BEUDAMED
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    LINEAGE A-CLASS POLY LINER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    JOBST forMen

    FDA UDI
    BSN MEDICAL, INC.·04042809847802·FOR MEN 15-20 MM HG KNEE HIGH OPEN TOE SMALL-LO...

    Intelliguides

    FDA UDI
    Mios Marketing, LLC·G2710400520260·Anterior Dome Osteotomy Guide, 52mm x 24mm

    AXIUM 3-D AND HELICAL DETACHABLE COIL

    FDA Adverse Event
    Malfunction ·EV3 NEUROVASCULAR·Product code HCG·March 15, 2012

    TRIDENT ALL POLY CUP

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CAPIOX ARTERIAL FILTER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Injury ·DEXCOM, INC.·Product code QBJ·January 17, 2026

    C-Rex UNO Microinterventional Goniotomy Instrument. Model Number: CRX-120. Product Description: The C-Rex UNO Microinterventional Goniotomy Instrument is a sterile single use disposable manual surgical instrument used in ophthalmic procedures for ab interno goniotomy and inner wall trabeculotomy.

    FDA Enforcement
    Class II ·Ongoing·Iantrek Inc.·October 22, 2025

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·April 11, 2013

    DEK BL MF 0 TAPER-CUT SUTURE

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code GAW·February 28, 2011

    ACUMEND K-WIRE

    FDA Adverse Event
    ACUMED, LLC·Product code HTY·May 15, 2008

    GXL NUETRAL LINER, G0 28MM ID

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JDI·April 20, 2023

    Cyclopen Microinterventional Cyclodialysis System. Model Number: CP-300. Product Description: The CycloPen Microinterventional Cyclodialysis device is a manual surgical instrument used for the ab-interno construction or modification of a cyclodialysis, followed by delivery of viscous materials, bio-tissue/allograft, or other materials to reinforce and maintain the cleft.

    FDA Enforcement
    Class II ·Ongoing·Iantrek Inc.·October 22, 2025

    Thuvera Laser Console. Software Version 2.2. Portable Thulium Fiber Laser.

    FDA Recall
    Open, Classified ·IPG Medical Corporation·Product code GEX·May 5, 2026

    Philips Telemetry Monitor 5500 1.4 GHz. Model Number: 867232. Includes the following system descriptions: TELE Monitor 5500, 1.4 Ghz, ECG only, ex; Telemetry Monitor 5500 1.4 GHz FAST EX.

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code MHX·June 5, 2026

    Brand Name: Spacelabs Ultraview SL Command Module Product Name: SL Command Module Model/Catalog Number: 91496 Software Version: N/A Product Description: The Command Module (91496) is the core of the Spacelabs patient monitoring system, providing the processing power for all basic physiologic parameters. The Command Module inserts into the side of a Spacelabs patient monitor. A variety of configurations can be selected to suit the monitoring needs of specific patients or care units in the hospital. Component: N/A

    FDA Recall
    Open, Classified ·Spacelabs Healthcare, Inc.·Product code DSI·March 26, 2026