BEUDAMED
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    VASER Amplifier, VASER 2.2 VASERlipo System, Rx Only, 115/230V - 60/50Hz 300VA The Vaser amplifier is intended for the fragmentation and emulsification of subcutaneous fatty tissues for aesthetic body contouring (modification of the anatomy).

    FDA Recall
    Terminated ·Solta Medical Inc·June 1, 2017

    VASER PRO Amplifier, VASER 2.2 VASERlipo System stem, Rx Only, 115/230V - 60/50Hz 300VA The Vaser amplifier is intended for the fragmentation and emulsification of subcutaneous fatty tissues for aesthetic body contouring (modification of the anatomy).

    FDA Recall
    Terminated ·Solta Medical Inc·June 1, 2017

    SWANSON TRAPEZIUM IMPLANT, Part Number 4520002

    FDA Recall
    Terminated ·Wright Medical Technology, Inc.·Product code KYI·November 8, 2016

    SWANSON FINGER JOINT #1, Part Number 4700001

    FDA Recall
    Terminated ·Wright Medical Technology, Inc.·Product code KYJ·November 8, 2016

    PRO-STIM 10cc INJECTABLE, Part Number 86SR0410

    FDA Recall
    Terminated ·Wright Medical Technology, Inc.·Product code MBP·November 8, 2016

    INBONE STEM, TIBIAL, TOP, Part Number 200011901

    FDA Recall
    Terminated ·Wright Medical Technology, Inc.·Product code HSN·November 8, 2016

    SWANSON FINGER JOINT #2, Part Number 4700002

    FDA Recall
    Terminated ·Wright Medical Technology, Inc.·Product code KYJ·November 8, 2016

    Dart Fire HEADED SCREW 4.0X 32MM, Part Number D1S40032S

    FDA Recall
    Terminated ·Wright Medical Technology, Inc.·Product code HWC·November 8, 2016

    SWANSON GREAT TOE, TITANIUM SZ 4, Part Number 4833104

    FDA Recall
    Terminated ·Wright Medical Technology, Inc.·Product code KWD·November 8, 2016

    Darco STERILE HEADED DRILL BIT 4.4MM , Part Number 777S06514

    FDA Recall
    Terminated ·Wright Medical Technology, Inc.·Product code GFF·November 8, 2016

    EVANS OPENING WEDGE PLATE 10MM, Part Number 58S30010

    FDA Recall
    Terminated ·Wright Medical Technology, Inc.·Product code HRS·November 8, 2016

    CPS CALCANEAL PLATE SML 54MM, Part Number DCS2805001

    FDA Recall
    Terminated ·Wright Medical Technology, Inc.·Product code HRS·November 8, 2016

    VALOR SCREW 5.0MM X 45MM LEN, Part Number 4151150045

    FDA Recall
    Terminated ·Wright Medical Technology, Inc.·Product code HSB·November 8, 2016

    ORTHOLOC 3DI PLT SYS STERILE, LOCKING SCREW, 3.5 x 38mm Sterile, Part Number 58S03538

    FDA Recall
    Terminated ·Wright Medical Technology, Inc.·Product code HWC·November 8, 2016

    TANDEM (TM) COCR SHELL UHMWPE LINER BIPOLAR, REF NUMBERS: 71322040, 71322041, 71322042, 71322043, 71322044, 71322045, 71322046, 71322047, 71322048, 71322049, 71322050, 71322051, 71322052, 71322053, 71322054, 71322055, 71322057

    FDA Recall
    Terminated ·Smith & Nephew, Inc.·Product code KWY·August 29, 2016

    Portex Anaerobic Pulsator Arterial Blood Sampling Kit, with Liquid Sodium Heparin for Gases and Electrolytes. Reorder Number: G1392 Product Usage: The Arterial Blood Sampling Kit is intended for sampling arterial blood for the measurement of blood gasses, Cooximetry, electrolytes, total magnesium, and metabolites, (Glucose and Lactate).

    FDA Recall
    Terminated ·Smiths Medical ASD, Inc.·Product code JKA·December 17, 2014

    TANDEM (TM) INTL COCR SHELL UHMWPE LINER BIPOLAR, REF NUMBERS: 71324038, 71324039, 71324040, 71324041, 71324042, 71324043, 71324044, 71324045, 71324046, 71324047, 71324048, 71324049, 71324050, 71324051, 71324052, 71324053, 71324054, 71324055, 71324057, 71324059, 71325039, 71325040, 71325041,71325042, 71325043, 71325044, 71325045, 71325046, 71325047, 71325048, 71325049, 71325050, 71325051, 71325052, 71325053, 71325054, 71325055, 71325057, 71372047

    FDA Recall
    Terminated ·Smith & Nephew, Inc.·Product code KWY·August 29, 2016

    Sarns TCM; The Sarns Temperature Control and Monitor unit (TCM) is a source of temperature-controlled water for blood heat exchangers used in an extracorporeal circuit and for blankets to externally heat or cool the patient The TCM with options will also supply water for cardioplegia, freeze water for an ice supply, monitor temperatures in the patient and extracorporeal circuit, and allow gradient rewarming relative to a venous blood temperature. Product Usage: The Sarns TCM is indicated for controlling and monitoring patient temperature.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DWC·June 8, 2016

    Sarns TCM II; The Sarns Temperature Control and Monitor unit (TCM) II (system) is a source of temperature controlled water for blood heat exchangers used in an extracorporeal circuit and for blankets to externally heat or cool the patient. It also freezes water for an ice supply, monitors temperatures in the patient and extracorporeal circuit, and allows gradient rewarming relative to a venous blood temperature. Product Usage: The Sarns TCM II is indicated for controlling and monitoring patient temperature.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DWC·June 8, 2016

    Preamendments device-Sarns Dual Cooler-Heater. The Sarns Dual Cooler-Heater is a self-contained unit for supplying cold and warm water to heat exchangers during open heart surgery. It supplies water at a rate of up to 6.5 gallons per minute (25 liters per minute) at zero head, and will provide a maximum pressure output of 11 pounds per square inch (76,000 pascals). The Sarns TM Dual Cooler-Heater can be used with heat exchangers capable of accepting these flows and pressures. Product Usage: The Sarns Dual Cooler-Heater is indicated for use as a water supply system to a blood heat exchanger in open-heart surgery.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DWC·June 8, 2016