BEUDAMED
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    MERIT EMBOLECTOMY CATHETER MODEL ASAP100

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PROFUNDA COOLEY CLAMP

    FDA UDI
    SONTEC INSTRUMENTS, INC.·B09921005690·PROFUNDA COOLEY CLAMP ANGLED CURVED JAW/SHANK A...

    HS Stand. Burr, Ø4.0x70, 80k

    FDA UDI
    Bien-Air Surgery SA·17630055507102·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450413401·

    KSEA UNIVERSAL LAPAROMAT LAPAROSCOPIC SUCTION AND IRRIGATION PUMP

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

    DURASPAN HEMODIALYSIS LONG-TERM CATHETER

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

    ACCU-CHEK ® SPIRIT

    FDA Adverse Event
    Injury ·ROCHE DIABETES CARE AG·Product code LZG·May 8, 2013

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 19, 2014

    TERUMO CDI 100 MONITOR

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTY·May 13, 2011

    UNKNOWN TIBIAL BASEPLATE - MRH KNEE

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code KRO·October 23, 2025

    LATITUDE ELBOW ANATOMIC HUMERAL SPOOL SZ PETIT+ SIDE GAUCHE

    FDA Adverse Event
    Injury ·TORNIER INC·Product code JDC·May 7, 2024

    UNK - CONSTRUCTS: LCP RECONSTRUCTION PLATE/SCREWS

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code HRS·February 25, 2022

    UNK - PLATES: 3.5 MM LCP RECONSTRUCTION

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code HRS·February 25, 2022

    Powered Mobility Offers Versatility (M¿V)TM Chair. The Powered MOV Chair models EMS, EMS24, HHC, and INO Powered MOV Chair, enable two operators to transport a seated patient weighing up to 500 Ibs up or down stairs. Key features include infinite positioning system, thermal protection system, and locking casters. In addition to the aforementioned features, the battery powered track reduces operator effort and risk of back injury while transporting a patient up or down a set of stairs.

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·August 29, 2012

    HA FlexTrak II-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710008732

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·June 12, 2024

    IVEA Product Part Number 16100 Model 500A

    FDA Enforcement
    Class II ·Terminated·Firefly Medical, Inc.·October 11, 2017

    EMBLEM MRI S-ICD Model A219

    FDA Enforcement
    Class I ·Terminated·Boston Scientific Corporation·February 17, 2021

    CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).

    FDA Enforcement
    Class II ·Terminated·CME America, LLC·December 9, 2020

    Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.

    FDA Enforcement
    Class II ·Terminated·Bayer Corp·June 11, 2014

    Altrua 2 pacemaker, Models: a) S701 b) S702 c) S722

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·July 14, 2021