BEUDAMED
    13 results · 20ms · Sources: EU EUDAMED, US FDA

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    JAMSHIDI STYLE BIOPSY NEEDLE (ACRI) (BIOMID), ILLINOIS STYLE BIOPSY NEEDLE (ISAN)

    FDA 510(k)
    FDA Class 2 ·Unknown

    Centrifuge Flex Module, TCA

    FDA UDI
    Thermo Fisher Scientific Oy·06438153007845·Centrifuge Flex Module is a module of TCAutomat...

    Instrument Case

    FDA UDI
    KATENA PRODUCTS, INC.·00841668111109·INSTRUMENT CASE DOUBLE ALUMINUM

    Ophthalmic Forceps

    FDA UDI
    KATENA PRODUCTS, INC.·00841668106280·HOFFER-MCPHERSON FORCEPS 1X2 TEETH

    Regular and Special Umbilical Cord Clamp and Cutter

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

    da Vinci SP Firefly Imaging System

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    VANGUARD SSK FEMORAL COMPONENT

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·August 20, 2018

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·February 9, 2013

    AED10

    FDA Adverse Event
    Malfunction ·WELCH ALLYN PROTOCOL, INC.·Product code MKJ·December 30, 2010

    ESSURE

    FDA Adverse Event
    BAYER PHARMA AG·Product code HHS·July 17, 2014

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND PLUS V FLANGE , Product Code/List Number/Item Code 67PFP40; b) PEDIATRIC TRACHEOSTOMY TUBE 4.5mm TTS FLEXTEND PLUS V FLANGE , Product Code/List Number/Item Code 67PFP45; c) PEDIATRIC TRACHEOSTOMY TUBE 5.0mm TTS FLEXTEND PLUS V FLANGE , Product Code/List Number/Item Code 67PFP50; d) PEDIATRIC TRACHEOSTOMY TUBE 5.5mm TTS FLEXTEND PLUS V FLANGE , Product Code/List Number/Item Code 67PFP55; e) PEDIATRIC TRACHEOSTOMY TUBE 6.0mm TTS FLEXTEND PLUS V FLANGE , Product Code/List Number/Item Code 67PFP60

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

    Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    Zeiss brand IOLMaster, Version 1-5, 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