BEUDAMED
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    PARADIGM SOF-SET ULTIMATE QR, MODELS 317 AND 318

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Implant Prosthetics

    FDA UDI
    Preat Corporation·00842092135051·GCL 3i Certain 5.0mm Engaging Verification Cyli...

    Capstone Control PTC Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00643169679993·SPACER 5001832 CONTROL PTC 6 DEG 18X32

    AirLife™

    FDA UDI
    VYAIRE MEDICAL, INC.·10190752155923·Circuit Hanger

    AirLife™

    FDA UDI
    AIRLIFE·10889483570708·Circuit Hanger

    Implant Prosthetics

    FDA UDI
    Preat Corporation·00842092135273·GCL 3i Certain 5.0mm Engaging Verification Cyli...

    Implant Prosthetics

    FDA UDI
    Preat Corporation·00842092135266·GCL 3i Certain 5.0mm Engaging Verification Cyli...

    Implant Prosthetics

    FDA UDI
    Preat Corporation·00842092135280·GCL 3i Certain 5.0mm Engaging Verification Cyli...

    SMR ECCENT. GLENOSPHERE Ø 36MM

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code KWS·June 29, 2021

    STEROTACTIC LOCALIZATION DEVICE (SLD)

    FDA 510(k)
    FDA Class 2 ·Radiology

    RLP-CHOLESTEROL IMMUNOSEPARATION ASSAY

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    TWIST DRILL

    FDA Adverse Event
    Malfunction ·BIOMET MICROFIXATION·Product code HBE·March 14, 2017

    MITEK VERSALOK TI ANCHOR W/ORTHOCORD

    FDA Adverse Event
    Injury ·DEPUY MITEK·Product code HWC·March 13, 2013

    HT50 VENTILATOR

    FDA Adverse Event
    Other ·NEWPORT MEDICAL INSTRUMENTS, INC.·Product code CBK·February 17, 2011

    EASY LOAD INSERTER

    FDA Adverse Event
    Injury ·BAUSCH & LOMB, INC.·Product code KYB·February 25, 2008

    Arthroscopy Pack, Catalog number 900-1832. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

    FDA Enforcement
    Class I ·Terminated·Customed, Inc·December 10, 2014

    Arthroscopy Pack, Catalog number 900-1832. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

    FDA Recall
    Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code OJH·October 8, 2014

    ARTHROSCOPY PACK- (1) TABLE COVER REINFORCED 50" X 90" (1) PRE PAD WITH CUFF (2) GOWN XL SMS IMPERVIOUS REINFORCED AAMI Ill (1) GOWN IMPERV. EXTRA REINFORCED LGE TNVRAP (1) MAYO STAND COVER REINFORCED (1) TUBE SUCTION CONNECT. X" X 12' (1) STOCKINETTE IMPERVIOUS 14" X 48" (1) U-DRAPE 60" X 70" WITH TAPE SPLIT 6" x 21 " (1) SHEET ARTRHOSCOPY "T" W/POUCH STD SMS (1) SUTURE BAG FLORAL (3) ABSORBENT TOWEL 15" X 20" EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

    FDA Enforcement
    Class I ·Terminated·Customed, Inc·September 10, 2014

    HealthLink***BIOPSY PUNCHES*** Disposable manual instrument for skin biopsy.

    FDA Enforcement
    Class II ·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013

    Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013