BEUDAMED
    18 results · 22ms · 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 ×

    JETSTREAM NAVITUS L SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772777440·LUMBAMED PLUS FLEX PAD WM SILVER II

    JOBST soSoft

    FDA UDI
    BSN MEDICAL, INC.·00035664007478·SOSOFT 8-15 MM HG KNEE HIGH BROCADE LARGE SAND ...

    ARGENCO 883KF (5 dwt)

    FDA UDI
    ARGEN CORPORATION, THE·D818120242·Gold based noble metal

    N/A

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036031510·

    ResQPOD ITD 10, Military

    FDA UDI
    Zoll Medical Corporation·00847946028329·RESQPOD ITD 10, MILITARY

    ResQPOD ITD 10

    FDA UDI
    ADVANCED CIRCULATORY SYSTEMS INC·M5921202420000·The ResQPOD ITD 10 is indicated for the tempora...

    RESQPOD ITD 10

    FDA UDI
    Zoll Medical Corporation·00847946026929·ResQPOD ITD 10

    AUTO SUTURE ENDO CLIP III5MM CLIP ADAPTER

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    EMULATE FAST SET AND EMULATE REGULAR SET

    FDA 510(k)
    FDA Class 2 ·Dental

    TROJAN PLEASURE PACK LUBRICATED CONDOMS

    FDA Adverse Event
    Injury ·CHURCH & DWIGHT CO., INC.·Product code HIS·October 29, 2014

    LIFEPORT KIDNEY TRANSPORTER SYSTEM

    FDA Adverse Event
    Malfunction ·ORGAN RECOVERY SYSTEMS, INC.·Product code KDN·February 6, 2020

    IN TOUCH ZU

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·May 20, 2013

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·September 26, 2014

    AGILIS INTRODUCER, UNKNOWN

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, AF DIVISION·Product code DYB·June 7, 2011

    LKT200 Perfusion Circuit, part of Lifeport Kidney Perfusion Transporter KTR - Product Usage: The circuit is an accessory to LifePort Kidney Perfusion Transporter (KTR) Isolated kidney perfusion and transport system, which is intended to be used for the continuous hypothermic machine perfusion of kidneys for the preservation, transportation and eventual transplantation into a recipient.

    FDA Enforcement
    Class II ·Terminated·Organ Recovery Systems, Inc.·March 11, 2020

    Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format)  Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.)  Track interproximal decay progression over time  Patient education tool

    FDA Enforcement
    Class II ·Terminated·GA Industries·May 6, 2015

    Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024