BEUDAMED
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    GE LOGIQ P6/P6 PRO

    FDA 510(k)
    FDA Class 2 ·Radiology

    Endo Carry-On Procedure Kit

    FDA UDI
    MEDIVATORS INC.·00677964070372·The ENDO CARRY-ON Procedure Kit contains all of...

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111008238·TRAY PERF HI SIDE 10X6 1/2X 2"

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·June 10, 2020

    PERIPHERALLY INSERTED CENTRAL CATHETER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    FADASIS MEDICAL FM-1 NO BLENDER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    INFUSE BONE GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·January 5, 2018

    PICC NATE

    FDA Adverse Event
    Injury ·UTAH MEDICAL PRODUCTS, INC.·Product code LJS·January 12, 2007

    PICC NATE

    FDA Adverse Event
    Injury ·UTAH MEDICAL PRODUCTS, INC.·Product code LJS·January 12, 2007

    SINGLE NEEDLE BLOOD TUBING SET

    FDA Adverse Event
    Malfunction ·REYNOSA MANUFACTURING·Product code FJK·May 3, 2013

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code CBK·August 25, 2014

    ANTI-HUMAN GLOBULIN SOLIDSCREENII - DONOR

    FDA Adverse Event
    Malfunction ·BIO-RAD MEDICAL DIAGNOSTICS GMBH·Product code DEW·April 19, 2011

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code NKB·April 19, 2019

    BD INSYTE-A¿ ARTERIAL CATHETER

    FDA Adverse Event
    Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·January 5, 2023

    PICC-NATE

    FDA Adverse Event
    Injury ·UTAH MEDICAL PRODUCTS·Product code DQO·April 28, 2004

    Calcium Arsenazo, CALA-0250, For the Quantitative Determination of Total Calcium in Human Serum. The kit label shows CALCIUM ARSENAZO, CALA-0250, R: 12x20 mL. The vial's label shows CALCIUM ARSENAZO, CALA-5220, 20 mL, . CALCIUM ARSENAZO is intended use for the quantitative in vitro diagnostic determination of total calcium in human serum and plasma on ELITech Clinical Systems Selectra Pro Series Analyzers. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). It is not intended for use in Point of Care setting.

    FDA Enforcement
    Class II ·Terminated·SEPPIM SAS·November 13, 2013

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    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

    INVIVE CRT-P, Model Numbers: a) V172 b) V173 c) V182 d) V183 e) W172 f) W173

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