BEUDAMED
    17 results · 24ms · Sources: EU EUDAMED, US FDA

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    SYNTHES (USA) MEDIAL DISTAL TIBIA PLATES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TECOFLEX

    FDA UDI
    Gyrus ACMI, LLC·00821925006577·4.5FR(1.49mm) X 22-28cm QUADRA-COIL URETERAL ST...

    Preat Implant Prosthetics

    FDA UDI
    Preat Corporation·00842092179499·Biomet 3i Certain®-compatible 6.0mm Titanium Sc...

    Eagle Spectrum

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746000010·EAGLE SPECTRUM LIGHT CURE CARPULE KIT

    LIFEPAK® 15 monitor/defibrillator

    FDA UDI
    PHYSIO-CONTROL, INC.·00883873871812·15AABAABAABBBAAAAAAAAAAFLP15 MONITOR/DEFIB

    QUADRA COIL

    FDA Adverse Event
    Malfunction ·GYRUS ACMI·Product code FAD·November 20, 2009

    PARA 12 PLUS RETICS

    FDA 510(k)
    FDA Class 2 ·Hematology

    SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000

    FDA 510(k)
    FDA Class 2 ·Hematology

    WAVEWRITER ALPHA?

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·January 5, 2026

    DEXTRUS 4136

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

    COULTER LH 750 ANALYZER

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

    MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code MAF·February 20, 2008

    CLOSURE TOP

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET SPINE INC.·Product code NKB·June 12, 2023

    HERO GRAFT

    FDA Adverse Event
    Injury ·CRYOLIFE, INC.·Product code DSY·June 23, 2015

    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