BEUDAMED
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    MODIFICATION TO CAVERMAP SURGICAL AID

    FDA 510(k)
    FDA Class 1 ·Gastroenterology, Urology

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756178136·BASIC ORTHO PACK

    Kalitec Special

    FDA UDI
    Kalitec Direct LLC·B073DRK0100080·Dilator Sleeve, Probe

    Savant Lumbar Interbody Fusion System

    FDA UDI
    CURITEVA, INC.·B648C30430100980·PEEK PLIF Spacer, 30 x 10 x 9mm, 8 deg

    InTess C Cervical Cage System

    FDA UDI
    Kalitec Direct LLC·B07309K0100080·Caddie Lid, Implants and Instruments

    Savant Lumbar Interbody Fusion System

    FDA UDI
    CURITEVA, INC.·B648C31430100980·Titanium PLIF Spacer, 30 x 10 x 9mm, 8 deg

    ULTRACISION SURG, DEV, BLADES 5MM OPEN

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC.·Product code LFL·June 16, 2006

    CosmoLock

    FDA UDI
    Kalitec Direct LLC·B073DRK0100280·Tab Breaker, Single Sided, Cosmolock MIS

    Intess C

    FDA UDI
    Kalitec Direct LLC·B07309K0100280·Caddie Lid, Cervical Implants, Hinged

    Kalitec Special

    FDA UDI
    Kalitec Direct LLC·B073DRK0100180·SNII Tap, 6.50mm

    Navagio

    FDA UDI
    Kalitec Direct LLC·B07330K0100280·Caddie, 32-36mm Curved Cages

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07310K0100280·Caddie, MIS Rods and Caps

    PRO.DUCT HEALTH MICRO-STYLET, MODEL STY01

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SOFTLINE SPRING CLIP

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INTERSTIM

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·April 25, 2013

    ENDOPATH THORACIC ENDO LINEAR CUTTER W/SAFETY LOCK

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC.·Product code GAG·November 20, 1997

    OT ULTRA METER

    FDA Adverse Event
    Injury ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 19, 2013

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORP.·Product code LZG·February 11, 2011

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·March 7, 2008

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012