16 results
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18ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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B-D LOSS OF RESISTANCE SYRINGE
FDA 510(k)
FDA Class 2
·Anesthesiology
BD Epilor Syringe BD Franklin Lakes, NJ 07417 BD EDC Laagstraat 57, B-9140 Temse-Belgium The Epilor syringe is used in conjunction with an epidural needle with the purpose of finding the epidural space.
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Company·October 2, 2013
PORT ACCESS NEEDLE
FDA 510(k)
FDA Class 2
·General Hospital
MODIFICATION OF SARNS TWO STAGE VENOUS CANNULA
FDA 510(k)
FDA Class 2
·Cardiovascular
NA
FDA UDI
STERILMED, INC.·10888551007580·SAW BLADE SAGITTAL K9 K2000 SERIES
NA
FDA UDI
STERILMED, INC.·10888551007573·SAW BLADE SAGITTAL FLARED K9 K2000 SERIES
NA
FDA UDI
STERILMED, INC.·10888551007559·SAW BLADE SAGITTAL K9 K2000 SERIES
NA
FDA UDI
STERILMED, INC.·10888551007566·SAW BLADE SAGITTAL K9 K2000 SERIES
NA
FDA UDI
STERILMED, INC.·10888551007603·SAW BLADE SAGITTAL K9 K2000 SERIES
NA
FDA UDI
STERILMED, INC.·10888551007597·SAW BLADE SAGITTAL K9 K2000 SERIES
LAPRO-CLIP
FDA Adverse Event
Malfunction
·COVIDIEN LP LLC NORTH HAVEN·Product code GCJ·June 4, 2025
SPACEMAKER BLUNT TIP TROCAR 10MM
FDA Adverse Event
Malfunction
·USSC PUERTO RICO·Product code GCJ·November 23, 2010
PRECISION®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·January 22, 2013
QUARTET
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code OJX·July 10, 2014
ABC HANDPIECE LAPAROSCOPIC
FDA Adverse Event
Malfunction
·CONSOLIDATED MEDICAL EQUIPMENT·Product code HAM·February 19, 2019
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