BEUDAMED
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    SMITH & NEPHEW CONTROL DIGITAL OPERATING ROOM SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    SOLIDEA

    FDA UDI
    CALZIFICIO PINELLI SRL·08300496050209·RED WELLNESS 70 LEGGINGS, SIZE XXL, MOKA, GRADU...

    Subtalar MBA Implant

    FDA UDI
    Smith & Nephew, Inc.·00885556865941·TRIAL. 9MM

    MBA™ Titanium Subtalar Implant System

    FDA UDI
    Ascension Orthopedics, Inc.·10381780280521·TRIAL MBA SIZE 9MM

    PILLING

    FDA UDI
    TELEFLEX INCORPORATED·24026704505955·

    SILVERVENT

    FDA UDI
    Andreas Fahl Medizintechnik-Vertrieb GmbH·04051948003239·SILVERVENT 1 IC + 1 ICU, SIZE 9

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450139899·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450139059·

    neoWave LS

    FDA UDI
    XENIX MEDICAL LLC·00818345023925·PADDLE SPREADER, 9MM

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0102090·Shaver, Open 9mm

    CAPSTONE SPINAL SYSTEM

    FDA Adverse Event
    Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code MAX·May 1, 2018

    TLS 5.0

    FDA UDI
    CAMBER SPINE TECHNOLOGIES, LLC·B0301000502090·Rotating Scraper, QC, IBFD, 16mm

    ELECTRO-NERVE STIMULATOR TENS, MODEL HE-DIGITAL

    FDA 510(k)
    FDA Class 2 ·Neurology

    DOSE 1

    FDA 510(k)
    FDA Class 2 ·Radiology

    CAPSTONE SPINAL SYSTEM

    FDA Adverse Event
    Injury ·MSD DEGGENDORF MFG·Product code MAX·April 19, 2018

    Multiphor II Electrophoresis System GE HealthCare Product Number: 18-1018-06 PerkinElmer Part Number: 2117-004 Product Usage: Multiphor II Electrophoresis System is a versatile modular electrophoresis system for horizontal electrophoresis, isoelectric focusing, 2-D electrophoresis and electrophoretic transfer Note: The Multiphor II Electrophoresis System (Class I) is the platform used with the hemoglobin electrophoresis gel kit ( Class II) sold by PerkinElmer as the Resolve Hemoglobin Kit (K050709: Product code JJN). The RESOLVE Systems Hemoglobin kit (K050709) is designed to separate whole blood, cord blood or dried blood spot specimen for detection of normal and variant hemoglobins by isoelectric focusing.

    FDA Enforcement
    Class II ·Terminated·Perkinelmer Life Sciences, Inc.·July 12, 2017

    Multiphor II Electrophoresis System GE HealthCare Product Number: 18-1018-06 PerkinElmer Part Number: 2117-004 Product Usage: Multiphor II Electrophoresis System is a versatile modular electrophoresis system for horizontal electrophoresis, isoelectric focusing, 2-D electrophoresis and electrophoretic transfer Note: The Multiphor II Electrophoresis System (Class I) is the platform used with the hemoglobin electrophoresis gel kit ( Class II) sold by PerkinElmer as the Resolve Hemoglobin Kit (K050709: Product code JJN). The RESOLVE Systems Hemoglobin kit (K050709) is designed to separate whole blood, cord blood or dried blood spot specimen for detection of normal and variant hemoglobins by isoelectric focusing.

    FDA Recall
    Terminated ·Perkinelmer Life Sciences, Inc.·Product code JJN·May 15, 2017

    DEPUY METAL INSERT

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS·Product code KWA·March 15, 2013

    FINELINE II

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVN·April 12, 2011

    CARPENTIER-EDWARDS BIOPROSTHESIS

    FDA Adverse Event
    Death ·EDWARDS LIFESCIENCES·Product code LWR·May 23, 2008