BEUDAMED
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    Maxi Move Patient Lift with Scale; Manufactured by Arjo Hospital Equipment AB, Eslov, Sweden; Model KMBB4OSU2FUS

    FDA Recall
    Terminated ·Arjo, Inc.·Product code FSG·January 5, 2007

    Maxi Move Patient Lift with Scale; Manufactured by Arjo Hospital Equipment AB, Eslov, Sweden; Model KMBB4MSU2FUS

    FDA Recall
    Terminated ·Arjo, Inc.·Product code FSG·January 5, 2007

    Maxi Move Patient Lift with Scale; Manufactured by Arjo Hospital Equipment AB, Eslov, Sweden; Model KMBB4OLU2FUS

    FDA Recall
    Terminated ·Arjo, Inc.·Product code FSG·January 5, 2007

    Maxi Move Patient Lift with Scale; Manufactured by Arjo Hospital Equipment AB, Eslov, Sweden; Model KMBB4ELU2FUS

    FDA Recall
    Terminated ·Arjo, Inc.·Product code FSG·January 5, 2007

    Vysis LSI ATM/p53: D13S319 /CEP 12/13q34 DNA Probe Set; fluorescence in situ hybridization (FISH) analyte specific reagents, in vitro diagnostic; Abbott Molecular Inc., Des Plaines, IL 60018 USA; list 05J83-001; The probe set consists of a 200 microliter vial of Vysis LSI D13S319 SO/LSI 13q34 SA/CEP 12 SG Probe, reference 30-191024, and a 200 microliter vial of Vysis LSI ATM SG/p 53 SO Probe, reference 30-191025.

    FDA Recall
    Terminated ·Abbott Molecular·Product code MVU·December 22, 2006

    Thomas Medical Products Safesheath CSG (Coronary Sinus Guide) Hemostatic Tear away Introducer System with Infusion Side Port, for the introduction of various types of pacing or defibrillator leads and catheters. The product is shipped 5 per carton. Product is distributed by Pressure Products. Catalog numbers: CSG/MSP-00-09, CSG/90-09, CSG-KR-90-09, CSG/WORLEY-1-09, CSG-WORLEY-Bcor-1-09, CSG/WORLEY/L/Bcor-1-09, CSG/WORLEY-2-09, CSG/WORLEY/Bcor-2-09, CSGMSP0009M, CSGWORLEY109M, CSGWORL19M, CSGWORBC19M, CSGWORLBC19M, CSGWORBC29M, CSG/Worley/BCor-1-07, CSG/Worley/BCor-2-07, CSG/WORLEY/BCOR-M-09, and CSG/Worley/R-1-09.

    FDA Recall
    Terminated ·Thomas Medical Products Inc·Product code DYB·December 17, 2009

    SafeSheath CSG (Coronary Sinus Guide) Worley-1-09 STD; CSG (Coronary Sinus Guide) Worley/BCor/-1-09; CSG (Coronary Sinus Guide)-2-09 Jumbo; CSG (Coronary Sinus Guide)/BCor/-2-09; CSG (Coronary Sinus Guide) Worley/L-1-09 Long; and CSG (Coronary Sinus Guide) Worley/L/BCor-1-09/Long.

    FDA Recall
    Terminated ·Thomas Medical Products Inc·Product code DYB·June 11, 2004

    The CEP 8 SpectrumGreen (SG) ASR Probe Kit, 20ul (list 06J37-018) is an Analyte Specific Reagent (ASR) containing a single vial of CEP 8 spectrum green probe and a Certificate of Analysis (COA). Chromosome enumeration probes (CEP) are chromosome-specific FISH probes that hybridize to highly repetitive human satellite DNA sequences, usually located near centromeres. CEP signals enable the identification and enumeration of human chromosomes in interphase and metaphase cells from fresh and archived samples. The label for CEP 8 SG ASR Probe Kit indicates it is an Analyte Specific Reagent, and analytical and performance characteristics are not established.

    FDA Recall
    Terminated ·Abbott Molecular·Product code MVU·March 28, 2013

    SafeSheath CSG (Coronary Sheath Guide) Multisite (MSP)-00-6.5 and CSG (Coronary Sheath Guide) Multisite-00.09

    FDA Recall
    Terminated ·Thomas Medical Products Inc·Product code DYB·June 11, 2004

    Safe Sheath CSG (Coronary Sinus Guide)-90.09; CSG (Coronary Sinus Guide)/BCor-90/09. These sheaths packaged in 5 individual boxed kits per case carton.

    FDA Recall
    Terminated ·Thomas Medical Products Inc·Product code DYB·June 11, 2004

    SafeSheath CSG (Coronary Sinus Guide) KR-90.09 and CSG (Coronary Sinus Guide) KR/BCor-90.09. These sheaths are packaged in 5 individual boxed kits per case carton.

    FDA Recall
    Terminated ·Thomas Medical Products Inc·Product code DYB·June 11, 2004

    The CEP 8 SpectrumGreen (SG) ASR Probe Kit, 20ul (list 06J37-018) is an Analyte Specific Reagent (ASR) containing a single vial of CEP 8 spectrum green probe and a Certificate of Analysis (COA). Chromosome enumeration probes (CEP) are chromosome-specific FISH probes that hybridize to highly repetitive human satellite DNA sequences, usually located near centromeres. CEP signals enable the identification and enumeration of human chromosomes in interphase and metaphase cells from fresh and archived samples. The label for CEP 8 SG ASR Probe Kit indicates it is an Analyte Specific Reagent, and analytical and performance characteristics are not established.

    FDA Enforcement
    Class III ·Terminated·Abbott Molecular·April 30, 2014

    SafeSheath(R) CSG(R) Coronary Sinus guide Braided Core Hemostatic Introducer, SafeSheath(R) Worley Telescopic Braided Series, and Situs LDS2 Lead Delivery System - Catalog numbers: CSG/WORLEY/BCor-1-09; CSG/WORLEY/BCor-2-09; CSG/WROLEY/L/BCor-1-09; CSG/Worley/R-1-09; CSGWORBC10M; CSGWORBC29M; CSGWORLBC19M; LVI/66-5.5-CR; LVI/66-5.5-RE; LVI/75-5-62-07-HO; LVI/75-5-62-07-HS; LVI/75-5-62-07-MP; LVI/75-5-62-07-RE; LVI/75-5-66-5.5-RE; LVI/Tele/B-60-07-HO; LVI/Tele/B-60-07-HS; LVI/Tele/B-60-07-MP; LVI/Tele/B-60-07-RE; RL065; RL066; RL067; and RL068 This device is intended to be used for the introduction of various types of pacing or defibrillator leads and catheters.

    FDA Recall
    Terminated ·Thomas Medical Products Inc·Product code DYB·October 7, 2011

    Amplatz Stiff Wire Guide

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

    Amplatz Ultra Stiff Wire Guide

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

    SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient Data Module)

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·January 15, 2014

    CryoPatch SG Pulmonary Hemi-Artery, 1 graft

    FDA Enforcement
    Class II ·Terminated·CryoLife, Inc.·October 24, 2018

    SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient Data Module)

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code MHX·December 16, 2013

    Flexichamber Anti-Static Valved Collapsible Holding Chamber, used by patients to administer aerosolized medication from most pressurized Metered Dose Inhalers(pMDIs).

    FDA Enforcement
    Class II ·Terminated·FSC Laboratories, Inc·June 22, 2016

    Flexichamber Anti-Static Valved Collapsible Holding Chamber, used by patients to administer aerosolized medication from most pressurized Metered Dose Inhalers(pMDIs).

    FDA Recall
    Terminated ·FSC Laboratories, Inc·Product code NVP·May 16, 2016