BEUDAMED
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    INFINITY MODULAR MONITORS WITH VF5 MODIFICATIONS (DELTA/KAPPA/DELTA XL/VISTA XL/GAMMA X XL AND SC 7000/8000/9000XL

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Wellell Inc.

    FDA registration
    Wellell Inc.·7 products·🇹🇼 Taiwan

    ANTERIOR CERVICAL PLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VIVANT BREAST LESION LOCALIZATION DEVICE

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

    2027971-2022-043439

    FDA Adverse Event
    Injury ·NOBEL BIOCARE USA, LLC·Product code DZE·February 21, 2022

    INTERSTIM II

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·April 9, 2013

    CONTAK RENEWAL 3 RF

    FDA Adverse Event
    Malfunction ·CARDIAC PACEMAKERS, INC·Product code NIK·May 8, 2008

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 7, 2011

    Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x40 mm Catalog Number: 18965040S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.

    FDA Enforcement
    Class II ·Terminated·Stryker GmbH·June 24, 2020

    ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F Stiffened Micro-Introducer Kit, 45CM SS/T ECHO B PG, Item Number H787065970465, Catalog No.REF 06597046, 2) 4 F Stiffened Micro-Introducer Kit, 45CM SS/T ECHO S PG, Item Number H787065970485, Catalog No. REF 06597048 Indicated for percutaneous introduction of guidewire or catheter into the vascular system following a small 21-gauge needle stick

    FDA Enforcement
    Class III ·Terminated·Angiodynamics, Inc.·December 28, 2016

    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