BEUDAMED
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    rHead Stem Implant 6mm Collar, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

    FDA Enforcement
    Class II ·Terminated·Howmedica Osteonics Corp.·August 15, 2018

    VITROS 5,1 FS Chemistry System, Catalog Number/Product Code 6801375, Unique Device Identifier No. 10758750001132, and VITROS 5,1 FS Chemistry System Refurbished, Catalog Number/Product Code 6801890, Unique Device Identifier No. 10758750001644. Intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code JJE·September 10, 2015

    Software Version 2.8 & Below on VITROS 5,1 FS Chemistry Systems, Catalog Number 6801375, Global Trade Item Number 10758750001132, and VITROS 5,1 FS Chemistry System Refurbished, Catalog Number 6801890, Global Trade Item Number 10758750001644; IVD. Intended for use in the in vitro quantitative, semi quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products MicroSlides and VITROS Chemistry Products MicroTip Reagents.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code JJE·March 10, 2015

    Carepak Sheer Adhesive Bandages 50 Sterile Bandages Assorted Sizes

    FDA Recall
    Terminated ·ASO, LLC·Product code KGX·June 10, 2015

    CATARACT PACK 6/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate

    FDA Recall
    Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code OJK·July 10, 2015

    LAPAROTOMY PACK 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate

    FDA Recall
    Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code LRO·July 10, 2015

    CURATION KIT 10/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate

    FDA Recall
    Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code FMH·July 10, 2015

    TUMMY TUCK PACK-FJG 6/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .

    FDA Recall
    Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code LRO·July 10, 2015

    E.N.T. PK 7/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .

    FDA Recall
    Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code OGR·July 10, 2015

    LAP-CHOLECYSTECTOMY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .

    FDA Recall
    Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code FDE·July 10, 2015

    IMPLANTE DE ORTHOPEDIA 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .

    FDA Recall
    Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code OJH·July 10, 2015

    MINOR PROCEDURE PACK 40/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .

    FDA Recall
    Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code LRO·July 10, 2015

    ANGIOGRAPHY PACK CUSTOMED 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .

    FDA Recall
    Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code OEQ·July 10, 2015

    LAPAROSCOPY-COLORECTAL SURGICAL PACK 2/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .

    FDA Recall
    Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code FDE·July 10, 2015

    OPEN HEART TRAY CUSTOMED 1/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .

    FDA Recall
    Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code OFA·July 10, 2015

    SHOULDER PACK 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .

    FDA Recall
    Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code OJH·July 10, 2015

    CYSTO TUR PACK 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .

    FDA Recall
    Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code FAJ·July 10, 2015

    PREMIUM LAPAROTOMY PK CUSTOMED 6/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .

    FDA Recall
    Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code LRO·July 10, 2015

    TRACHEOTOMY CARE KIT CUSTOMED 50/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .

    FDA Recall
    Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code NXA·July 10, 2015

    WOUND MANAGEMENT CUSTOMED 20/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .

    FDA Recall
    Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code LRO·July 10, 2015