BEUDAMED
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    TRACK 1.0 & 1.5 MM SYSTEMS-TISSUE REGENERATION BY ALVEOLAR CALLUS DISTRACTION

    FDA 510(k)
    FDA Class 2 ·Dental

    artVeneer life

    FDA UDI
    Merz Dental GmbH·D7092002152·artVeneer life upper posteriors, L, D4

    SCANLAN®

    FDA UDI
    SCANLAN INTERNATIONAL INC·00846159018233·Vascular Clamp 18 mm Jaw

    JBC

    FDA UDI
    FOREMOUNT ENTERPRISE CO., LTD.·04719871892329·Anesthesia Mask, Size 6, Adult

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112878·CORNEAL TREPHINE BLADE6.5MM

    SURGITEK OPTIMAM MAMMARY PROSTHESIS

    FDA Adverse Event
    MEDICAL ENGINEERING CORP.·Product code FTR·May 23, 1994

    HEYER-SCHULTE MAMMARY PROSTHESIS

    FDA Adverse Event
    V. MUELLER DIV. BAXTER HEALTHCARE CORP.·Product code FTR·May 23, 1994

    SURGITEK MAMMARY PROSTHESIS

    FDA Adverse Event
    MEDICAL ENGINEERING CORP.·Product code FTR·May 23, 1994

    MINIMED MIO ADVANCE

    FDA Adverse Event
    Injury ·UNOMEDICAL A/S·Product code FPA·April 28, 2025

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523151035·Kerrison Rongeur, 6mm - Angled Left

    KIPPMED I.V. MANIFOLD

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MAXHEALTH WHEELCHAIR, MODEL HE-8631, HE-8621, HE-8651

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    HEARTSINE SAMARITAN 300P AND PAD PAK

    FDA Adverse Event
    Malfunction ·HEARTSINE TECHNOLOGIES, LTD·Product code MKJ·February 11, 2013

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·February 4, 2011

    MEDLEY, PC

    FDA Adverse Event
    Malfunction ·ALARIS MEDICAL SYSTEMS, INC.·Product code FRN·January 24, 2008

    Reprocessed Stryker Color Cuff and Color Cuff II Adult Tourniquet Cuffs Model Numbers: 5921-218-135, 5921-044-135, 5921-034-135, 5921-034-235, 5921-024-236 Indicated for use in patients who require surgery of the extremities.

    FDA Enforcement
    Class II ·Terminated·Stryker Sustainability Solutions·January 20, 2016

    Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates.

    FDA Enforcement
    Class I ·Terminated·Smiths Medical ASD, Inc.·August 8, 2012

    Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic

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

    Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013

    Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names: MEDFUSION¿ 4000 Pump V1.0; MEDFUSION¿ 4000 Pump V1.1, v1.1.1, v1.1.2; MEDFUSION¿ 4000 Pump V1.1, V1.1.1, V1.1.2; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.6, V1.6.1 Product Usage: The pumps are indicated for the following uses: 1. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2. By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3. By the following delivery modes: continuous, volume/time, mass, body weight, intermittent and bolus.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·October 2, 2019