BEUDAMED
    19 results · 30ms · Sources: EU EUDAMED, US FDA

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    VBB SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    STARLED3 NX

    FDA UDI
    ACEM SPA·08050705890439·STARLED3 NX TROLLEY ABPS

    LOCATOR R-Tx

    FDA UDI
    Zest Anchors, LLC·00840481118128·LOCATOR R-Tx Abutment For Outlink 4.1mm Externa...

    Tasso+ Convenience Kit

    FDA UDI
    Tasso Inc.·00860006434557·Tasso+ convenience kit allows self-collection o...

    Kalitec Universal Instruments

    FDA UDI
    Kalitec Direct LLC·B07301K1106000·Tray, Base, 6", Arcamed

    GUTTA PERCHA POINTS

    FDA UDI
    DiaDent Group International·08806383504010·Gutta Percha Points is used to root canal filin...

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306803062·Hoyos Vertical Post

    VSI MICRO-INTRODUCER SETS (REGULAR, STIFFEN), MODELS 7197V-7209V, 7240V-7256V, 7259V, 7230V, 7231V, 7260V, 7274V

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OTIS -C PLUS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Apelo® / Apelo® MIS

    FDA UDI
    ATLAS SPINE, INC.·M68111060400000·Standard Head

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 10, 2024

    OCTRODE LEAD KIT, 60CM LENGTH

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL·Product code LGW·September 9, 2022

    THERAKOS CELLEX

    FDA Adverse Event
    Malfunction ·THERAKOS, INC.·Product code LNR·May 10, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 1, 2011

    VERSACARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·August 14, 2008

    Ultrasound Video Gastroscope, Model EG-3870UTK. The product is intended to be used in combination with the ultrasound scanning unit made by Hitachi Medical Corporation, and the PENTAX Medical video processor to provide images for observation, diagnosis, imaging, or therapy of the upper gastrointestinal tract from esophagus through duodenum.

    FDA Enforcement
    Class II ·Terminated·Pentax of America Inc·August 30, 2017

    Boston Scientific brand Nephroureteral Stent System. Contents: 1-8Fr percuflex catheter with stent and locking pigtail, 1-stiffening cannula and 1-luer cap with septum. REF/catalog no. 90-6885; model no. M001906885.

    FDA Recall
    Terminated ·Boston Scientific Corp·Product code GBO·June 25, 2004

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024