BEUDAMED
    16 results · 28ms · 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 ×

    Zirconia Block

    FDA 510(k)
    FDA Class 2 ·Dental

    Brasseler USA

    FDA UDI
    Provision·00810041064912·

    Brasseler USA

    FDA UDI
    Provision·B504OMKM331250·

    Reprocessed Oscillating/Sagittal Saw Blade, Thick, 31 x 9 x 0.56mm

    FDA UDI
    SURETEK MEDICAL·B390KM331251·

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113905·VISCO INJECTION CANNULA 25GA

    SMALL BONE BLADES

    FDA UDI
    Peter Brasseler Holdings, LLC·00887919094234·KM33-125

    VK Couture

    FDA UDI
    Diversified Products, Inc.·00842894182932·

    NA

    FDA UDI
    STERILMED, INC.·10888551017084·SAW BLADE MICRO OSCILLATING 12 TEETH/CM STRYKE...

    WITHINGS BLOOD PRESURE MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HANDIVIPP

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    CLINITEK STATUS+

    FDA Adverse Event
    SIEMENS HEALTHCARE DIAGNOSTICS·Product code JIL·May 16, 2016

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE (SG)·Product code FRN·November 18, 2008

    LINOX S 65

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO. KG·Product code LWS·July 22, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 18, 2013

    Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the DIMMs (Dual In-line Memory Modules) used with affected systems. Allura Xper Model Name - Model Number: Allura Xper FD10 722003 722010 722026; Allura Xper FD10/10 722005 722011 722027; Allura Xper FD10C 722001; Allura Xper FD20 722006 722012 722028; Allura Xper FD20 Biplane 722008 722013; Allura Xper FD20 Biplane OR Table 722025; Allura Xper FD20 OR Table 722023 722035; Allura Xper FD20/10 722029; Allura Xper FD20/15 722058; Allura Xper FD20/20 722038; Allura Xper FD20/20 OR Table 722039; (Allura Centron - 722400 is impacted by this recall, but Allura Centron systems are not distributed in the United States.)

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 28, 2024

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025