BEUDAMED
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    MEDMIRA RAPID H. PYLORI ANTIBODY TEST, MODEL 10714

    FDA 510(k)
    FDA Class 1 ·Microbiology

    Duesseldorf Type Bell Partial

    FDA UDI
    Heinz Kurz GmbH·EHKM10020231·Ossicular prosthesis, partial

    artVeneer life

    FDA UDI
    Merz Dental GmbH·D7092002023·artVeneer life lower posteriors, L, A3

    nGenius

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·07613327353600·SPINE CLAMP

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0120230·Screwdriver, Extended Tab, Fixed Tap Sleeve, As...

    DULBECCO'S MODIFIED EAGLE'S MEDIUM, NO. 200-2023

    FDA 510(k)
    FDA Class 1 ·Hematology

    BREAST IMPLANT

    FDA Adverse Event
    DOW CORNING CORP.·Product code FTR·May 17, 1994

    NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    FRIENDLY LIGHT ER:YAG PULSED LASER

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

    DEXTRUS 4136

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO. KG·Product code NVN·March 13, 2013

    PUMP/GRAVITY SOLUTION NO 'Y' SITE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MALTA·Product code FPA·February 27, 2011

    ICY HOT HEAT THERAPY-BACK PATCH

    FDA Adverse Event
    Injury ·*·Product code IMD·February 20, 2008

    ONYX

    FDA Adverse Event
    Injury ·MICRO THERAPEUTICS, INC. DBA EV3·Product code MFE·October 16, 2024

    Verigene Enteric Pathogens Nucleic Acid Test (EP), REF 30-002-023

    FDA Recall
    Open, Classified ·Luminex Corporation·Product code PCH·June 5, 2023

    CLEARSIGN II Amplifier for LABSYSTEM PRO EP Recording System, 120 channels, using firmware version 2.08. The channel numbers in the amplifier are as follows: Material number: H30120020210 - 40 Channel CLEARSIGN II Amplifier, catalog number 2002021; Material number: H30120020220 80 Channel CLEARSIGN II Amplifier, catalog number 2002022; Material number: H30120020230 120 Channel CLEARSIGN II Amplifier, catalog number 2002023; Material number: H30120020240 160 Channel Clearsign II Amplifier, catalog number 2002014. The CLEARSIGN II Amplifier is intended to amplify and condition electrocardiographic signals of biologic origin and pressure transducer input, transmitting this information to a host computer (the LABSYSTEM PRO EP Recording System) that can record and display the information

    FDA Enforcement
    Class II ·Terminated·Boston Scientific Corporation·June 24, 2015

    HAMILTON MEDICAL AG

    FDA Adverse Event
    Malfunction ·HAMILTON MEDICAL AG·Product code CBK·December 21, 2023

    Verigene Enteric Pathogens Nucleic Acid Test (EP), REF 30-002-023

    FDA Enforcement
    Class II ·Ongoing·Luminex Corporation·July 5, 2023

    CLEARSIGN II Amplifier for LABSYSTEM PRO EP Recording System, 120 channels, using firmware version 2.08. The channel numbers in the amplifier are as follows: Material number: H30120020210 - 40 Channel CLEARSIGN II Amplifier, catalog number 2002021; Material number: H30120020220 80 Channel CLEARSIGN II Amplifier, catalog number 2002022; Material number: H30120020230 120 Channel CLEARSIGN II Amplifier, catalog number 2002023; Material number: H30120020240 160 Channel Clearsign II Amplifier, catalog number 2002014. The CLEARSIGN II Amplifier is intended to amplify and condition electrocardiographic signals of biologic origin and pressure transducer input, transmitting this information to a host computer (the LABSYSTEM PRO EP Recording System) that can record and display the information

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code DRQ·June 2, 2015

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024