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

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    DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini Fragment LCP System)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PMT® Halo Systems

    FDA UDI
    PMT CORPORATION·00650551110767·HALO, 1203-5 VEST PED1, LAMBSWOOL LINER, 1211-1...

    N/A

    FDA UDI
    Smith & Nephew, Inc.·00817470009316·2.8MM HEX DRIVER

    Resolve® Ceramic

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K210151111·Resolve® Ceramic R018 UL 5-5 CS BC HK

    Resolve® Ceramic

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K210151811·Resolve® Ceramic M018 UL 5-5 CS BC HK

    Resolve® Ceramic

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K210151121·Resolve® Ceramic R018 UL 5-5 CS HK/MBT 4-5

    CONCIERGE GUIDING CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Straumann BoneCeramic

    FDA 510(k)
    FDA Class 2 ·Dental

    ACUVUE OASYS WITH HYDRACLEAR PLUS

    FDA Adverse Event
    Injury ·VISTAKON·Product code LPL·October 24, 2008

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·August 5, 2011

    FLOTRAC SENSOR

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES DR·Product code DRS·July 8, 2013

    MENTOR MEMORYGEL BREAST IMPLANT

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FTR·May 3, 2018

    ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017  S 2000 system 10441730  S 3000 system 10441701  S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015

    Allura system; System Code Description (Model Numbers): Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10 OR Table (722022, 722033), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper FD20 (722006, 722012, 722028), Allura Xper FD20 Biplane (722008, 722013), Allura Xper FD20 OR Table (722015, 722023, 722035), Allura Xper FD20 Biplane OR Table (722025), Allura Xper FD20/10 (722029), Allura Xper FD20/15 (722058), Allura Xper FD20/15 OR Table (722059), Allura Xper FD20/20 (722038), Allura Xper FD20/20 OR Table (722039);

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·June 3, 2026

    Veradius Unity with Software Release 2.1- Amobile, diagnostic X-ray imaging and viewing system. . Model Number: 718132

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 15, 2021

    smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·March 27, 2024

    paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·October 2, 2024

    Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device (Interventional Tool) intended to be used in combination with a Philips interventional X-ray system and 3DRA data.

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 22, 2026

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    Allura system; System Code Description (Model Numbers): Allura Xper FD10C (722001), Allura Xper FD10F (722002), Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper FD20 (722006, 722012, 722028), Allura Xper FD20 Biplane (722008, 722013), Allura Xper FD20 OR Table (722015, 722023, 722035), Allura Xper FD20 Biplane OR Table (722025), Allura Xper FD20/10 (722029), Allura Xper FD20/15 (722058), Allura Xper FD20/15 OR Table (722059), Allura Xper FD20/20 (722038), Allura Xper FD20/20 OR Table (722039), Cardio Vascular-Allura (722400);

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 27, 2026