BEUDAMED
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    Tri-Star Surgical Exam Light MR-16 ( Lamp Holder) used in the following: Model Numbers: TS2015W (wall mount) , TS2015M (mobile) , TS2015W (wall mount) , TS2035M (mobile)

    FDA Recall
    Terminated ·Sunnex Inc.·Product code FTA·February 13, 2007

    Sunnex Celestial Star MR-16 (lamp holder) Medical Examination Lighting used in Model Numbers: CS2050C (ceiling mount), CS2050W (wall mount). CS2050D (dual mount) , CS2050M (mobile).

    FDA Recall
    Terminated ·Sunnex Inc.·Product code FTA·February 13, 2007

    Disposable Light Handle Cover, Item Number B1-715-65. Packaged 1 device inside a peel pouch and sealed. Sealed pouches are packaged 10 each inside a poly liner. 5 rows of 10 pouches are placed in a labeled corrugated mailer box. Product Usage: Intended to be used as a disposable barrier for a surgical lighting system and which allows a surgical team member to manually adjust the lighting system. Single use device.

    FDA Recall
    Terminated ·Ecolab, Inc.·Product code FTA·October 13, 2017

    The Red Head 2 Reusable Fat Harvesting Canister, Product # RH-2, Non-Sterile. Intended for use in aspirating subcutaneous fatty tissue in patients desiring aesthetic body contouring and autologous fat collection.

    FDA Recall
    Terminated ·Miami Fat Supply, Inc·Product code MUU·April 21, 2016

    The Red Head 2 Reusable Fat Harvesting Canister, Product # RH-2, Non-Sterile. Intended for use in aspirating subcutaneous fatty tissue in patients desiring aesthetic body contouring and autologous fat collection.

    FDA Enforcement
    Class II ·Terminated·Miami Fat Supply, Inc·June 22, 2016

    Ultra Battery 1 Model: TA-UB1 NSN: 6515-01-592-5803 The Ultra Battery 1 (TA-UB1) is a rechargeable power source for the Thermal Angel Blood and IV Fluid Infusion Warmer. The TA-UB1 battery was designed to provide sufficient power for the Thermal Angel to warm and deliver one liter of blood or IV fluid infusion to a trauma patient.

    FDA Enforcement
    Class II ·Terminated·Estill Medical Technologies, Inc·October 29, 2014

    Atellica CH ¿2-Microglobulin (B2M) -M) Assay for in vitro diagnostic use in the quantitative determination of ¿2-microglobulin in human serum and plasma Siemens Material Number (SMN): 11097635

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·January 5, 2022

    Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Plasma, 18 MM, 55 MM Long Item Number: 113618

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·March 2, 2022

    Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 12 MM, 83 MM Long Item Number: 113632

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·March 2, 2022

    Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Plasma, 11 MM, 55 MM Long Item Number: 113611

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·March 2, 2022

    Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 11 MM, 83 MM Long Item Number: 113631

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·March 2, 2022

    Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 15 MM, 83 MM Long Item Number: 113635

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·March 2, 2022

    Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 13 MM, 83 MM Long Item Number: 113633

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·March 2, 2022

    Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Plasma, 14 MM, 55 MM Long Item Number: 113614

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·March 2, 2022

    Arcos Modular Revision Hip System, Standard Cone Prox Body, Porous Plasma,Size A, 60 MM Item Number: 11-301301

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·March 2, 2022

    SYNCHRON Systems Barbiturates Reagent (BARB 1 X 250); Catalog No. 475012 - Product Usage: BARB reagent, in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON Systems Drugs of Abuse Testing (DAT) Urine Calibrators, is intended for the qualitative determination of barbiturates in human urine at a cutoff value of 200 ng/mL The BARB assay provides a rapid screening procedure for determining the presence of barbiturates (BARB) and its metabolites in urine.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code DIS·June 12, 2019

    ABX Pentra Calcium AS CP, Reagent 90 mL, REF A11A01954

    FDA Enforcement
    Class II ·Terminated·MEDLINE INDUSTRIES, LP - Northfield·June 1, 2022

    (Stryker) AccuPlace Straight Level Needle Guide; Assists the user with inserting a needle at a predetermined angle for computer tomography.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code GDF·February 4, 2016

    (Stryker) AccuPlace Round Level Needle Guide; Assists the user with inserting a needle at a predetermined angle for computer tomography.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code GDF·February 4, 2016

    50001 (Inrad) AccuPlace Drace Stereotaxic Needle Guide; Assists the user with inserting a needle at a predetermined angle for computer tomography.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code GDF·February 4, 2016