BEUDAMED
    16 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 ×

    SELF CATH CATHETER

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Bur PM2-70 80K steel Ø5.0x80 sterile

    FDA UDI
    Bien-Air Surgery SA·17630055513073·

    TISSUE FORCEPS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896049956·TISSUE FORCEPS

    NITANIUM® ARCHWIRES

    FDA UDI
    Ortho Organizers, Inc.·00190707065621·.012 Upper Coated Nitanium® Pro Form™ Archwires

    HONIGUM

    FDA 510(k)
    FDA Class 2 ·Dental

    MODIFICATION TO IMMULITE HERPES I & II IGG, MODEL L2KHS2 & L2KHS6

    FDA 510(k)
    FDA Class 2 ·Microbiology

    OXYGENATOR, CARDIOPULMONARY BYPASS

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTZ·July 15, 2015

    CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code KRH·May 8, 2013

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·September 19, 2014

    ECHELON* 60 ENDOPATH**

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·May 24, 2011

    MONOMAX VIOLET 1(4)150CM HRT48 LOOP(M

    FDA Adverse Event
    Malfunction ·B.BRAUN SURGICAL SA·Product code NWJ·June 4, 2019

    MONOMAX VIOLET 1(4)150CM HRT48 LOOP(M

    FDA Adverse Event
    Malfunction ·B.BRAUN SURGICAL SA·Product code NWJ·June 4, 2019

    BD WHITACRE SPINAL NEEDLE

    FDA Adverse Event
    Injury ·BECTON DICKINSON·Product code BSP·December 4, 2007

    Maquet Quadrox-ID Pediatric Diffusion Membrane Oxygenator with Bioline Coating; Part Number BEQ-HMOD-30000 For cardiac surgery in combination with a heart lung machine to oxygenate blood, remove carbon dioxide and adjust blood temperature.

    FDA Enforcement
    Class II ·Terminated·Maquet Cardiovascular Us Sales, Llc·December 31, 2014

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS30; b) 3.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS35; c) 4.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE TRACH TUBE , Product Code/List Number/Item Code 60PFSS40; d) 4.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS45; e) 5.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS50; f) 5.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS55

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

    CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).

    FDA Enforcement
    Class II ·Terminated·CME America, LLC·December 9, 2020