BEUDAMED
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    EVEREST BIPOLAR LYONS DISSECTING FORCEPS & GYRUS BIPOLAR LYONS DISSECTING FORCEPS

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    N/A

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00643169342354·INTRDSCL DRIL GUIDE 3031080

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0310080·Probe, 1.5 inch Ball, Lenke, Thoracic, Straight...

    Citrelock ACL 8mm Tibial Reamer

    FDA UDI
    Acuitive Technologies, Inc.·00810027271150·

    SPINE SYSTEM EVOLUTION

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BRIDGE SE SELF-EXPANDING STENT DELIVERY SYSTEM

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

    ULTRA DRIVE 6MM PLUG PULLER

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDX·July 20, 2022

    WAVELIGHT FS200 FEMTOSECOND LASER

    FDA Adverse Event
    Malfunction ·WAVELIGHT GMBH·Product code GEX·March 28, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·March 16, 2011

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL MANUFACTURING CORPORATION·Product code MVK·July 17, 2014

    M2A MAGNUM MODULAR HEAD 50MM HEAD DIAMETER

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·December 29, 2016

    Smith & Nephew FOOTPRINT Ultra PK Suture Anchor, 5.5mm Part Number: 72202902

    FDA Enforcement
    Class II ·Ongoing·Smith & Nephew, Inc.·April 29, 2020

    Spirit Plus Bed, A-C Powered Hospital Bed

    FDA Enforcement
    Class II ·Terminated·CHG Hospital Beds Inc·August 10, 2016

    Spirit Select Bed, A-C Powered Hospital Bed

    FDA Enforcement
    Class II ·Terminated·CHG Hospital Beds Inc·August 10, 2016

    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

    The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018