BEUDAMED
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    IR PRO 250

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    AOS CAPTURED CANCELLOUS SCREW, PARTIAL THREAD 6.0mm x 80mm

    FDA UDI
    ADVANCED ORTHOPAEDIC SOLUTIONS, INC.·00848665021042·

    Waterpik Getz Contour Matrix Bands "Dixieland Band"

    FDA UDI
    WATER PIK, INC.·D6860610800003·Ultra-Thin

    N/A

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036025960·

    Kalitec Disc Prep

    FDA UDI
    Kalitec Direct LLC·B07319K0160800·Curette, Stirrup, 4mm

    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

    LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET

    FDA Adverse Event
    Injury ·COOK VASCULAR INC·Product code DRE·September 8, 2015

    LEAD EXTRACTION EVOLUTION SHORTIE RL CONTROLLED-ROTATION DILATOR SHEATH SET

    FDA Adverse Event
    Injury ·COOK VASCULAR INC·Product code DRE·September 9, 2015

    TRILOGY 100

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code CBK·April 9, 2013

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    FDA Adverse Event
    Other ·MERITS HEALTH PRODUCTS CO., LTD.·Product code FNL·April 7, 2011

    FREESTYLE

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC.·Product code LFR·June 13, 2008

    BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584648 Ophthalmic surgical kits

    FDA Enforcement
    Class II ·Terminated·Beaver-Visitec International Inc.·June 24, 2015

    REGENEREX 3 PEG SERIES A PATELLA 37MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code MBH·March 29, 2019

    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

    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015