BEUDAMED
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    ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772814800·GENUMEDI EXTRA WIDE SILVER SIZE VII

    PIN CUTTER

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896051539·PIN CUTTER FLUSH ENCLOSED DESIGN

    PMT CORPORATION - STEREOTACTIC

    FDA UDI
    PMT CORPORATION·00650551046356·TWIST DRILL BIT

    PMT Drill Cutter

    FDA UDI
    adeor Medical AG·04251388941119·

    LT3000 COMBO STIMULATOR, LT3001 TENS STIMULATORY, LT3002 EMS STIMULATOR

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    RESECTION ABLATOR

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SCREWDRIVER SHAFT, COMPRESSION T2 TIBIA 3.5 MM

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS KIEL·Product code HXX·July 27, 2012

    GII CR

    FDA Adverse Event
    Malfunction ·BROOKS MANUFACTURING SITE·Product code JWH·May 9, 2013

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE REHABILITATION EQUIP·Product code CAW·September 19, 2014

    FORCETRIAD

    FDA Adverse Event
    Malfunction ·COVIDIEN VALLEYLAB·Product code GEI·May 13, 2011

    BD BACTEC¿ MGIT¿ 960 SIRE KIT

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code MJA·September 24, 2025

    BD BACTEC¿ MGIT¿ 960 SIRE KIT

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code MJA·July 21, 2025

    BD BACTEC¿ MGIT¿ 960 SIRE KIT

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code MJA·July 21, 2025

    ACTIVA

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·August 15, 2018

    Sensis / Sensis Vibe systems with software version VD12 and equipped with HP Flex Pro-C PC. Diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies Model Numbers: Sensis Vibe Hemo 11007641 Sensis Vibe Combo 11007642 Sensis 10764561 Postprocessing Workstation 6648161 SIS Server 6648153

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·March 10, 2021

    Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U403-117); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U103-117); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U410-121); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U110-121)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Sensis/ Sensis Vibe Hemo systems with VD12A software as follows: Dedicated SIS Server- 6648153 Sensis Post-Processing Workstation- 6648161 Sensis- 10764561 VM Virtual Server- 10765502 Sensis High-End Servers- 10910620 Sensis Vibe Hemo- 11007641 Sensis Vibe Combo- 11007642 Sensis Vibe is a recording and procedure data management system for interventional cardiology, interventional radiology, surgical procedures performed in a hybrid OR and electrophysiology

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·April 28, 2021

    Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·November 6, 2024

    1. Sensis, material # 10764561; UDI: 04056869010137 2. Sensis Vibe Hemo, material # 11007641; UDI: 04056869010199 3. Sensis Vibe Combo, material # 11007642; UDI: 04056869010205 The Sensis recording system is a diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac, interventional Radiology, and surgical studies.

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·January 26, 2022