BEUDAMED
    17 results · 23ms · Sources: EU EUDAMED, US FDA

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    Biogel PI Micro Indicator Underglove

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    HHM

    FDA UDI
    Oticon A/S·05707131284891·H160V2, RITE 312 WL SGR HHM

    Vilex Guidewire

    FDA UDI
    VILEX IN TENNESSEE, INC.·00841731120526·Guidewire 1.4x150mm Dbl Trocar

    Vilex Guidewire

    FDA UDI
    VILEX IN TENNESSEE, INC.·00841731120533·Guidewire 1.4x150mm Sgl Trocar

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100073·TEMPORAL SPECULUM SOLID BLADES

    Trial Cage 25deg 17S

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215066789·

    EVOLVE EPS ORTHOLOC

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VASCULAR SOLUTIONS D-STAT CLAMP ACCESSORY

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·October 7, 2014

    DUROM ACETABULAR COMPONENT

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code KWA·May 30, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 6, 2011

    MEDTRONIC DUAL CHAMBER TEMPORARY EXTERNAL PACEMAKER 510(K) K150246

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

    POLYMETHYLMETHACRYLATE BONE CEMENT

    FDA Adverse Event
    Injury ·SYNTHES SELZACH·Product code NDN·August 16, 2016

    OT ULTRASMART METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·March 9, 2012

    ProScreen 10 Drug Panel Cassette Test, Item No. CPSP-10PPX; ProScreen 10 Panel Cup, Item No. PSCup-10MMO-300, PSCup-10M, PSCupA-10MO, PSCUp-10AB; ProScreen 10 Panel Cup with Adulterants, Item No. PSCupA-10AM; ProScreen 10 Panel Dip Card, Item No. PSD-10MMO-300, PSD-10MOX, PSD-10M, PSD-10CMO3, PSD-10APO-300; ProScreen 10 Panel Dip Card w/Adult, Item No. PSDA-10MO, PSDA-10MMO-300; ProScreen 11 Panel Dip Card, Item No. PSD-11MT; ProScreen 12 Drug Cup w/Adulteration, Item No. PSCupA-12TBU; ProScreen 12 Panel Cup w/Adult., Item No. PSCupA-12M, PSCupA-12PP; ProScreen 12 Panel Dip Card, Item No. PSD-12BUP ProScreen 5 Panel Dip Card, Item No. PSD-5MB; ProScreen 5 Panel Dip Card w/Adult, Item No. PSDA-5MB-300; ProScreen 6 Panel Cassette w/Adult (AU), Item No. PSPA-6MBAU; ProScreen 6 Panel Cup w/Adult (AU), Item No. PSCupA-6MBAU; ProScreen 6 Panel Dip Card, Item No. PSD-6MBO, PSD-6MTDBO-300, PSD-6MB, PSD-6BUPO; ProScreen 7 Panel Dip Card, Item No. PSD-7MO, PSD-7M; ProScreen 8 Panel Dip Card, Item No. PSD-8P; ProScreen 8 Panel Dip Card w/Adult, Item No. PSDA-8P; ProScreen 9 Panel Dip Card, Item No. PSD-9P; ProScreen CLIA Waived Cup 6 Drugs w/Adul, Item No. PSCupA-6MB-W; ProScreen CLIA Waived Cup with 6 Drugs, Item No. PSCup-6BO-W; ProScreen CLIA Waived Cup with 8 Drug, Item No. PSCup-8P-W; ProScreen Cup, Item No. PSCup-6MB-W, PSCupA-6MB-W, PSCup-6BO-W, PSCup-8P-W, PSCUp-10AB, PSCup-10MMO-300; ProScreen Cup CLIA with 6 Panel Drug, Item No. PSCup-6MB-W; These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use. ¿¿¿

    FDA Enforcement
    Class II ·Terminated·Ameditech Inc·November 25, 2015

    Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty

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

    Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);

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