BEUDAMED
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    ELECYS ANTI-CCP CALCHECK

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    MSI Precision Specialty Instruments

    FDA UDI
    Med Saver, Inc.·00194613098841·Sauerbruch Retractor, 45mm x 15mm, Overall Leng...

    ARDO SUCTION PUMP MASTER, MODEL 30.00.XX; ARDO SUCTION PUMP SENATOR, MODEL 31.00.XX

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

    DISPOSABLE PVC POWDERED SYNTHETIC EXAM GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    NCP BIPOLAR LEAD

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·December 30, 2005

    PASSPORT 2 MONITOR

    FDA Adverse Event
    Malfunction ·MINDRAY DS USA, INC.·Product code MHX·April 30, 2013

    NATURALYTE

    FDA Adverse Event
    Injury ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·August 22, 2014

    EON IMPLANTABLE PULSE GENERATOR

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·April 28, 2011

    PROXIMAL HUMERUS, RIGHT, ÿ 9X160MM

    FDA Adverse Event
    Malfunction ·ZIMMER GMBH·Product code HSB·May 14, 2024

    BLUNT TIP SCREW, ÿ 4X40MM

    FDA Adverse Event
    Malfunction ·ZIMMER GMBH·Product code HSB·May 14, 2024

    Drill (Fluted-Hard Bone), for Quattro Link 2.9mm, labeled as: a. Quattro Spade Drill, for 2.9mm, Model Number CM-9300; b. Quattro Drill 2.4mm, Hard Bone, Model Number CM-9324

    FDA Enforcement
    Class II ·Terminated·Cayenne Medical Inc.·August 8, 2018

    Spacelabs Healthcare Arkon Anesthesia Delivery System is intended for use in the hospital environment and operating room. Absorber Adapter Assembly Service Kit, part number: 050-9045-00. Absorber Adapter Assembly, part number: 650-1648-01. Arkon Absorber Canister Carrier, part number: 380-0916-01.

    FDA Enforcement
    Class II ·Terminated·Del Mar Reynolds Medical, Ltd.·May 24, 2017

    Spacelabs Healthcare Arkon Anesthesia Delivery System is intended for use in the hospital environment and operating room. Absorber Adapter Assembly Service Kit, part number: 050-9045-00. Absorber Adapter Assembly, part number: 650-1648-01. Arkon Absorber Canister Carrier, part number: 380-0916-01.

    FDA Recall
    Terminated ·Del Mar Reynolds Medical, Ltd.·Product code BSZ·April 14, 2017

    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