21 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Elecrtronic Blood Pressure Monitor (BP-201, BP-202, BP-203, BP-204, BP-205, BP-206)
FDA 510(k)
FDA Class 2
·Cardiovascular
Acetabular reamer ø72mm
FDA UDI
Incipio Devices SA·07630055301727·Acetabular reamer for hip arthroplasty
Pro-Link Stand-Alone Cervical Spacer System
FDA UDI
Life Spine, Inc.·00190837013769·
Ti Pro-Link Stand-Alone Cervical System
FDA UDI
Life Spine, Inc.·00190837017729·
Pro-Link Stand-Alone Cervical Spacer System
FDA UDI
Life Spine, Inc.·00190837013776·
Ti Pro-Link Stand-Alone Cervical System
FDA UDI
Life Spine, Inc.·00190837017705·
Pro-Link Stand-Alone Cervical Spacer System
FDA UDI
Life Spine, Inc.·00190837013745·
Ti Pro-Link Stand-Alone Cervical System
FDA UDI
Life Spine, Inc.·00190837017712·
Pro-Link Stand-Alone Cervical Spacer System
FDA UDI
Life Spine, Inc.·00190837013752·
Ti Pro-Link Stand-Alone Cervical System
FDA UDI
Life Spine, Inc.·00190837017699·
GOLDENLINE POWDER-FREE WHITE VINYL PATIENT EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
NOVABONE - AR - RESORBABLE BONE GRAFT SUBSTITUTE
FDA 510(k)
FDA Class 2
·Orthopedic
BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·February 19, 2019
ZENITH AAA ENDOVASCULAR GRAFT ILIAC LEG
FDA Adverse Event
Injury
·COOK, INC.·Product code MIH·November 21, 2008
CORE IMPACTION DRILL
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code DZJ·September 2, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 22, 2013
BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·February 18, 2019
Roadrunner Hydrophilic PC Wire Guide, Guidewire, Global Product Number G18629, G17866
FDA Enforcement
Class II
·Terminated·Cook Inc.·February 12, 2020
Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020. Additional kits produced through February 19, 2020 were included.
FDA Enforcement
Class II
·Terminated·Cardinal Health 200, LLC·February 26, 2020
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