BEUDAMED
    34 results · 14ms · Sources: EU EUDAMED, US FDA

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    Bacterin International, Inc., Osteoselect Demineralized Bone Matrix DMB Putty; Graft ID# B090056-664 Donor# B090056 2.5cc Expiration Date: 12/25/2011; LBL 210-0010-1 REV: 040109; and Graft ID# B090056-675. Bone void filler for voids or gaps in bone. Indicated for treatment of surgically created osseous defects. On 07/12/2012 an additional expired product was discovered by a Bacterin sales rep. B100078-908 with expiration date 04/27/2012

    FDA Enforcement
    Class II ·Terminated·Bacterin International, Inc.·February 20, 2013

    JUGGERKNOT 2.9MM 2 #2 MB Product Usage: For use in hip arthroplasty

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·March 21, 2018

    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

    DigitalDiagnost 4.1 High Performance (Stitching Patient Support) 712031

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems Gmbh, DMC·August 29, 2018

    EasyDiagnost Eleva DRF (Stitching Patient Support) 706032

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems Gmbh, DMC·August 29, 2018

    DigitalDiagnost 4 High Performance (Stitching Patient Support) 712027

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems Gmbh, DMC·August 29, 2018

    DigitalDiagnost 4 Chest / Emergency (Stitching Patient Support) 712029

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems Gmbh, DMC·August 29, 2018

    DigitalDiagnost Single Detector (Stitching Patient Support) 712020

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems Gmbh, DMC·August 29, 2018

    CombiDiagnost R90 (Stitching Patient Support) 709030

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems Gmbh, DMC·August 29, 2018

    DigitalDiagnost 2.x Upgrades (Stitching Patient Support) 712082

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems Gmbh, DMC·August 29, 2018

    DigitalDiagnost Classic 1.x Upgrades (Stitching Patient Support) 712081

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems Gmbh, DMC·August 29, 2018

    DigitalDiagnost 4.1 High Performance (Stitching Patient Support) 712031

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems Gmbh, DMC·August 29, 2018

    DigitalDiagnost Dual Detector (Stitching Patient Support) 712022

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems Gmbh, DMC·August 29, 2018

    DigitalDiagnost Release 3 (Stitching Patient Support) 712025

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems Gmbh, DMC·August 29, 2018

    DigitalDiagnost Classic, Dual-Detector (Stitching Patient Support) 712052

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems Gmbh, DMC·August 29, 2018

    DigitalDiagnost, Single-Detect (Stitching Patient Support) 712062

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems Gmbh, DMC·August 29, 2018

    DigitalDiagnost 4 Flex / Value (Stitching Patient Support) 712028

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems Gmbh, DMC·August 29, 2018

    DigitalDiagnost Release 3.1 (Stitching Patient Support) 712026

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems Gmbh, DMC·August 29, 2018

    DigitalDiagnost 2.x Upgrades (Stitching Patient Support) 712081

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems Gmbh, DMC·August 29, 2018

    DigitalDiagnost, Dual-Detector (Stitching Patient Support) 712052

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems Gmbh, DMC·August 29, 2018