BEUDAMED
    9 results · 20ms · Sources: EU EUDAMED, US FDA

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    Safety Pen Needle

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PEEK PREVAIL™ Cervical Interbody Device

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00613994502117·IMPLANT 4210864 STANDALONE 16 X 14 X 8MM

    BIOSPINE VBR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ANALYST PANELS + ANALYTICAL TEST ROTOR

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MAXCEM ELITE

    FDA Adverse Event
    Injury ·KERR CORPORATION·Product code EMA·August 12, 2011

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    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS, INC.·Product code JTC·July 30, 2008

    INGENIO

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·July 8, 2013

    HemoCue¿ Urine Albumin Microcuvettes, 25 Microcuvettes HemoCue AB Angelholm, Sweden The quantitative, rapid, turbidimetric immunoassay of albumin in human urine using a specially designed analyzer, the HemoCue Albumin 201 Analyzer. The system can be used for the quantitative determination of low levels of albumin in urine for the purpose of screening for, diagnosing, monitoring and to supplement the clinical evidence in the treatment of microalbuminuria. The system is designed for testing using spot samples or timed collections. A quantitative result is obtained within 90 seconds. HemoCue Urine Albumin Microcuvettes are for in vitro diagnostic use only. The HemoCue Albumin 201 Analyzer is only to be used with HemoCue Urine Albumin Microcuvettes

    FDA Enforcement
    Class II ·Terminated·HemoCue AB·November 6, 2013

    ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017  S 2000 system 10441730  S 3000 system 10441701  S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015