BEUDAMED
    19 results · 27ms · Sources: EU EUDAMED, US FDA

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    APTT-EA REAGENT, AN ELLAGIC ACID ACTIVATED REAGENT

    FDA 510(k)
    FDA Class 2 ·Hematology

    Barricade Coil System

    FDA UDI
    BALT USA LLC·00818053020506·Barricade Coil System (BCS) is intended for the...

    Master Series

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746099250·DB BRACKET MASTER SERIES MAND LEFT 2ND BICUSPID...

    CONLIN MOLAR BANDS

    FDA UDI
    Ortho Arch Company Inc·D90990004919·MOLAR BAND CONLIN RX LOWER LEFT 38

    Palladian™

    FDA UDI
    NEUROSTRUCTURES, INC·00841508106975·Cross Connector Gauge-Card

    Elite®

    FDA UDI
    Ortho Organizers, Inc.·00190707050429·.018 U7R (MC) MINI BUCCAL TUBE

    SUNI MAX

    FDA 510(k)
    FDA Class 1 ·Dental

    ATLAS IMPLANT SYSTEM- MINI PLUS

    FDA 510(k)
    FDA Class 2 ·Dental

    SMR HUMERAL HEAD D.50 H.16MM

    FDA Adverse Event
    Injury ·LIMACORPORATE SPA·Product code HSD·April 22, 2022

    SMR HUMERAL HEAD Ø40 MM

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code KWT·November 17, 2022

    DUOVISC

    FDA Adverse Event
    Injury ·ALCON - BELGIUM / ALCON N.V.·Product code LZP·May 27, 2014

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·November 8, 2010

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORP·Product code MKJ·December 26, 2012

    SMR REVERSE HUMERAL BODY SHORT

    FDA Adverse Event
    Injury ·LIMACORPORATE SPA·Product code KWS·April 5, 2019

    REVISION MOD. STEM Ø24MM

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code LZO·October 21, 2022

    Vereos PET/CT, Model No. 882446 Product Usage: Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem images anatomical cross-sections by computer reconstruction of X-ray transmission data. The PET subsystem images the distribution of PET anatomy-specific radiopharmaceuticals in the patient. The PET/CT system is used for the purposes of detecting, localizing, diagnosing, staging, re-staging, and follow-up for monitoring therapy response of various diseases in oncology, cardiology, and neurology. The system is intended to image the whole body, heart, brain, lung, gastrointestinal, bone, lymphatic, and other major organs for a wide range of patient types, sizes, and extent of diseases. Both subsystems can also be operated as fully functional, independent diagnostic tools, including application of the CT scanner for diagnosis and for use in radiation therapy planning.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·July 10, 2019

    Vereos PET/CT, Software version 2.0.1. Model Number: 882446 Product Usage: The Philips Vereos PET/CT system is a diagnostic imaging device that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem images anatomical cross-sections by computer reconstruction of X-ray transmission data. The PET subsystem images the distribution of PET anatomy-specific radiopharmaceuticals in the patient. The PET/CT system is used for the purposes of detecting, localizing, diagnosing, staging, re-staging, and follow-up for monitoring therapy response of various diseases in oncology, cardiology, and neurology. The system is intended to image the whole body, heart, brain, lung, gastrointestinal, bone, lymphatic, and other major organs for a wide range of patient types, sizes, and extent of diseases. Both subsystems can also be operated as fully functional, independent diagnostic tools, including application of the CT scanner for diagnosis and for use in radiation therapy planning.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·November 7, 2018

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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