BEUDAMED
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    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Oticon

    FDA UDI
    Oticon A/S·05707131271334·ALTA PRO, KIT 10 WL OMNI 85 BE

    N/A

    FDA UDI
    TETRA MEDICAL SUPPLY CORP.·00614138122444·TETRA ULTRA ORTHO SHOE MALE SMALL

    PRIMARY TREPHINE

    FDA UDI
    Biomet Orthopedics, LLC·00887868004087·

    3M™ Unitek™

    FDA UDI
    3M UNITEK CORPORATION·00652221037268·Unitek(TM) Bicuspid Band General Purpose Wide L...

    K2M General Instruments

    FDA UDI
    VB Spine LLC·10888857580961·Split Tube Retractor Ø12x30 mm

    NEUMOVENT GRAPHNET MODEL 3179L1V

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MODIFICATION TO M2376A DEVICELINK SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    UNKNOWN

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·August 5, 2022

    OT VERIO PRO METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 3, 2013

    IN TOUCH ZU

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·June 1, 2011

    SOFTCLIX LANCET DEVICE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·September 3, 2008

    LF HIGH FLOW CVC CATHETER

    FDA Adverse Event
    Other ·ICU MEDICAL, INC.·Product code FOZ·June 10, 2010

    CLAREON IOL WITH THE AUTONOME DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·ALCON LABORATORIES IRELAND LTD.·Product code HQL·December 15, 2025

    CLAREON IOL WITH THE AUTONOME DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·ALCON LABORATORIES IRELAND LTD.·Product code HQL·November 17, 2025

    ACRYSOF IQ ASPHERIC UV ABSORBING IOLWITH ULTRASERT DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·ALCON RESEARCH, LLC - HUNTINGTON·Product code HQL·April 16, 2025

    NAVIS-EX , Image Filing Software for NIDEK AFC Fundus camera, Ver 1.1.0 to 1.3.5. NAVIS-EX is indicated for use as file management software for ophthalmic images.

    FDA Enforcement
    Class II ·Terminated·Nidek Inc·September 4, 2013

    PKG, ROTATING HANDLE, W/RATCHET, INSULATED SHAFT, P/N 0250080234. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014

    Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.

    FDA Enforcement
    Class II ·Terminated·Ecolab Inc·September 30, 2015

    Veradius Unity with Software Release 2.1- Amobile, diagnostic X-ray imaging and viewing system. . Model Number: 718132

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 15, 2021