BEUDAMED
    20 results · 23ms · 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 ×

    KSEA MONOPOLAR VAPORIZATION ELECTRODES

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    HI-TORQUE ALL STAR

    FDA UDI
    ABBOTT VASCULAR INC.·08717648013812·HI-TORQUE ALL STAR Guide Wire .014 Straight Tip...

    MOBILE FLOSS 2 BRUSH FLOSS SMILE BUSINESS CARDS

    FDA UDI
    PRACTICON, INC.·00723896025420·Imprinted Business card containing an 11 yard c...

    ODYSSEY®

    FDA UDI
    Microport Orthopedics Inc.·M684K00174011·

    ODYSSEY®

    FDA UDI
    Microport Orthopedics Inc.·M684K00174031·

    Scanlan® SOFT GRIP™ Fabric Instrument Covers

    FDA UDI
    SCANLAN INTERNATIONAL INC·00846159001211·Scanlan® SOFT GRIP™ Fabric Instrument Covers - ...

    PedFuse®

    FDA UDI
    SPINEFRONTIER, INC.·00190361008699·PedFuse Respond, CNL, 9.0mm x 40mm

    ASAHI STERILE ACUPUNCTURE NEEDLE TYPE S

    FDA 510(k)
    FDA Class 2 ·General Hospital

    IDS5 IMAGE DISPLAY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code ODG·July 30, 2021

    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code ODG·July 24, 2021

    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code ODG·July 24, 2021

    EVOLUT FX DCS

    FDA Adverse Event
    Death ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·February 24, 2025

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Injury ·INSULET CORPORATION·Product code LZG·March 7, 2013

    ROTATING MULTIPLE CLIP APPLIER

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code FZP·February 25, 2011

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC·Product code NIQ·February 19, 2008

    Odyssey Femoral Holder/Driver, Part Number K001-7410, Non-sterile, 1 each, Wright Medical Technology, Inc., 5677 Airline Road, Arlington, TN 38002

    FDA Recall
    Terminated ·Wright Medical Technology Inc·Product code HWR·October 4, 2007

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: 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

    Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet system via a hose assembly. When wrapped around a limb and inflated, tourniquet cuffs apply an adequate amount of pressure on the arterial blood flow in a limb to create a bloodless surgical field. Tourniquet cuffs are available in a variety of sizes to accommodate a wide range of limb circumferences.

    FDA Enforcement
    Class II ·Terminated·Stryker Sustainability Solutions·November 9, 2016