BEUDAMED
    17 results · 22ms · 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 ×

    LINA LOOP, MODELS: EL-160-4, EL-160-8, EL-200-4, EL-200-8

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

    MAS PLIF

    FDA UDI
    Nuvasive, Inc.·00887517201409·MAS PLIF Fixation Tap, 6.5mm

    Paltop

    FDA UDI
    PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108699814·Fully Guided Drill Ø4.2mm L25mm

    General Instruments

    FDA UDI
    ALPHATEC SPINE, INC.·00840180502136·PLIF/TLIF Rotating Disc Shaver/Distractor Combo...

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306814907·Rochester Pean (Kelly) Forceps, Straight: 35cm ...

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306814303·Rochester Pean (Kelly) Forceps, Straight: 35cm ...

    SPECTRA WAVEWRITER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·February 28, 2020

    VENTRICULAR ANALYSIS TOOLKIT OPTION

    FDA 510(k)
    FDA Class 2 ·Radiology

    ISCREEN VISION SCREENER

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·March 25, 2024

    ARTICULEZE M HEAD 36MM -2

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDI·April 22, 2013

    ZNN CMN NAIL 10MMX21.5CM 130R

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code HSB·April 18, 2011

    GE OEC 9600

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·July 9, 2008

    AGOGE PEDICLE SCREW SYSTEM

    FDA Adverse Event
    Malfunction ·ROYAL OAK MEDICAL DEVICES·Product code NKB·April 3, 2013

    Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x35 mm Catalog Number: 18965035S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.

    FDA Enforcement
    Class II ·Terminated·Stryker GmbH·June 24, 2020

    Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024

    Cocoon Convective Warming System, Product Code: CWS4000 (110V).

    FDA Enforcement
    Class II ·Terminated·Care Essentials Pty., Ltd.·February 12, 2020