BEUDAMED
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    CROSSFUSE II CORONAL TAPER, CROSSFUSE II HYPERLORDOTIC

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PIVOX™ Oblique Lateral Spinal System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00643169606159·SPACER 2133455 OLIF25 27MM 18 DEG 14X55

    HHM

    FDA UDI
    Oticon A/S·05707131261656·H100, BTE 13 WL 85 STG HHM

    Zavation

    FDA UDI
    Zavation LLC·00197157006181·Custom Tap/5.5mm

    SPECTRA LASER SYSTEM

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

    ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS03-5

    FDA 510(k)
    FDA Class 2 ·Neurology

    AMISTEM H, HA COATED STEM SIZE 4 STD

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·September 30, 2016

    OCTRODE

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

    UNKNOWN

    FDA Adverse Event
    Injury ·SMTIH & NEPHEW, INC. ORTHOPAEDIC DIVISION·Product code JWH·June 20, 2011

    SALINE FILLED BREAST IMPLANT

    FDA Adverse Event
    Injury ·MCGHAN·Product code FWM·August 22, 2008

    Integra CUSA Excel Disposable Wrench. Catalog Number C5601. The CUSA Excel+ Sterile 23 kHz Torque Wrench is an accessory used with the CUSA Excel+ System ultrasonic surgical instrument. The torque wrench is used to properly secure the CUSA tip to the CUSA handpiece in the sterile field.

    FDA Enforcement
    Class II ·Terminated·Integra LifeSciences Corp.·May 7, 2014

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Enforcement
    Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

    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