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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    HOLOSCOPE-i

    FDA 510(k)
    FDA Class 2 ·Radiology

    NA

    FDA UDI
    Smith & Nephew, Inc.·03596010457103·PUTTI BONE RASP 266.7MM

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319706268·Cottle Periosteal Elevator 7-1/2" (18.8cm), sli...

    Memory Vessel Probe 14cm 1.5mm nitinol wire, blue alu handle

    FDA UDI
    Geister Medizintechnik GmbH·04057034046128·Memory Vessel Probe 14cm 1.5mm nitino...

    Surgical Direct

    FDA UDI
    Surgical Direct, Inc.·B382SD430602100720·6" Bipolar Forceps, Straight, Stainless Steel R...

    POWDER FREE PURPLE NITRILE EXAMINATION GLOVES, NONSTERILE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    VENOUS DRAINAGE CANNULA WITH DURAFLO COATING

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Maestro

    FDA UDI
    STRYKER CORPORATION·04546540555755·PD Series Angled Long "AM" Attachment

    Widex

    FDA UDI
    Widex A/S·05706069691313·Widex BEYOND B-F2 (Winter silver ) 110, Telecoi...

    1.0MM TI CABLE WITH CRIMP DOUBLE LEAD 470MM-STERILE

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code JDQ·December 18, 2015

    EGIA ULTRA UNIVERSAL SHORT STAPLER

    FDA Adverse Event
    Injury ·UNITED STATES SURGICAL·Product code GDW·August 3, 2011

    MCKAY DEE HSOP OGDEN UT 1

    FDA Adverse Event
    Malfunction ·Product code DTZ·July 31, 2008

    VITALITY 2

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 8, 2013

    CMD 20-1413 GLENOID IMPLANT

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code KWS·March 11, 2022

    DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatomy Model Number : 712204

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·April 19, 2023

    MEGADYNE Suction Coagulators, Product Code 004125 (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm)), Product Code 004225 (Suction Coagulator, Handswitching, 8 Fr, 6 inch (15.24cm), Product Code 004325 (Suction Coagulator, Handswitching, 12 Fr, 6 inch (15.24cm)), and Product Code 0041BN (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm), Bulk Non Sterile)

    FDA Enforcement
    Class II ·Ongoing·Megadyne Medical Products, Inc.·August 9, 2023

    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

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

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