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

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    Terason uSmart3300 Ultrasound System

    FDA 510(k)
    FDA Class 2 ·Radiology

    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

    Stage-1

    FDA UDI
    KEYSTONE DENTAL, INC.·D768S15014810K0·Tap

    Stage-1

    FDA UDI
    KEYSTONE DENTAL, INC.·D768S15014816K0·Tap

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code NKB·July 21, 2017

    MENTOR ARIS TRANS-OBTURATOR TAPE AND SURGICAL KIT

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

    SIMPLEXA INFLUENZA A H1N1 (2009) MODEL MOL2500

    FDA 510(k)
    FDA Class 2 ·Microbiology

    K-WIRE

    FDA Adverse Event
    Injury ·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code HWC·December 9, 2016

    HIRES 90K IMPLANT

    FDA Adverse Event
    Injury ·ADVANCED BIONICS LLC·Product code MCM·May 30, 2013

    COLLEAGUE PRE P1.7

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

    PLATE, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HRS·October 7, 2014

    MICROVASCULAR PLUG

    FDA Adverse Event
    Injury ·REVERSE MEDICAL·Product code KRD·September 8, 2021

    MICROVASCULAR PLUG

    FDA Adverse Event
    Injury ·REVERSE MEDICAL·Product code KRD·September 8, 2021

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code NKB·April 19, 2019

    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