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

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    EXACTECH NOVATION CROWN CUP CONSTRAINED LINERS AND RINGS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NA

    FDA UDI
    KEY SURGICAL, INC.·10849771049989·Steinmann Pins, Single trocar, round end, 0.094...

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·24026704293852·

    OMNIPULSE HOLMIUM LASER SYSTEM, OMNIPULSE-MAX HOLMIUM LASER SYSTEM, MODEL 1210, 1210-VHP, 1500-A

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

    VIVAWAVE MICROWAVE SYSTEM

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

    PRECISION NOVI

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·April 22, 2022

    UNK - SCREW

    FDA Adverse Event
    Malfunction ·SYNTHES (USA)·Product code KWQ·July 26, 2011

    UNK - SCREW

    FDA Adverse Event
    Malfunction ·SYNTHES (USA)·Product code KWQ·July 26, 2011

    UNK - SCREW

    FDA Adverse Event
    Malfunction ·SYNTHES (USA)·Product code KWA·July 26, 2011

    UNK - SCREW

    FDA Adverse Event
    Malfunction ·SYNTHES (USA)·Product code KWQ·July 26, 2011

    INSYNC III PACEMAKER

    FDA Adverse Event
    Malfunction ·IPG MFG SWITZERLAND·Product code LWP·April 22, 2013

    STERRAD 200 STERILIZATION SYSTEM

    FDA Adverse Event
    Malfunction ·ADVANCED STERILIZATION PRODUCTS·Product code MLR·July 8, 2008

    ASR ACETABULAR CUPS 48

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·April 15, 2011

    Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 22 mm.

    FDA Enforcement
    Class II ·Terminated·Exactech, Inc.·October 7, 2020

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021