BEUDAMED
    17 results · 25ms · Sources: EU EUDAMED, US FDA

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    HAC-300 HEAD ARRAY COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    Actril Cold Sterilant

    FDA UDI
    MEDIVATORS INC.·40677964016729·Actril Cold Sterilant

    TruForm

    FDA UDI
    Rmo, Inc.·00885797099648·MAX 1ST MOLAR RT&LT 100 BANDS

    Eagle No Drift

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746007743·EAGLE NO DRIFT MODIFIED SEALANT 6 GMS

    Eagle No Drift

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746061431·EAGLE NO DRIFT MODIFIED SEALANT 6 GMS

    LIFEPAK® 15 monitor/defibrillator

    FDA UDI
    PHYSIO-CONTROL, INC.·00883873871829·15AABAAABABBBAAAAAAAAAAFLP15 MONITOR/DEFIB

    THERMAGE THERMACOOL SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    ACME SPINE SYSTEM - SERIES 6000, 7000, MONOAXIAL AND POLYAXIAL SCREW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PRECISION SPECTRA

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 23, 2022

    DEXTRUS 4136

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO. KG·Product code NVN·March 13, 2013

    IMMAGE 800 IMMUNOCHEMISTRY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JQX·February 27, 2011

    ERBOTOM ICC 200 E/A

    FDA Adverse Event
    Injury ·ERBE ELECTROMEDIZIN GMBH·Product code GEI·February 20, 2008

    The product is refill heads for battery powered toothbrushes. Spinbrush Pro Whitening Medium Refills, UPC 7 66878 00194 4.

    FDA Recall
    Terminated ·Proctor & Gamble Co·Product code JEQ·November 11, 2004

    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

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

    OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b. OPTETRAK Logic PSC Tibial Inserts, Product Line 02-012-44-XXXX; c. OPTETRAK Logic CR Tibial Inserts, Product Line 02-012-47-XXXX; d. OPTETRAK Logic CR Slope + Tibial Inserts, Product Line 02-012-48-XXXX; e. OPTETRAK Logic CR Slope ++ Tibial Inserts, Product Line 02-012-49-XXXX; f. OPTETRAK Logic CRC Tibial Inserts, Product Line 02-012-51-XXXX; g. OPTETRAK Logic CC Tibial Inserts, Product Line 02-012-65-XXXX; Affected 510(k) numbers include: K033883, K132161, K093360, K110547, K111400, K121307, K123342, K150890. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018