BEUDAMED
    17 results · 21ms · Sources: EU EUDAMED, US FDA

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    GYRUS PLASMAKINETIC SUPERPULSE SYSTEM (GENERATOR, ACCESSORIES)

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

    INTERSURGICAL ECOLITE, ADULT, OXYGEN MASK WITH 31% VENTURI VALVE, ORANGE

    FDA UDI
    Intersurgical Incorporated·05030267128006·INTERSURGICAL ECOLITE, ADULT, OXYGEN MASK WITH ...

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0310050·Probe, 1.5 inch Ball, Lenke, Curved, Black

    Citrelock ACL 8.5mm Tibial Reamer

    FDA UDI
    Acuitive Technologies, Inc.·00810027271167·

    Kalitec Universal Instruments

    FDA UDI
    Kalitec Direct LLC·B07301K0380850·T-Handle, Stealth, Quarter Square, Impact

    GUIDEWIRE INTRODUCER SAFETY NEEDLE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MODIFICATION TO ONYX, FINGER CLIP PULSE OXIMETER, MODEL 9500

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·February 5, 2025

    SIGMA STAB GVF INS 3 12.5MM

    FDA Adverse Event
    Injury ·DEPUY (IRELAND) 9616671·Product code JWH·April 2, 2013

    V.A.C. THERAPY SYSTEM

    FDA Adverse Event
    Injury ·KCI USA, INC.·Product code OMP·March 22, 2011

    ICY HOT HEAT THERAPY PATCH

    FDA Adverse Event
    Other ·CHATTEM, INC.·Product code IMD·April 15, 2008

    Synthes Soft Tissue Retractor Small Extendible Offset blade facilitates easy preparation of the epipereosteal cavity for percutaneous plate insertion.

    FDA Enforcement
    Class II ·Terminated·Synthes USA HQ, Inc.·November 27, 2013

    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

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013