BEUDAMED
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    CRYO-TOUCH IV

    FDA 510(k)
    FDA Class 2 ·Neurology

    N/A

    FDA UDI
    TETRA MEDICAL SUPPLY CORP.·00614138127470·BICRO KNEE IMMOBILIZER W/PATELLA STRAP 16IN UN

    SMARTLOCK

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·04546540492043·LOCKING SCREW, CROSS-PIN

    Sochi

    FDA UDI
    Altus Spine, LLC·00843210166469·Polyaxial Screw, 3.5mm x 16mm

    Segmental Plating System

    FDA UDI
    ALPHATEC SPINE, INC.·00190376536170·SPS VA Self-Drill Screw, 3.5 x 16 mm

    Atoll™

    FDA UDI
    Seaspine Orthopedics Corporation·10889981052355·3.5mm x 16mm Poly Screw Assm. The Atoll OCT Spi...

    Proximity

    FDA UDI
    ALPHATEC SPINE, INC.·00190376657127·PROXIMITY VA SELF-DRILL SCREW, 3.5 x 16mm

    Complete Cervical

    FDA UDI
    Seaspine Orthopedics Corporation·10889981040765·Screw - Self-Drilling - 3.5x16mm

    AUDICOR SENSOR-ADAPTER MODEL AUDICOR SENSOR-ADAPTER 4.0

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MONARC SLING SYSTEM

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

    *

    FDA Adverse Event
    Malfunction ·MEDTRONIC·Product code DTB·May 9, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 26, 2014

    SPRINT QUATTRO SECURE S

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·June 14, 2011

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Enforcement
    Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

    Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Model Number (REF): 782107. 3. Model Number (REF): 782136. 510(k) Numbers: K213516, K223458, K230972, K232030, K251397, K251808

    FDA Recall
    Open, Classified ·Philips North America·Product code LNH·April 14, 2026

    Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Number (REF): 782103. 510(k) Numbers: K163116, K173079, K183063, K193215, K213516, K213583, K223458, K251397, K251808

    FDA Recall
    Open, Classified ·Philips North America·Product code LNH·April 14, 2026

    Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Model Number (REF): 782107. 3. Model Number (REF): 782136. 510(k) Numbers: K213516, K223458, K230972, K232030, K251397, K251808

    FDA Enforcement
    Class II ·Ongoing·Philips North America·May 6, 2026

    Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Number (REF): 782103. 510(k) Numbers: K163116, K173079, K183063, K193215, K213516, K213583, K223458, K251397, K251808

    FDA Enforcement
    Class II ·Ongoing·Philips North America·May 6, 2026

    ARGENT SURGICAL SYSTEMS***BIOPSY Punches*** Disposable manual instrument for skin biopsy.

    FDA Enforcement
    Class II ·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013