BEUDAMED
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    18M - Loggers - 18 Metal

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588015057·18M - Loggers - 18 Metal

    Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Cardiovascular Procedure Kit

    FDA UDI
    Terumo Cardiovascular Systems Corporation·00699753479272·

    K2 OPAQUER powder, O-A4, 15g.

    FDA UDI
    Yeti Dentalprodukte GmbH·EYET3201505·

    Lockheed - 18 Metal

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588015026·Lockheed - 18 Metal

    16PW - Loggers - Poly White

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588015040·16PW - Loggers - Poly White

    Arena-C®

    FDA UDI
    SPINEFRONTIER, INC.·00190361036579·Trial Spacer, Assembly, Straight, 5mm

    APPLE ECG (ELECTROCARDIOGRAPH) APP

    FDA Adverse Event
    Injury ·APPLE INC.·Product code QDA·July 5, 2023

    RTVUE MODEL RTVUE 100

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    ONLINE DAT II METHADONE II

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    POUNCE VENOUS THROMBECTOMY SYSTEM

    FDA Adverse Event
    Injury ·SURMODICS INC·Product code QEW·May 16, 2024

    MICRODRILL SERIES STRAIGHT ATTACHMENT

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code EIA·July 24, 2018

    HUDSON CIRCUIT, NEONATAL, DUAL HTD LIMB W/18 IN

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code BZO·August 3, 2011

    COLLAMER ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    FDA Adverse Event
    Injury ·STAAR SURGICAL CO.·Product code HQL·October 17, 2008

    ANEURX

    FDA Adverse Event
    Injury ·MEDTRONIC CARDIOVASCULAR SANTA ROSA·Product code MIH·July 2, 2013

    MICROTEK MEDICAL, INC, STACKHOUSE LASER RESISTANT SUCTION PROBE, Size: 1/4" x 9" (0.64cm x 22.9cm), REF 24014, QTY 10 EA, STERILE EO, 2015-05, Microtek Medical, Inc. , Columbus, MS 39702, www.microtekmed.com, CE0044, EC REP Microtek Medical B.V. , Zutphen, The Netherlands, Manufactured in the U.S.A. Suction probe for a smoke evacuation device

    FDA Recall
    Terminated ·Microtek Medical Inc·Product code FYD·May 25, 2010

    Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped with iVue System (K091404) and the "Retina Poster" shipped with iVue System (K091404) and RTVue Systems (K101505); Models: iVue-100, RTVue-100; The physical Product is manufactured and distributed by Optovue, Inc. Fremont, CA The product is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retina, retinal nerve fiber layer, optic disk, and for cornea and anterior eye scans as an aid in the diagnosis and management of retinal disease.

    FDA Enforcement
    Class II ·Terminated·Optovue Inc.·October 31, 2012

    Terumo Custom Cardiovascular Procedure Kit- CUSTOM X-COATED LOW PRIME 3/8 x1/2 pack Product Code:72015-05 Manufactured to the design and specifications of the purchaser/user) for the application it is intended.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corp·Product code DTZ·April 12, 2012

    TRUE 3D VIEWER SYSTEM Model Number EP-00001-XX Software versions 1.0, 1.25, and 1.35 The t3D-Viewer is designed for use by health care professionals HCPs and is intended to assist the clinician who is responsible for making all patient management decisions. The True 3D Viewer (t3D-Viewer) system is comprised of a commercial off the shelf hardware platform and a proprietary software application that enables a health care professional (HCP) to visualize and interact with CT and MRI DICOM image data to assist in clinical decision making. The t3D-Viewer system hardware platform is comprised of an off the shelf stereoscopic display, an optical or electromagnetic motion tracking system and a computer system.

    FDA Enforcement
    Class II ·Ongoing·Echopixel, Inc.·May 28, 2025

    Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped with iVue System (K091404) and the "Retina Poster" shipped with iVue System (K091404) and RTVue Systems (K101505); Models: iVue-100, RTVue-100; The physical Product is manufactured and distributed by Optovue, Inc. Fremont, CA The product is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retina, retinal nerve fiber layer, optic disk, and for cornea and anterior eye scans as an aid in the diagnosis and management of retinal disease.

    FDA Recall
    Terminated ·Optovue Inc.·Product code OBO·September 7, 2012