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    SALVATION External Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    INTREPED, Intraosseous Fusion Device

    FDA UDI
    Auxano Medical LLC·00850055649620·INTREPED K-Wire Depth Gauge

    VASER

    FDA UDI
    SOLTA MEDICAL·00816995026235·SKIN PORT,COMBO,START.KIT, 8PK

    TMA - Archwire

    FDA UDI
    ORMCO CORPORATION·00889989029413·ARCH TMA REV.CURVE UPR 17X025 PK/10

    LOCATOR R-Tx

    FDA UDI
    Zest Anchors, LLC·00840481119156·LOCATOR R-Tx Abutment For 3.0mm Platform Legacy...

    General Instruments

    FDA UDI
    ALPHATEC SPINE, INC.·00840180525425·Pituitary, Straight Biting, Straight, 4mm

    ASC TRIPORT+ LAPAROSCOPIC ACCESS DEVICE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    PHILIPS HEARTSTART FRX DEFIBRILLATOR, MODEL 861304

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    N/A

    FDA UDI
    Zimmer, Inc.·00889024033573·

    MENICON ASRB (ASMOFILCON A) SILICONE HYDROGEL SOFT CONTACT LENS

    FDA Adverse Event
    Injury ·MENICON CO., LTD.·Product code LPL·March 18, 2026

    Dorsal Root Ganglion Stimulator For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·Axium Neurostimulator System

    MENICON ASRB (ASMOFILCONA)

    FDA Adverse Event
    Injury ·MENICON CO., LTD.·Product code LPL·February 25, 2025

    MENICON ASRB (ASMOFILCONA)

    FDA Adverse Event
    Injury ·MENICON CO., LTD.·Product code LPL·January 14, 2025

    SERVO-I

    FDA Adverse Event
    Malfunction ·MAQUET CRITICAL CARE AB·Product code CBK·June 3, 2013

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·July 5, 2011

    FLEXOR RAABE GUIDING SHEATH

    FDA Adverse Event
    Injury ·COOK, INC.·Product code DYB·August 27, 2008

    SHIRANUI EX

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code LIT·September 11, 2022

    SHIRANUI EX

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code LIT·April 14, 2026

    Philips HeartStart FRx 861304 Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA; and Laerdal branded FRx 861305 The FRx Defibrillator is intended to treat ventricular fibrillation, the most common cause of sudden cardiac arrest. Using voice prompts, light emitting diodes (LEDs) and buttons, the user is guided through the response. The FRx uses a SMART biphasic, impedance compensating exponential waveform to deliver a nominal 150 J to adults and nominal 50 J to infants/children.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems North America Co. Phillips·January 16, 2013

    SHIRANUI EX

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code LIT·May 24, 2021