BEUDAMED
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    I-STAT 1 WIRELESS ANALYZER

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    I-STAT TROPONIN (CTNI) CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code MMI·February 8, 2023

    ILIZAROV

    FDA UDI
    Smith & Nephew, Inc.·23596010031963·BOLT FOR SMALL BONE FIXATOR 16MM

    BONE TAMP

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896082731·BONE TAMP BAYONET TIP

    PMT CORPORATION - STEREOTACTIC

    FDA UDI
    PMT CORPORATION·00650551147008·REDUCING TUBE FOR 3.2MM DRILL - NEUROMATE

    Endo Carry-On Procedure Kit

    FDA UDI
    MEDIVATORS INC.·00677964075131·Endo Carry-On Procedure Kit

    Endo Carry-On Procedure Kit

    FDA UDI
    MEDIVATORS INC.·00677964077401·Endo Carry-On Procedure Kit

    GREERTRACK SKIN TESTING SYSTEM, MODEL GT-IT, GT-IC

    FDA 510(k)
    FDA Class 2 ·General Hospital

    HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP)MIC SUSCEPTIBILITY PLATES

    FDA 510(k)
    FDA Class 2 ·Microbiology

    STEALTHSTATION S7 SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·May 9, 2013

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Death ·BAXTER HEALTHCARE CORPORATION·Product code KDJ·September 19, 2014

    CAPSURE Z NOVUS

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·May 25, 2011

    EVOLUT FX PLUS VALVE

    FDA Adverse Event
    Malfunction ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·July 24, 2025

    STEM: AMISTEM H 01.18.132 HA COATED STD STEM SIZE 2

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·July 7, 2022

    Oxygen Mask, Standard (Under the Lip) Infant, High Concentration Non-Rebreather, 7 ft. (2.1 m) Oxygen Tubing w/FITS-All Oxygen Connector Check Valve, Two Side Valves, Product Code 3266-E

    FDA Enforcement
    Class II ·Terminated·ConvaTec, Inc·June 14, 2017

    Cardio Medical Products, Inc. Defibrillation/Cardioversion/Monophasic or Biphasic Pacing/ECG Electrode Rx Only Single Patient Use Only Manufactured for Cardio Medical Products 385 Franklin Avenue, Suite L Rockaway, New Jersey 07866 www.cardiomedicalproducts.com (800) 227-3633 (973) 586-9624 FAX Defibrillator

    FDA Enforcement
    Class II ·Terminated·Cardio Medical Products·July 17, 2013

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

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

    The PrisMax System Version II Hemodialysis Delivery System: Automatic Repositioning System Pump Assembly, specifically tubing, Model Numbers: a) 955626 b) 955558 c) 955701 PrisMax V2 Preventive Maintenance Kit, Product Code SC616 ARPS PUMP, Product Code SC6035 ARPS Pump Assembly, Product Code SC6053

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·March 10, 2021

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021