BEUDAMED
    193 results · 10ms · Sources: EU EUDAMED, US FDA

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    VIDAS Chlamydia Assay (CHL) for In-Vitro Diagnostic Use Product Number: 30101

    FDA Recall
    Terminated ·bioMerieux·Product code LJC·August 6, 2003

    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library, Model #/Product Code 35700BAX2

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·April 5, 2017

    PERSONA The Personalized Knee System Constrained Posterior Stabilized Tibial Articular Surface Provisional TOP with the following: L 3-5 CD; L 6-9 CD; L 3-5 EF; L 6-9 EF; L 10-11 EF; L 6-9 GH; L 10-12 GH; L 10-12 J; R 3-5 CD; R 6-9 CD; R 3-5 EF; R 6-9 EF; R 10-11 EF; R 6-9 GH; R 10-12 GH; and R 10-12 J.

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code JWH·August 7, 2014

    PERSONA The Personalized Knee System Constrained Posterior Stabilized Tibial Articular Surface Provisional TOP with the following: L 3-5 CD; L 6-9 CD; L 3-5 EF; L 6-9 EF; L 10-11 EF; L 6-9 GH; L 10-12 GH; L 10-12 J; R 3-5 CD; R 6-9 CD; R 3-5 EF; R 6-9 EF; R 10-11 EF; R 6-9 GH; R 10-12 GH; and R 10-12 J.

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·September 10, 2014

    Electrohydraulic lithotripter probe, 1.9 FR 375 cm, Model 9-195-371DS used with a Model 9-201-00 Autolith lithotripter. electrohydraulic lithotripsy (EHL) is a method that allows large stones to be fragmented and removed percutaneously or endoscopically.

    FDA Enforcement
    Class II ·Terminated·Northgate Technologies, Inc.·November 15, 2017

    Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·February 11, 2015

    Electrohydraulic lithotripter probe, 1.9 FR 375 cm, Model 9-195-371DS used with a Model 9-201-00 Autolith lithotripter. electrohydraulic lithotripsy (EHL) is a method that allows large stones to be fragmented and removed percutaneously or endoscopically.

    FDA Recall
    Terminated ·Northgate Technologies, Inc.·Product code FFK·May 24, 2017

    Product is packed in a pouch which is labeled as MicroChoice FOOTSWITCH Linvatec LINVATEC CORPORATION LARGO, FL 33773 USA 5020-053

    FDA Recall
    Terminated ·Linvatec Corp DBA Linvatec/Hal·Product code HWE·January 24, 2003

    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library, Model #/Product Code 35700BAX2

    FDA Recall
    Terminated ·Baxter Healthcare Corporation·Product code FRN·January 26, 2017

    DeVilbiss Model DV5x Series CPAP with Heated Humidifier Device is intended to treat Obstructive Sleep Apnea (OSA) in patients weighing 30 Kg and above. The device creates a positive pressure in the patient's airway to prevent collapse of the airway while the patient is sleeping. The heated humidifier provides additional humidity to the air supplied to the patient. The heated humidifier has a removable water chamber for filling with water and ease of cleaning.

    FDA Recall
    Terminated ·Sunrise Medical HHG Inc. dba DeVilbiss Healthcare·Product code BZD·March 11, 2011

    Anti-Cardiolipin IgA ELISA test kit. Product is manufactured by Zeus Scientific, Branchburg, NJ for Sigma Diagnostics, Inc., Saint Louis, MO.

    FDA Recall
    Terminated ·Zeus Scientific Inc·Product code MID·June 22, 2001

    Rheumatoid Factor ELISA Test Kit. Labeled under the following names: Sigma Diagnostics, Inc, Saint Louis, MO and Zeus Scientific, Inc Branchburg, NJ.

    FDA Recall
    Terminated ·Zeus Scientific Inc·Product code DHR·November 9, 2001

    Rubella IgM ELISA Test Kit. It is an enzyme-linked immunoabsorbent assay designed for the qualitative detection of IgM antibodies to Rubella virus in human serum. 1 kit (96 tests). Prepared for Sigma Diagnostics, Inc., St. Louis, MO 63178. EIA514-B

    FDA Recall
    Terminated ·Zeus Scientific Inc·Product code LFX·February 24, 2000

    Measles (Rubeola) IgG ELISA Test System. It is an enzyme-linked immunosorbent assay (ELISA) designed for the qualitative detection of IgG antibodies to Measles (Rubeola) virus in human serum and is for in vitro diagnostic use. Product Number: 507055

    FDA Recall
    Terminated ·Zeus Scientific Inc·Product code LJB·March 19, 2001

    Apollo EZ; Model: 9784152036 Product Usage: General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures

    FDA Recall
    Terminated ·Villa Sistemi Medicali S.P.A. Via delle Azalee·Product code KXJ·December 27, 2016

    Alsius CoolGard Temperature Regulation System

    FDA Recall
    Terminated ·Alsius Corporation·Product code NCX·November 9, 2005

    Juno DRF; Model: 709020 Product Usage: General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures

    FDA Recall
    Terminated ·Villa Sistemi Medicali S.P.A. Via delle Azalee·Product code KXJ·December 27, 2016

    Apollo DRF; Model: 9784220831 Product Usage: General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures

    FDA Recall
    Terminated ·Villa Sistemi Medicali S.P.A. Via delle Azalee·Product code KXJ·December 27, 2016

    Apollo; Models: 9784000131 9784000231 9784020131 9784020231 9784100231 9784120131 9784120231 9784130131 Product Usage: General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures.

    FDA Recall
    Terminated ·Villa Sistemi Medicali S.P.A. Via delle Azalee·Product code KXJ·December 27, 2016

    Alsius Cool Line Catheter, Model CL-2295AE

    FDA Recall
    Terminated ·Alsius Corporation·Product code NCX·January 1, 2007