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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    HEM-7320

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Oticon

    FDA UDI
    Oticon A/S·05707131261076·H10, MINIRITE 312 WL SGR

    DreamWear Full

    FDA UDI
    Respironics, Inc.·00606959046061·DreamWear Full Mask, Medium Wide, with Medium F...

    TRIAGE BNP TEST FOR THE BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL CATALOG #98200

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SPARTEK VARIABLE ANGLE PEDICLE SCREW POSTERIOR FUSION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·May 20, 2013

    UNKNOWN DEPUY SZ 2.5, 10MM CR TIBIAL INSERT

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JWH·June 13, 2011

    CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code LWR·August 22, 2008

    OPTIVANTAGE DH

    FDA Adverse Event
    Injury ·LIEBEL-FLARSHEIM CO.·Product code IZQ·February 17, 2010

    Philips Respironics DreamWear Full Face Mask

    FDA Enforcement
    Class I ·Ongoing·Philips Respironics, Inc.·October 12, 2022

    Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015