BEUDAMED
    19 results · 25ms · Sources: EU EUDAMED, US FDA

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    ULTRASONIC SCALER, MODELS VARIOS 350 LUX, VARIOS 350 (NO LIGHT), VARIOS 550, VARIOS 150 LUX, VARIOS 150 (NO LIGHT)

    FDA 510(k)
    FDA Class 2 ·Dental

    AMDS Hybrid Prosthesis ("AMDS")

    FDA UDI
    Artivion, Inc.·00877234001208·40mm – 30mm Tapered Stent (24mm collar)

    LIFEGUARD NASAL CPAP MASK AND ACCESSORIES

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ONTRAK TESTCUP 501, MODEL 3016633

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 2, 2013

    GOBED II

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·February 24, 2011

    FOOTED ATTACHMENT 2.4MM LEGEND, AF02 (B-1)

    FDA Adverse Event
    Malfunction ·MEDTRONIC POWERED SURGICAL SOLUTIONS·Product code HBB·April 18, 2008

    CONTINUUM ACETABULAR SHELL WITH CLUSTER HOLES

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·June 7, 2018

    LARGE EX-FIX OPEN ADJ CLAMP MR-CONDITIONAL

    FDA Adverse Event
    Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018

    NEUTRAL LINER

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDI·June 7, 2018

    SELF TAPPING BONE SCREW

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·June 7, 2018

    ZIMMER M/L TAPER MODULAR FEMORAL STEM WITH KINECTIV TECHNOLOGY PRESS-FIT

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code LPH·June 15, 2016

    LARGE EX-FIX OPEN ADJ CLAMP MR-CONDITIONAL

    FDA Adverse Event
    Malfunction ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code KTT·February 13, 2018

    LARGE EX-FIX OPEN ADJ CLAMP MR-CONDITIONAL

    FDA Adverse Event
    Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code KTT·April 12, 2018

    The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.

    FDA Enforcement
    Class II ·Terminated·CHG Hospital Beds Inc·March 23, 2016

    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

    Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quadra Assura MP, Model No. CD3269-40, CD3269-40Q, CD3369-40C. Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing. Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing

    FDA Enforcement
    Class I ·Terminated·St Jude Medical Inc.·November 2, 2016