BEUDAMED
    21 results · 18ms · Sources: EU EUDAMED, US FDA

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    VOCOM SILICONE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    ODYSSEY®

    FDA UDI
    Microport Orthopedics Inc.·M684K00144661·

    ODYSSEY®

    FDA UDI
    Microport Orthopedics Inc.·M684K00146261·

    artVeneer life

    FDA UDI
    Merz Dental GmbH·D7092001466·artVeneer life upper anteriors, BL, D3

    GRADIA®

    FDA UDI
    Gc America Inc.·D0470014661·GRADIA® DENTIN DA3

    GRADIA®

    FDA UDI
    Gc America Inc.·14548161392570·GRADIA® DENTIN DA3

    AuST Steerable Sheath

    FDA UDI
    CENTERPOINT SYSTEMS LLC·00810024670918·The AuST Steerable Sheath is intended for the i...

    URINE METHADONE (METH) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 93A

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    CD HORIZON ECLIPSE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VERCISE GENUS?

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code MHY·July 18, 2025

    QUATTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·March 5, 2013

    UNKNOWN ZIMMER HIP

    FDA Adverse Event
    Malfunction ·ZIMMER, INC.·Product code JDI·January 26, 2011

    ATEC VACUUM-ASSISTED BREAST BIOPSY DEVICE

    FDA Adverse Event
    Other ·HOLOGIC, INC. INTERVENTIONAL BREAST SOLUTIONS·Product code KNW·February 13, 2008

    LM Aculight Corporation Perseus Pulsed Fiber Laser, Model number: ML36L-1541. Additional Model numbers with non-defective type"A" fiber: M22L-1540, M27L-1541, M281-1540, M30PL-1541, & M33L-1541. Lockheed Martin Aculight, Bothell, WA, 98021. Pulsed laser energy generator intended for use as an OEM component for the LiDAR/Rangefinding, Surveillance, Mapping, and Sensing.

    FDA Recall
    Terminated ·Product code RDW·May 1, 2009

    Li-Ion battery used in the Oxus Portable Oxygen Concentrator (POC), RS-00400. Also branded as Reliability Plus byDrive. The Portable Oxygen Concentrator is intended to deliver concentrated oxygen for adult patients with chronic pulmonary diseases.

    FDA Enforcement
    Class II ·Terminated·Oxus America, Inc.·February 13, 2013

    Sunrise Brand Zippie Voyage, Chair with Casters, Early Intervention Device (Stroller), Model: EIZ14; Product is manufactured and distributed by Sunrise Medical (US) LLC., Fresno, CA. Used by a person to move from one place to another while sitting.

    FDA Enforcement
    Class II ·Terminated·Sunrise Medical (US) LLC·December 11, 2013

    STERRAD 100NX Sterilization System, P/N 10104 Product Usage: The STERRAD 100NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100NX process to inactivate microorganisms on a board range of medical devices and surgical instruments.

    FDA Enforcement
    Class II ·Terminated·Advanced Sterilization Products·April 10, 2013

    Xhibit Telemetry Receiver, Model: 96280

    FDA Enforcement
    Class II ·Ongoing·Spacelabs Healthcare, Inc.·August 17, 2022

    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

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013