BEUDAMED
    15 results · 21ms · 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 ×

    MISONIX, INC., AUSS-7 ULTRASONIC SURGICAL ASPIRATOR SYSTEM

    FDA 510(k)
    FDA Unclassified ·Unknown

    MAS PLIF

    FDA UDI
    Nuvasive, Inc.·00887517200983·MAS PLIF Fixation Tap, 5.5mm

    Paltop

    FDA UDI
    PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108699791·Fully Guided Drill Ø3.25mm L25mm

    General Instruments

    FDA UDI
    ALPHATEC SPINE, INC.·00840180502112·PLIF/TLIF Rotating Disc Shaver/Distractor Combo...

    Tiche PTA Balloon Dilatation Catheter

    FDA UDI
    BrosMed Medical Co.,Ltd.·06958481477429·

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306814884·Rochester Pean Forceps, Curved, 30.5 cm

    Marina Medical

    FDA UDI
    MARINA MEDICAL INSTRUMENTS, INC.·00840306814280·Rochester Pean Forceps, Curved, 30.5 cm

    TEARAWAY INTRODUCER SHEATH

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DIMENSION CTNI FLEX REAGENT CARTRIDGE

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    RUSCH 100% SILICONE 2 WAY 3CC 8 FR

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code KOD·April 17, 2013

    SETROX S 45

    FDA Adverse Event
    Injury ·BIOTRONIK SE & CO. KG·Product code NVZ·April 18, 2011

    GE OEC 9800

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

    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

    Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/ urologic closed and minimally invasive procedures. It is inserted via a trocar sleeve and is used to prepare, coagulate and cut tissue.

    FDA Enforcement
    Class II ·Terminated·Instrumed International, Inc.·October 8, 2014