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

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    NexGen Option Stemmed Tibial Component Size 6, Item Number 00-5986-047-02

    FDA Recall
    Open, Classified ·Zimmer, Inc.·Product code JWH·December 6, 2022

    NexGen Option Stemmed Tibial Component Size 8, Item Number 00-5986-057-02

    FDA Recall
    Open, Classified ·Zimmer, Inc.·Product code JWH·December 6, 2022

    NexGen Option Stemmed Tibial Component Size 4, Item Number 00-5986-037-02

    FDA Recall
    Open, Classified ·Zimmer, Inc.·Product code JWH·December 6, 2022

    NexGen Option Stemmed Tibial Component Size 7, Item Number 00-5986-057-01

    FDA Recall
    Open, Classified ·Zimmer, Inc.·Product code JWH·December 6, 2022

    NexGen Option Stemmed Tibial Component Size 3, Item Number 00-5986-037-01

    FDA Recall
    Open, Classified ·Zimmer, Inc.·Product code JWH·December 6, 2022

    NexGen Option Stemmed Tibial Component Size 5, Item Number 00-5986-047-01

    FDA Recall
    Open, Classified ·Zimmer, Inc.·Product code JWH·December 6, 2022

    BD MAX PCR Cartridges Catalog #437519, box of 24 cartridges labeled in part:***BD MAX PCR Cartridges, GeneOhm Sciences Canada, Inc. 2555 boul du Parc-Technologique, Quebec, Canada G1P 4S5***BD Max Group B Streptococcus (GBS) Assay is an in vitro diagnostic (IVD) test for detection of GBS DNA in Lim Broth cultures. The BD MAX" PCR Cartridge is a consumable required for the BD MAX" System.

    FDA Recall
    Terminated ·Becton Dickinson & Co. BD Diagnostic Systems·Product code NJR·December 11, 2012

    Xpert Infinity Software, V 4.1a. Cepheid, Sunnyvale, CA 94089 system software for GeneXpert Infinity 48

    FDA Recall
    Terminated ·Cepheid·Product code NJR·April 1, 2011

    Becton, Dickinson and Company, BD MAX (tm) (6 channel) Instruments, Catalog number 441916, clinical diagnostic instrument.

    FDA Recall
    Terminated ·Becton Dickinson & Co. BD Diagnostic Systems·Product code NJR·September 18, 2012

    BD PCR Cartridges used with MAX System. Model Number: 437519

    FDA Recall
    Open, Classified ·Becton Dickinson & Co.·Product code NJR·December 19, 2024

    Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD.

    FDA Recall
    Open, Classified ·Hologic, Inc.·Product code NJR·December 13, 2024

    BD MAX Instrument, catalog #441916 Product Usage: The BD MAX System, used in conjunction with the appropriate extraction kits and reagents is capable of automated amplification and detection of target nucleic acid sequences for use in clinical, industrial, and research settings.

    FDA Recall
    Terminated ·Becton Dickinson & Co. BD Diagnostic Systems·Product code NJR·May 31, 2013

    ARIES GBS Assay , REF 50-10021, UDI # 00840487100165

    FDA Recall
    Open, Classified ·Luminex Corporation·Product code NJR·February 20, 2019

    Cepheid, Xpert GBS Assay Diagnostic Test Kit Part No: GXGBS-100N-10 (in foil pouch) for use with the GeneXpert DX System, Cepheid, Sunnyvale, CA 94089

    FDA Recall
    Terminated ·Cepheid·Product code NJR·September 5, 2007

    Granada Biphasic Broth The product is a selective medium for the screening and identification of Streptococcus agalactiae in pregnant women using clinical specimens.

    FDA Recall
    Terminated ·Biomerieux Inc·Product code NJR·November 23, 2015

    Meridian Bioscience, Group B Streptococcus, Catalog Number 480050, Nucleic Acid Amplification Test Assay

    FDA Recall
    Open, Classified ·Meridian Bioscience Inc·Product code NJR·October 7, 2025

    Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in vitro diagnostic test for group b streptococcus.

    FDA Recall
    Open, Classified ·Hologic, Inc·Product code NJR·March 18, 2022

    7F ZUMA 2 JR 4.0 110CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z27JR40A

    FDA Recall
    Terminated ·Medtronic, Inc.·Product code DQY·April 5, 2006

    Multi-Drug iCup Drug Screen Test Cup. Part Number DUE-1127-022-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG

    FDA Recall
    Terminated ·Biosite Inc·Product code DKZ·April 27, 2009

    Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-1107-012-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG

    FDA Recall
    Terminated ·Biosite Inc·Product code DKZ·April 27, 2009