BEUDAMED
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    CIV-Clear cover

    FDA 510(k)
    FDA Class 2 ·Radiology

    Comprehensive® SRS

    FDA UDI
    Biomet Orthopedics, LLC·00880304540842·

    PMT® Halo Systems

    FDA UDI
    PMT CORPORATION·00650551112754·HALO, 1203-5 VEST LARGE, COOLMAX LINER, 1211-1 ...

    REUSABLE STIMULATING ELECTRODES

    FDA 510(k)
    FDA Class 2 ·Neurology

    AUTOMATED CORE BIOPSY DEVICE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    MANUAL ORTHOPEDIC SURGICAL INSTRUMENT

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK·Product code LXH·October 16, 2008

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·August 15, 2011

    GYNECARE TVT RETROPUBIC SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·July 8, 2013

    DISC ULNA 3X115MM RT W/BRNG C

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWT·June 20, 2018

    ALK (D5F3)

    FDA Adverse Event
    Malfunction ·VENTANA MEDICAL SYSTEMS INC.·Product code NJT·August 22, 2025

    COMPR SRS 60MM DST HUM BDY LT

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JDC·March 14, 2017

    UNKNOWN DISCOVERY HUMERAL CONDYLE KIT

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWS·June 20, 2018

    COMPR SRS 60MM DST HML BDY RT

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWS·June 20, 2018

    COMPR SRS MOD STEM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWS·June 20, 2018

    DEKA LIPOAI

    FDA Adverse Event
    Injury ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·August 4, 2025

    COMPR SRS IC SEG - 60MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWT·March 14, 2017

    ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017  S 2000 system 10441730  S 3000 system 10441701  S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015

    Model Number L211 PROPONENT DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    Allura system; System Code Description (Model Numbers): Allura Xper FD10C (722001), Allura Xper FD10F (722002), Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper FD20 (722006, 722012, 722028), Allura Xper FD20 Biplane (722008, 722013), Allura Xper FD20 OR Table (722015, 722023, 722035), Allura Xper FD20 Biplane OR Table (722025), Allura Xper FD20/10 (722029), Allura Xper FD20/15 (722058), Allura Xper FD20/15 OR Table (722059), Allura Xper FD20/20 (722038), Allura Xper FD20/20 OR Table (722039), Cardio Vascular-Allura (722400);

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 27, 2026

    Philips Azurion. System Code Description (Model Number): Azurion 3 M12 (722221, 722229), Azurion 3 M15 (722222, 722230), Azurion 5 (722281), Azurion 5 M12 (722227, 722231), Azurion 5 M20 (722228, 722232, 722281), Azurion 7 (722282), Azurion 7 B12 (722225, 722235), Azurion 7 B20 (722068, 722226, 722236), Azurion 7 M12 (722078, 722223, 722233), Azurion 7 M20 (722079, 722224, 722234, 722282).

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 20, 2026