BEUDAMED
    18 results · 22ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    Hematocrit and Metabolite QUALICHECK

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    AGXO

    FDA UDI
    Oticon A/S·05707131286512·H160V2 TI, MINIRITE 312 WL SGR AGXO

    Tibial Tray Insert Shim 6.0 mm

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215073763·

    WIRELESS BODY TEMPERATURE MONITOR MODEL BTM-DIX SERIES (BTM-DIC,D,E,F,G & H)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ASIAN INTRAMEDULLARY HIP SCREW NAILS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SURESTEP

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·July 9, 2002

    PRECISION SPECTRA

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·September 2, 2020

    PAINSMART IOD

    FDA Adverse Event
    Malfunction ·MOOG DEVICE GROUP·Product code FRN·May 29, 2013

    SECURE 3 MED/SURG BED

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·June 10, 2011

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM

    FDA Adverse Event
    Injury ·BIOENTRICS CORP·Product code LTI·September 3, 2008

    MEDTRONIC DUAL CHAMBER TEMPORARY EXTERNAL PACEMAKER 510(K) K150246

    FDA Adverse Event
    Death ·MEDTRONIC, INC.·Product code DTE·February 10, 2021

    6 Panel Cup Body and Lid w/Adult (AU), Item No. TDDA-6MBAU-CUP

    FDA Enforcement
    Class III ·Terminated·Ameditech Inc·December 30, 2015

    TPRLC 133 MP TYPE1 PPS HO 17.0

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code KWA·January 22, 2020

    TPRLC 133 MP TYPE1 PPS HO 16.0

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code KWA·January 22, 2020

    TPRLC XR MP T1 PPS 15X115MM

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code LPH·January 22, 2020

    TPRLC 133 T1 PPS HO 14X148MM

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code KWA·January 22, 2020

    The recalled product is the Disposable biopsy plate, part #U1-150131. The biopsy plate is labeled in part: Disposable Biopsy Plate, part U1-150131, For Use with the Liberty 9000 8-Channel Breast Coil, USA Instruments, Inc., Aurora, OH, sterile. The breast biopsy plate is used with GE coils and with OEM coils (coils manufactured for Philips and Hitachi by USA Instruments) during Magnetic Resonance breast biopsy procedures. The disposable biopsy plate for use with GE coils is packaged and sold as a part of catalogue U1-160051, U1-150190, U1-150131. The disposable biopsy plate for use with OEM coils is packaged and sold as part of catalogue U1-150226, U1-150190, U1-155068, U1-160016, U1-160052, U1-160085, U1-160166, U1-160175, 2412158, 2416938, 2417842, and U1-150131.

    FDA Recall
    Terminated ·USA Instruments Incorporated·Product code LNH·January 31, 2007

    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