BEUDAMED
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    MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP-3BU1

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Leksell Gamma Knife Perfexion

    FDA UDI
    Elekta Instrument AB·07340048306171·QA TOOL

    artVeneer life

    FDA UDI
    Merz Dental GmbH·D7092001182·artVeneer life upper anteriors, ITL, B1

    36M - Black & Veach - Metal

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588011820·36M - Black & Veach - Metal

    SHIELDED SYRINGE CARRIERS

    FDA UDI
    BIODEX MEDICAL SYSTEMS, INC.·00718175000793·Syringe Carrier, Small, .25" Lead

    Syringe Carrier, Small 0.25" lead

    FDA UDI
    Mirion Technologies (capintec), Inc.·00859942006799·Syringe Carrier, Small 0.25" lead

    Diagon

    FDA UDI
    CAMBER SPINE TECHNOLOGIES, LLC·B030MO0011820·15°, 12mm x 39mm x 14mm Oblique ASM

    STACKHOUSE SMOKE EVACUATOR, MODELS ST-3000, ST 3100

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

    HARDYDISK TOBRAMYCIN, 10MCG

    FDA 510(k)
    FDA Class 2 ·Microbiology

    CARDIOSAVE HYBRID, 3.1 EDITION

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.·Product code DSP·October 15, 2025

    IOLMASTER 500

    FDA Adverse Event
    Malfunction ·CARL ZEISS MEDITEC AG (JENA)·Product code HJO·October 14, 2015

    IMPAX CV REPORTING

    FDA Adverse Event
    Malfunction ·AGFA HEALTHCARE CORP·Product code LLZ·February 26, 2013

    FLEXIMA CATHETER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - SPENCER·Product code FFA·February 24, 2011

    2600

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·February 22, 2008

    IV ADMINISTRATION SET

    FDA Adverse Event
    Malfunction ·B. BRAUN MEDICAL INC.·Product code FPA·June 25, 2024

    Synthes Sciatic Nerve Retractor and Sciatic Nerve Retractor Long; Synthes Sciatic Nerve Retractor and Sciatic Nerve Retractor Long are system specific instruments to the 3.5 mm Low Profile Pelvic System Retractor Set.

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·August 26, 2015

    ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Model 96281 is intended for use with either adult or neonatal patient populations in a hospital environment.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare, Llc·February 5, 2014

    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

    BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators are anesthesia gas machine. In most cases, the customer ordered both a BleaseFocus anesthesia workstation and a 700/900 ventilator. In some cases, the customer may order a 700/900 stand-alone ventilator would could be used with a BleaseFocus anesthesia workstation at a later date.

    FDA Enforcement
    Class II ·Terminated·Del Mar Reynolds Medical, Ltd.·December 26, 2012

    Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly

    FDA Enforcement
    Class II ·Ongoing·Covidien·August 28, 2024