BEUDAMED
    18 results · 20ms · Sources: EU EUDAMED, US FDA

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    PURESPERM WASH

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Ball Burnisher 26-30

    FDA UDI
    COSMEDENT, INC.·D779100263014·

    Custom Procedure Kit

    FDA UDI
    MEDIVATORS INC.·40677964019782·The ENDO CARRY-ON Procedure Kit contains all of...

    Tablo Hemodialysis Concentrate

    FDA UDI
    Outset Medical, Inc.·00850001011105·Liquid acid concentrate, 45X, 1K, 2.5Ca, 1 U.S....

    Metal Custom Rx

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746104824·BRACKET V-SLOT MEDIUM TWIN MAX LEFT CUSPID 018 ...

    Medical Facets NC

    FDA UDI
    MEDICAL FACETS NC LLC·M933MDF20026300·3.0mm Cannulated Screw, Self-Drilling, Short Th...

    MODELS PRIAM (FAMILY OF DEVICES) DIGITAL IMAGING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    KSEA BIPOLAR COAGULATING ELECTRODES

    FDA 510(k)
    FDA Class 2 ·Neurology

    PRECISION FLX RMR 8.0MM DISP

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code HTO·April 10, 2018

    ONYX

    FDA Adverse Event
    Injury ·EV3 NEUROVASCULAR·Product code MFE·March 13, 2013

    INRATIO 2

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·February 8, 2011

    SENTINOL SELF-EXPANDING NITINOL BILIARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC·Product code FGE·February 8, 2008

    M2A 38MM MOD HD STD NK

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LZO·July 12, 2019

    RD118856

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·July 12, 2019

    G-PIN 2.8BL 3.2PL 60CM 2PK; 467265 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·June 27, 2018

    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

    Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names: MEDFUSION¿ 4000 Pump V1.0; MEDFUSION¿ 4000 Pump V1.1, v1.1.1, v1.1.2; MEDFUSION¿ 4000 Pump V1.1, V1.1.1, V1.1.2; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.6, V1.6.1 Product Usage: The pumps are indicated for the following uses: 1. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2. By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3. By the following delivery modes: continuous, volume/time, mass, body weight, intermittent and bolus.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·October 2, 2019

    Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly

    FDA Enforcement
    Class II ·Ongoing·Covidien·August 28, 2024