BEUDAMED
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    ML24000 UVA-1 PHOTOTHERAPY UNIT

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

    Liqui-Jet 2

    FDA UDI
    STERIS CORPORATION·00724995011864·Liqui-Jet 2, 1 Gallon is a concentrated, alkali...

    ScrewPlant® Implant

    FDA UDI
    IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307104902·3.7mmD x 8mmL, 3.7mmD Platform

    RHOTON INSTRUMENT TRAY

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896053328·RHOTON INSTRUMENT TRAY STAINLESS STEEL MESH

    Tasso Mini

    FDA UDI
    Tasso Inc.·00850038691141·

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776206178·Sterilization and Storage Thermoplastic Container

    38MM M2A INSTRUMENTS

    FDA UDI
    Biomet Orthopedics, LLC·00880304299825·

    ScrewPlant®/ ScrewPlus® Open-Tray Transfer

    FDA UDI
    IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307121176·

    ADVANTAGE THC/COCAINE TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    REFERENCE CHECK, CATALOG NUMBER-RCN-10

    FDA 510(k)
    FDA Class 2 ·Hematology

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 9, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 19, 2014

    QUATTRODE LEAD WIDE SPACED, 30 CM

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 24, 2011

    GALAXY G3 XSFT 4MM X 8CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·April 14, 2022

    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

    VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    Spacelabs Healthcare qube Compact Monitor, Model 91390. The Spacelabs Healthcare qube Compact Monitor (91390), functioning as either bedside or central monitors; passively displays data generated by Spacelabs Healthcare parameter modules, Flexports interfaces, and other SDLC based products in the form of waveform and numeric displays, trends and alarms. Key monitored parameters available on the Model 91390 when employing the Spacelabs Command Module, consist of ECG, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·March 4, 2015