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

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    Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard HQ Start-Up Kit, Thermogard HQ Start-Up Kit EX, Thermogard HQ Console

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    KeyPrint

    FDA UDI
    Keystone Industries·H66842200081·KeyOrtho IBT 1KG

    Zavation

    FDA UDI
    Zavation LLC·00842166132689·Ti3Z CIF 14mmx16mmx8mm -0 deg

    EVOS Lumbar Interbody System

    FDA UDI
    Cutting Edge Spine, LLC·00841193114965·HA PEEK EVOS Straight, ,8mmx8mmx 22mm , BICONVE...

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694053822·1.2mm Fast Flap Plate Organizer

    Ormco

    FDA UDI
    ORMCO CORPORATION·00889989044294·CROWN-PERM LL 8 1ST MOLAR SST PK/5

    PMT® Halo Systems

    FDA UDI
    PMT CORPORATION·00650551122746·HALO, 1220-5 VEST SMALL, LAMBSWOOL LINER, 1211-...

    Disposable Vinyl Glove

    FDA 510(k)
    FDA Class 1 ·General Hospital

    MEDLINE HIGH PRESSURE INJECTION TUBING

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TANDEM T: SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE INC.·Product code LZG·August 6, 2014

    RESTORE PRIME

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·August 9, 2011

    RIATA ST ACTIVE FIXATION

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·July 11, 2013

    Product is Reprocessed Ethicon Bladeless Trocars. Model: 35NLT, 35NST, 35OL

    FDA Recall
    Terminated ·Vanguard Medical Concepts, Inc·Product code NLM·March 17, 2006

    OPTICAL BIOMETER AL-Scan: Software Version: 1.09 and earlier. Ophthalmic: The OPTICAL BIOMETER AL-Scan is a measuring device that can measure as a single unit the values necessary to calculate the power of an IOL for cataract surgery such as axial length, corneal curvature radius, and anterior chamber depth. It measures these necessary values successively through a non-contact optical measurement method.

    FDA Enforcement
    Class II ·Terminated·Nidek Inc·August 24, 2016

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·June 21, 2022

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·May 23, 2022

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·September 2, 2022

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·March 15, 2022

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·March 15, 2022

    CHECK-IT

    FDA Adverse Event
    Malfunction ·LUCIRA HEALTH, INC.·Product code QJR·July 5, 2022