Needle
FDA UDI
Canyon Medical Inc.·06954414659269·Automatic Disposable Biopsy Needle
SureCore Automatic Disposable Biopsy Needle
FDA UDI
Canyon Medical Inc.·06954414659108·Automatic Disposable Biopsy Needle
FX V 135 stem
FDA UDI
FX SOLUTIONS·03701037318430·FX V135 LONG STEM TA6V CEMENTLESS Ø32/09 LG180m...
PROTEGRITY SMT LATEX SURGICALGLOVES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
CARE3 PLUS
FDA 510(k)
FDA Class 1
·Dental
LEADSET,5LEAD,EXT,SNAP,24",IEC
FDA UDI
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06944904059396·
PAINSMART IOD
FDA Adverse Event
Malfunction
·MOOG DEVICE GROUP·Product code FRN·June 6, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 27, 2011
GE OEC 6800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 19, 2008
PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code FTL·April 28, 2021
SURESCAN
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·August 24, 2016
MEDTRONIC TRANSCATHETER VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·August 10, 2023
MEDTRONIC SURGICAL TISSUE VALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code LWR·August 10, 2023
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