BEUDAMED
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    AFFIITY CP CENTRIFUGAL BLOOD PUMP

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Debakey Coarctation Clamp

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896122710·Debakey Coarctation Clamp Straight Atraumatic Jaw

    GELPI RETRACTOR

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896048850·GELPI RETRACTOR DEEP ANGLE TIPS

    IN-OVATION® C

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K100131101·IN-OVATION® C Base Rx 018 U3-3 CS HK

    IN-OVATION® C

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K100131611·IN-OVATION® C Roncone 018 U3-3 CS HK

    IND ONE STEP FECAL OCCULT BLOOD TEST MODEL 440-10

    FDA 510(k)
    FDA Class 2 ·Hematology

    NEMIO

    FDA 510(k)
    FDA Class 2 ·Radiology

    REMINGTON I-LIGHT HAIR REMOVAL SYSTEM

    FDA Adverse Event
    Injury ·SHASER INC·Product code ONF·May 21, 2021

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 28, 2025

    CADD CASSETTE RESERVOIRS - NON FLOW STOP

    FDA Adverse Event
    Malfunction ·ST PAUL·Product code FRN·May 6, 2022

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OYC·May 8, 2013

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 17, 2014

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    FDA Adverse Event
    Injury ·STAAR SURGICAL CO.·Product code MTA·May 17, 2011

    M2A-MAGNUM PF CUP 50ODX44ID

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·March 15, 2013

    M2A-MAGNUM MOD HD SZ 44MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·March 15, 2013

    M2A-MAGNUM 42-50 TPR INSRT STD

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·March 15, 2013

    LL100 CRYOSURGICAL

    FDA Adverse Event
    Malfunction ·COOPERSURGICAL, INC.·Product code GEH·August 4, 2023

    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

    Brainlab Cranial Navigation System: An Image Guided Surgery System / Stereotactic. Radiology Departments. The BrainLAB Cranial IGS System is intended to be an intra-operative image guided localization system to enable minimally invasive surgery.

    FDA Enforcement
    Class I ·Terminated·Brainlab AG·January 27, 2016

    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