BEUDAMED
    21 results · 21ms · Sources: EU EUDAMED, US FDA

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    NextAR RSA Platform

    FDA 510(k)
    FDA Class 2 ·Neurology

    ENDOBUTTON

    FDA UDI
    Smith & Nephew, Inc.·00885554012293·ENDOBUTTON CL PAC, CONTAINS LATEX, STERILE

    Resolve® Ceramic

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

    TriplePlay

    FDA UDI
    DYMEDIX DIAGNOSTICS, INC.·00817377020964·Interface Cable, Perfect Fit Disposable Effort ...

    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

    Resolve® Ceramic

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K210152121·Resolve® Ceramic R022 UL 5-5 CS HK/MBT 4-5

    Resolve® Ceramic

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K210152811·Resolve® Ceramic M022 UL 5-5 CS BC HK

    Resolve® Ceramic

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K210152111·Resolve® Ceramic R022 UL 5-5 CS BC HK

    SFC VERTEBRAL BODY REPLACEMENT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Bright Bond Universal

    FDA 510(k)
    FDA Class 2 ·Dental

    KARDIAMOBILE

    FDA Adverse Event
    Malfunction ·ALIVECOR·Product code DPS·January 24, 2022

    GYNECARE X-TRACT MORCELLATOR

    FDA Adverse Event
    Malfunction ·ETHICON, INC.·Product code HET·October 20, 2008

    COULTER LH 750 HEMATOLOGY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·August 5, 2011

    ACUITY

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code OJX·July 8, 2013

    CURRENT HEALTH MONITORING SYSTEM GEN 2 (G2)

    FDA Adverse Event
    Death ·CURRENT HEALTH LTD·Product code MSX·September 9, 2024

    LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Cannulated. Thoracolumbosacral pedicle screw system; Spinal interlaminal fixation orthosis. Product sold as non-sterile and shipped in protective sterilization trays. Screws can also be shipped individually, as tray replenishments. Labeled as the following sizes: a. 5.5mm x 35mm; b. 5.5mm x 40mm; c. 5.5mm x 45mm; d. 5.5mm x 50mm; e. 5.5mm x 55mm; f. 6.5mm x 35mm; g. 6.5mm x 40mm; h. 6.5mm x 45mm; i. 6.5mm x 50mm; j. 6.5mm x 55mm; k. 6.5mm x 60mm; l. 7.5mm x 35mm; m. 7.5mm x 40mm; n. 7.5mm x 45mm; o. 7.5mm x 50mm; p. 7.5mm x 55mm; q. 7.5mm x 60mm; r. 8.5mm x 35mm; s. 8.5mm x 40mm; t. 8.5mm x 45mm; u. 8.5mm x 50mm; v.8.5mm x 55mm; w. 8.5mm x 60mm; Used in spinal fixation surgery.

    FDA Enforcement
    Class II ·Terminated·Integrity Implants Inc.·December 14, 2022

    ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens Medical Solutions USA, Inc. Ultrasound imaging systems.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·July 9, 2014

    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

    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