BEUDAMED
    13 results · 21ms · Sources: EU EUDAMED, US FDA

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    PROTEUS PATCH, PROTEUS INGESTIBLE SENSOR (ACCESSORY)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CRYO.S

    FDA UDI
    Greiner Bio - One GmbH·14039943000542·

    Oticon

    FDA UDI
    Oticon A/S·05707131260192·RIA, BTE 13 WL 100 SGR

    CRYO.S

    FDA UDI
    Greiner Bio - One GmbH·14039943002645·

    ENDO GIA SINGLEUSE DUET TRS RELOAD WITH TRI0STAPLE TECHNOLOGY

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    K-TECH 2 POWER TILT SEATING SYSTEM, MODEL K2PT

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    GMK-PRIMARY TIBIAL INSERT STD FIXED SIZE 3 / 10 MM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·October 20, 2021

    NON AC-POWERED PATIENT LIFT

    FDA Adverse Event
    Malfunction ·INVACARE SUZHOU·Product code FSA·May 29, 2013

    SM PLUS BTT/OVAL BALLOON DISSECTOR

    FDA Adverse Event
    Malfunction ·USSC PUERTO RICO·Product code GCJ·May 11, 2011

    CARPENTIER-EDWARDS PERIMOUNT MAGNA AORTIC BIOPROSTHESIS

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code LWR·August 21, 2008

    Azurion 5 M20; System Code: (1)722228, (2)722232, (3) 722281 (OUS only);

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    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

    Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024