BEUDAMED
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    MODULAR PORP AND TORP MODEL TBD

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    D6-2A Ultrasonic Probe (FDA) (JP)

    FDA UDI
    Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06944904088204·

    BIOCUFF, MODELS 225718, 225728, 225736, 235718, 235728, 235736

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BACT/ALERT MB CULTURE BOTTLE

    FDA 510(k)
    FDA Class 1 ·Microbiology

    COAPTITE

    FDA Adverse Event
    Other ·BIOFORM MEDICAL, INC.·Product code LMH·October 13, 2006

    G7 ACETABULAR SYSTEM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code PBI·May 15, 2026

    ARCOS MODULAR REVISION HIP SYSTEM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·May 15, 2026

    ARCOS MODULAR REVISION HIP SYSTEM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·May 15, 2026

    BIGLIANI/FLATOW OFFSET HUMERAL HEAD

    FDA Adverse Event
    Malfunction ·ZIMMER, INC.·Product code HSD·March 7, 2013

    GORE PROPATEN VASCULAR GRAFT

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES, INC.·Product code DSY·February 16, 2011

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·August 12, 2014

    UNKNOWN KNEE TIBIAL TRAY

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code JWH·September 6, 2019

    VS3 Iridium Visionsense Infrared (IR) Fluorescence Miniature Microscope (MMS-IR) Product Number: 174-0012

    FDA Enforcement
    Class II ·Ongoing·Visionsense, Ltd.·November 30, 2022

    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

    Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    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

    Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians and health care workers and may be only used under the supervision of a physician. This device will not be sold to the general public. The IOLMaster is intended for the biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec, Inc.·November 27, 2013