BEUDAMED
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    INTEGRA EXPANDABLE INTERVEREBRAL BODY FUSION DEVICE (IBD) SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Oticon

    FDA UDI
    Oticon A/S·05707131262141·H11, RITE 312 WL SGR

    DreamWear Full

    FDA UDI
    Respironics, Inc.·00606959046023·DreamWear Full Mask, Medium Wide, with Large Fr...

    DESARA MINI

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

    TSX-101A/A AND TSX-101A/C AQUILION MULTISLICE CT SCANNERS

    FDA 510(k)
    FDA Class 2 ·Radiology

    SUMMIT POR TAPER SZ4 HI OFF

    FDA Adverse Event
    Injury ·1818910 DEPUY ORTHOPAEDICS, INC.·Product code LPH·May 29, 2013

    BI-METRIC STEM

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code LPH·June 14, 2011

    PRECISE BIPOLAR CAUTERY INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL, INC.·Product code NAY·August 22, 2008

    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