BEUDAMED
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    CELLAVISION DM1200 WITH THE BODY FLUID APPLICTION

    FDA 510(k)
    FDA Class 2 ·Hematology

    Oticon

    FDA UDI
    Oticon A/S·05707131167361·AGIL, ITC P PB DIR L BE

    Disposable Site Making & Implantation Kit, Sterile and Non Sterile, iX

    FDA UDI
    RESTORATION ROBOTICS, INC.·00850470007630·

    VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UHMWPE COMPONENTS IN THE GENESIS KNEE SYSTEM, THE GENESIS II KNEE SYS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ENTERIC INJECTION CATHETER WITH IRRIGATION

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

    ARSTASIS ACCESS SYSTEM

    FDA Adverse Event
    Other ·ARSTASIS INC.·Product code DYB·November 15, 2010

    ARSTASIS ACCESS SYSTEM

    FDA Adverse Event
    Malfunction ·ARSTASIS, INC.·Product code DYB·November 19, 2010

    ARSTASIS ACCESS SYSTEM

    FDA Adverse Event
    Other ·ARSTASIS, INC.·Product code DYB·November 22, 2010

    ARSTASIS ACCESS SYSTEM

    FDA Adverse Event
    Injury ·ARSTASIS, INC.·Product code DYB·November 1, 2010

    MINI TREK CORONARY DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code LOX·May 9, 2013

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·September 19, 2014

    8800

    FDA Adverse Event
    Malfunction ·GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE)·Product code JAA·May 23, 2011

    UNK - LOCKING/SET SCREWS: VIPER 2

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SàRL CH·Product code NKB·April 9, 2026

    Z1 Femoral Hip System, Product Number 611777612

    FDA Enforcement
    Class II ·Ongoing·Zimmer, Inc.·March 19, 2025

    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

    EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021

    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

    INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187 (added 7/15/2021)

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

    ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K084 (added 7/15/2021) e) K087 (added 7/15/2021)

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

    Hemodialysis Delivery System, Software Version 2.x.

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·November 17, 2021