BEUDAMED
    22 results · 20ms · 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.

    HVR PAIN RELIEF DEVICE

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111372056·MICRO TRAY 10.5 X 20 X 2.5

    NITINOL TC ELECTRODE

    FDA Adverse Event
    Malfunction ·COSMAN MEDICAL·Product code GXI·June 8, 2017

    REDON SET

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    THE UNI-CLIP STAPLE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NITINOL TC ELECTRODE

    FDA Adverse Event
    Malfunction ·COSMAN MEDICAL·Product code GXI·October 3, 2017

    INFINITI VISION SYSTEM

    FDA Adverse Event
    Malfunction ·ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER·Product code HQC·January 3, 2018

    LOCKSCR Ø5 L56 F/NAILS TAN LIGHT GREEN

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HWC·May 9, 2013

    INOVENT (DELVER SYSTEM)

    FDA Adverse Event
    Injury ·DATEX-OHMEDA/GE HEATLCARE·Product code MRN·August 28, 2014

    RESTORE ULTRA

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·May 11, 2011

    BD PLASTIPAK¿ HYPODERMIC SYRINGE WITH NEEDLE 3 ML - 21G 1 1/2 "

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON IND. CIRURGICAS LTDA·Product code FMF·September 5, 2017

    Distal Access Catheter: Model Numbers: 90121, 90130, 90131, 90160. The Distal Access Catheter is intended for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary and neuro vascular systems.

    FDA Recall
    Terminated ·Concentric Medical Inc·Product code DQY·September 26, 2013

    Trevo Pro 4 Stent Retriever, Model number 80021; U.S. Indications for use: The Trevo Retriever is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.

    FDA Recall
    Terminated ·Concentric Medical Inc·Product code NRY·November 13, 2013

    Zeiss brand IOLMaster 500, Model 500, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians and health care workers and may be only used under the supervision of a physician. This device will not be sold to the general public. The IOLMaster is intended for the biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec, Inc.·November 27, 2013

    Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000

    FDA Enforcement
    Class I ·Ongoing·Covidien·November 8, 2023

    IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil.

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec AG·December 9, 2015

    VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K084 (added 7/15/2021) e) K087 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    ACCOLADE DR SL (Model L301)

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