BEUDAMED
    19 results · 28ms · Sources: EU EUDAMED, US FDA

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    Apex Medical Corp. iCH CPAP with PVA 9S-007XXX Series

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Bard® Leg Bag Holders

    FDA UDI
    C. R. Bard, Inc.·00801741127625·Bard® Leg Bag Holders

    Vilex Guidewire

    FDA UDI
    VILEX IN TENNESSEE, INC.·00841731120496·Guidewire 1.1x150mm Sgl Trocar

    Vilex Guidewire

    FDA UDI
    VILEX IN TENNESSEE, INC.·00841731120472·Guidewire 1.1x150mm Dbl Trocar

    Accent Buccal Tube

    FDA UDI
    ORMCO CORPORATION·00889989053876·ACCENT B/T 5SGL 2ND NDX -10TX22 UL

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306819933·Punch, Axial Handle, 5mm shaft, 15cm working le...

    BD CTGCTV2 FOR BD MAX¿ SYSTEM

    FDA Adverse Event
    Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code LSL·April 10, 2025

    BD CTGCTV2 FOR BD MAX¿ SYSTEM

    FDA Adverse Event
    Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code LSL·April 10, 2025

    BD CTGCTV2 FOR BD MAX¿ SYSTEM

    FDA Adverse Event
    Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code LSL·April 10, 2025

    NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SMARXT BMR 1900 CLOSED VENOUS RESERVOIR BAG

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code HRS·April 4, 2023

    VANGUARD BREAST MRI AUXILIARY TABLE WITH 8CH

    FDA Adverse Event
    Other ·SENTINELLE MEDICAL·Product code MOS·June 4, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 5, 2011

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code LZG·August 29, 2008

    Medtronic Sofamor Danek Bone fragmentor Ref Number/Model # 9150111

    FDA Recall
    Terminated ·Medtronic Sofamor Danek USA Inc·Product code LYS·October 20, 2006

    UNIVERSAL CHUCK WITH T-HANDLE

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code LXH·June 18, 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