BEUDAMED
    172 results · 41ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Status: Terminated ×

    Offset Wire Fixation Bolt, catalog number 8180-50-006. The bolts are used with the DePuy Ace-Fischer External Fixation System and are packaged in a flexible polyethylene bag.

    FDA Recall
    Terminated ·DePuy Orthopaedics, Inc.·Product code HXK·November 8, 2011

    Fischer Cone Biopsy Excisor - Lg - Shallow Model: 900-155

    FDA Recall
    Terminated ·Apple Medical Corporation·Product code HGI·March 10, 2006

    Fischer Cone Biopsy Excisor Model: 900-158

    FDA Recall
    Terminated ·Apple Medical Corporation·Product code HGI·March 10, 2006

    Fischer Cone Biopsy Excisor - Small Model: 900-150

    FDA Recall
    Terminated ·Apple Medical Corporation·Product code HGI·March 10, 2006

    Fischer Cone Biopsy Excisor - Medium Model: 900-151

    FDA Recall
    Terminated ·Apple Medical Corporation·Product code HGI·March 10, 2006

    Fischer Cone Biopsy Excisor - Medium - Ext Model: 900-154

    FDA Recall
    Terminated ·Apple Medical Corporation·Product code HGI·March 10, 2006

    Fischer Cone Biopsy Excisor Model: 900-157

    FDA Recall
    Terminated ·Apple Medical Corporation·Product code HGI·March 10, 2006

    Fischer Cone Biopsy Excisor - Dual Sets Model: 900-156

    FDA Recall
    Terminated ·Apple Medical Corporation·Product code HGI·March 10, 2006

    Fischer Cone Biopsy Excisor - Large Model: 900-152

    FDA Recall
    Terminated ·Apple Medical Corporation·Product code HGI·March 10, 2006

    Fischer Cone Biopsy Excisor, Medium (5/Box); Model Number: 900-151

    FDA Recall
    Terminated ·CooperSurgical, Inc.·Product code HGI·March 12, 2018

    Thermo Fisher Scientific/Microgenics brand CEDIA Tobramycin II Assay, Catalog Number 100018, Product is manufactured and distributed by Microgenics Corporation, located at Fremont, CA., part of Thermo Fisher Scientific The CEDIA Tobramycin II Assay is an in vitro diagnostic medical device intended for the quantitation of Tobramycin in human serum or plasma.

    FDA Enforcement
    Class II ·Terminated·Microgenics Corp·December 25, 2013

    Pacific Hemostasis Thromboplastin-DS, catalog #100354, packaged in 4 mL lypholyzed vials, 10 bottles/carton. Vials are labeled, in part ***Fisher Diagnostics a division of Fisher Scientific Company, LLC Middletown, VA 22645-1905 USA*** Thromboplastin-DS is a Class 2 medical device intended for use in performing the one stage prothrombin time (PT) test and PT-based factor assays.

    FDA Recall
    Terminated ·Fisher Diagnostics, A Company of Fisher Scientific LLC·Product code GJS·October 6, 2010

    Endura MD Mass Spectrometer u using software versions Endura MD Software 1.0 and 1.0 SP1. In vitro diagnostic medical device used to identify and quantify inorganic and organic compounds in the human body. Chemistry: In vitro diagnostic medical device used to identify and quantify inorganic and organic compounds in the human body.

    FDA Enforcement
    Class II ·Terminated·Thermo Finnigan LLC·September 21, 2016

    Thermo Fisher Scientific/Microgenics brand CEDIA Tobramycin II Assay, Catalog Number 100018, Product is manufactured and distributed by Microgenics Corporation, located at Fremont, CA., part of Thermo Fisher Scientific The CEDIA Tobramycin II Assay is an in vitro diagnostic medical device intended for the quantitation of Tobramycin in human serum or plasma.

    FDA Recall
    Terminated ·Microgenics Corp·Product code LFW·October 16, 2013

    Fisher Healthcare Sure-Vue Serum/Urine hCG-STAT; in vitro diagnostic test; Catalog Number: FHC-A202; Product Codes: FHC-A202-KFI3O & FHC-A202-KFI5O; Inverness Medical Professional Diagnostics, San Diego, CA 92121.

    FDA Recall
    Terminated ·Innovacon Inc·Product code JHI·October 1, 2007

    enGen (TM) Laboratory Automation Systems using all TCAutomation(TM) Software Versions with the InOut Communication Interface, IVD

    FDA Enforcement
    Class II ·Terminated·Ortho-Clinical Diagnostics·May 24, 2017

    Fisher & Paykel Healthcare ICON CPAP (continuous positive airway pressure). Models: ICON Auto: ICONAAN, ICONAAN-HT, ICONAAJ. ICON Novo: ICONNAN, ICONNAN-HT, ICONNAJ. ICON Premo: ICONPBN, ICONPBN-HT, ICONPBN-HTC. The ICON CPAP unit is for use on adult patients for the treatment of Obstructive Sleep Apnea (OSA). The device is for use in the home or sleep laboratory. The device is not intended to be used as a life supporting device.

    FDA Recall
    Terminated ·Fisher & Paykel Healthcare, Ltd.·Product code BZD·April 22, 2013

    Fisherbrand Sterile Swabs, Calcium Alginate Fiber Tipped Aluminum Applicator Swab, .025 and .035 in Diameter, all lots, 100 per pack Fisherbrand Sterile Swabs, Calcium Alginate Fiber Tipped Plastic Applicator Swab, all lots, 100 per pack Fisherbrand Sterile Swabs, Calcium Alginate Fiber Tipped Wood Applicator Swab, all lots, 100 and 200 per pack culture collection and industrial surfaces

    FDA Recall
    Terminated ·Fisher Scientific Co·Product code KXG·February 5, 2014

    Pacific Hemostasis FDP Latex Reagent, REF/Model Number 100651, UDI 00845275000870, 1 x 5 mL, IVD; --- Fisher Diagnostics, a division of Fisher Scientific Company, LLC, a part of Thermo Fisher Scientific Inc., Middletown, VA 22645-1905 USA

    FDA Recall
    Terminated ·Fisher Diagnostics·Product code KQJ·May 19, 2017

    Pacific Hemostasis FDP (Fibrinogen Degradation Products) Assay Kit (30 Determinations), REF/Model 100650, UDI 00845275000863, IVD; --- Fisher Diagnostics, a division of Fisher Scientific Company LLC ,a part of Thermo Fisher Scientific Inc., Middletown, VA 22645-1905 USA --- For determination of Fibrinogen Degradation products in serum and urine.

    FDA Recall
    Terminated ·Fisher Diagnostics·Product code KQJ·May 19, 2017