BEUDAMED
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    Cerebral Adaptive Index (CAI) Algorithm

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LCP

    FDA UDI
    Synthes GmbH·10886982158086·3.5MM LCP PLATE 15 HOLES 202MM

    TechNH, INC.

    FDA registration
    TechNH, INC.·4 products·🇺🇸 United States

    VECTORVISION CRANIAL/ENT

    FDA 510(k)
    FDA Class 2 ·Neurology

    CINCHLOCK KNOTLESS SUTURE ANCHOR

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 25, 2011

    MICRO INCISION VACUUM PAK

    FDA Adverse Event
    Malfunction ·BAUSCH & LOMB, INC.·Product code HQC·August 5, 2014

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·July 10, 2013

    MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 2024

    BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest.

    FDA Enforcement
    Class II ·Ongoing·Biointellisense Inc.·August 21, 2024

    Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor

    FDA Enforcement
    Class II ·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026