BEUDAMED
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    Viral Transport Medium, 3ml, Ref: R99, Container type: Tube, Packaged: 20 tubes/box, IVD, CVM Transport Media is provided in plastic centrifuge tubes and is used for the collection and transport of clinical specimens for the recovery of viral agents

    FDA Enforcement
    Class II ·Terminated·Hardy Diagnostics·December 30, 2020

    Sterile Custom Packs to be used in surgical procedures.

    FDA Enforcement
    Class II ·Terminated·American Contract Systems·June 10, 2020

    Kit BD Max ExK DNA 1 EU LUO; Catalog # 442818

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·August 28, 2019

    Kit BD Max ExK DNA 1 USA; Catalog # 442817

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·August 28, 2019

    Sterile Custom Packs to be used in surgical procedures.

    FDA Enforcement
    Class II ·Terminated·American Contract Systems·June 10, 2020

    Inspire 8 Integrated Phisio OXY w/ HVR Reservoir, Sterile EO, Catalog # 050714 The intended uses for the two elements that constitute the oxygenator/reservoir integrated devices are: INSPIRE 8M Hollow Fiber Oxygenator: The INSPIRE 8M is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It provides gas exchange support and blood temperature control. The INSPIRE 8M is intended to be used for 6 hours or less. INSPIRE HVR (Hardshell Venous/Cardiotomy Reservoir): The INSPIRE HVR is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It collects, de-foams and filters venous blood and suction blood. INSPIRE HVR can be used post-operatively for chest drainage. The INSPIRE HVR is intended to be used for 6 hours or less.

    FDA Enforcement
    Class II ·Terminated·LivaNova USA·May 30, 2018

    Streamline MIS Navigation System Taps, Catalog numbers 04-CANNDRILL-MDN 04-CANNTAP-40-MDN 04-CANNTAP-45-MDN 04-CANNTAP-55-MDN 04-CANNTAP-65-MDN 04-CANNTAP-75-MDN 04-CANNTAP-85-MDN 04-CTAP-TT-65-MDN 04-S-FINDER-MDN 05-SCREWINS-CL-MDN 05-SIMPDRIVER-MDN

    FDA Recall
    Terminated ·RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)·Product code OLO·September 11, 2020

    3/8X3/8X3/8 Y CONN, STRL REF/ GTIN for Insert Label:EC2105S/ 00803622129285

    FDA Recall
    Terminated ·LivaNova USA Inc.·Product code DTL·April 24, 2020

    AngioDynamics NanoKnife Disposable Single Electrode Probes, Irreversible Electroporation (IRE) Device, 15 cm IRE Single Electrode RFID Activation, PG. Catalog No. 20400103

    FDA Recall
    Terminated ·Angiodynamics, Inc.·Product code OAB·April 24, 2020

    Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 22 mm.

    FDA Recall
    Terminated ·Exactech, Inc.·Product code PHX·August 24, 2020

    Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 18 mm.

    FDA Recall
    Terminated ·Exactech, Inc.·Product code PHX·August 24, 2020

    1/4X3/16X3/16YCONN,STRL REF/ GTIN for Insert Label:EC2102S/ 00803622129278

    FDA Recall
    Terminated ·LivaNova USA Inc.·Product code DTL·April 24, 2020

    1/4X3/8 REDUC CONN, STRL REF/ GTIN for Insert Label:EC2140S/ 00803622129315

    FDA Recall
    Terminated ·LivaNova USA Inc.·Product code DTL·April 24, 2020

    1/2 - 3/8 REDUC CONN, STRL REF/ GTIN for Insert Label:EC2145S/ 00803622129322

    FDA Recall
    Terminated ·LivaNova USA Inc.·Product code DTL·April 24, 2020

    3/8 STR CONN, STRL REF/ GTIN for Insert Label:EC2130S/ 00803622129292

    FDA Recall
    Terminated ·LivaNova USA Inc.·Product code DTL·April 24, 2020

    Sterile Disposable Connectors ASY CONN REDUCER 1/2 X 3/8 24 REF/ GTIN for Insert label:050518000/ 00803622123283

    FDA Recall
    Terminated ·LivaNova USA Inc.·Product code DTL·April 24, 2020

    Sterile Disposable Connectors ASY STR CONN 3/16 STRLE 24. REF/ GTIN for Insert Label:050503000/ 00803622123214

    FDA Recall
    Terminated ·LivaNova USA Inc.·Product code DTL·April 24, 2020

    Sterile Disposable Connectors ASY 1/2 CONN W/LL STRLE 24 REF/ GTIN for Insert Label:050608000/ 00803622123382

    FDA Recall
    Terminated ·LivaNova USA Inc.·Product code DTL·April 24, 2020

    Sterile Disposable Connectors ASY 1/4 X 3/8 REDUCER W/LL 24. REF/ GTIN for Insert Label:050434000/ 00803622123207

    FDA Recall
    Terminated ·LivaNova USA Inc.·Product code DTL·April 24, 2020

    Sterile Disposable Connectors ASY STR CONN 1/4 STRLE 24. REF/ GTIN for Insert Label:050504000/ 00803622123221

    FDA Recall
    Terminated ·LivaNova USA Inc.·Product code DTL·April 24, 2020