BEUDAMED
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    KIMBERLY-CLARK CHILD/PEDIATRIC FACE MASK

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

    VACCESS LT LONG-TERM HEMODIALYSIS CATHETER

    FDA UDI
    Bard Access Systems, Inc.·00801741010644·VACCESS ST, 14.5 FR. 15cm

    NC TREK CORONARY DILATATION CATHETER

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR·Product code LOX·December 16, 2022

    Exact Medical Manufacturing, Inc.

    FDA UDI
    EXACT MEDICAL MANUFACTURING, INC.·00852205007809·Surgical Soft SMS Gown w/ Standard SMS Rein. Large

    SAV

    FDA UDI
    Diversified Products, Inc.·00037741210320·

    WIRE TWISTER NEEDLE HOLDER

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896051737·WIRE TWISTER WITH HOLE NEEDLE HOLDER STYLE GOLD...

    Orthopaedic Surgical Instruments

    FDA UDI
    CITIEFFE SRL·08056711921389·

    SAV

    FDA UDI
    Diversified Products, Inc.·00842894114308·

    SAV

    FDA UDI
    Diversified Products, Inc.·00842894122419·

    MR-GUIDE 2000

    FDA 510(k)
    FDA Class 2 ·Radiology

    CERAMICS2IN1

    FDA 510(k)
    FDA Class 2 ·Dental

    LINEAR ST

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 16, 2020

    TREK¿

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR INC.·Product code LOX·May 27, 2025

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·May 9, 2013

    UPHOLD VAGINAL SUPPORT SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·May 25, 2011

    PERFIX PLUG

    FDA Adverse Event
    Injury ·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·August 8, 2008

    TREK¿

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR INC.·Product code LOX·January 7, 2026

    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

    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