BEUDAMED
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    ISCIENCE INTERVENTIONAL OPHTHALMIC MICROCATHETER

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

    STAR

    FDA UDI
    Stryker GmbH·00886385017303·Tibial Cut Block Assembly, LEFT

    Plate Trial

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215043797·

    Disposable Cuff

    FDA UDI
    SUNTECH MEDICAL, INC.·10840935105275·

    GYRUS ENT SOMNOPLASTY GENERATOR

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

    ALKALINE PHOSPHATASE LIQUID REAGENT-KINETIC, MODELS A504-150 AND A504-500H

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CELOX GAUZE

    FDA Adverse Event
    Injury ·MEDTRADE PRODUCTS LIMITED·Product code FRO·February 14, 2023

    CELOX GAUZE

    FDA Adverse Event
    Injury ·MEDTRADE PRODUCTS LIMITED·Product code FRO·October 12, 2022

    BD INTIMA-II Y 24GAX0.75IN PRN/EC SLM

    FDA Adverse Event
    Malfunction ·BD (SUZHOU)·Product code FOZ·January 4, 2024

    ZILVER FLEX 35 BILIARY SELF-EXPANDING STENT

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FGE·February 24, 2017

    RIATA PASSIVE FIXATION

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·April 26, 2013

    POLYFLUX LR CAPILLARY DIALYZER

    FDA Adverse Event
    Malfunction ·GAMBRO DIALYSATOREN GMBH·Product code MSF·July 24, 2008

    HEMODIALYSIS KIT: 2-L 15 FR X 24 CM

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL INC·Product code MSD·April 7, 2011

    ZILVER FLEX 35 BILIARY SELF-EXPANDING STENT

    FDA Adverse Event
    Malfunction ·COOK INC·Product code NIO·July 25, 2017

    CELOX GAUZE

    FDA Adverse Event
    Injury ·MEDTRADE PRODUCTS LIMITED·Product code QSY·June 10, 2025

    -INTIMA-II Y 24GAX0.75IN PRN/EC SLM

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FOZ·December 7, 2023

    BD INTIMA-II Y 22GAX1.00IN PRN

    FDA Adverse Event
    Malfunction ·BD (SUZHOU)·Product code FOZ·November 29, 2023

    Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black; MT20649-PNK, Receiver (mg/dL), Pink; MT20649-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.

    FDA Enforcement
    Class I ·Terminated·Dexcom Inc·April 20, 2016