BEUDAMED
    15 results · 27ms · Sources: EU EUDAMED, US FDA

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    ZIMMER COLLAGEN REPAIR PATCH

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

    Premier SPRING PASTE FILLER

    FDA UDI
    PREMIER DENTAL PRODUCTS COMPANY·D6919053562·ROOT FILLER PKG 4 25MM 30

    JOBST forMen

    FDA UDI
    BSN MEDICAL, INC.·04042809844078·FOR MEN 30-40 MM HG KNEE HIGH OPEN TOE LARGE BL...

    Ophthalmic Forceps

    FDA UDI
    KATENA PRODUCTS, INC.·00841668106471·MANHATTAN E & E SUTURE FCPS W/ PLATFORM

    AURORA SYSTEM 1000 SERIES HOME SELF-CARE SINGLE PATIENT DELIVERY SYSTEM; MODELS- SYS 1000, L3 WITH N100 ARM, 4B SOFTWARE

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

    MODIFICATION TO CLASSIC GREAT TOE IMPLANT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AVIATOR ASSY TWO LEVEL PLATE SIZE 28

    FDA Adverse Event
    Injury ·STRYKER SPINE-FRANCE·Product code KWQ·October 17, 2016

    VITALITY 2

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 11, 2013

    E-POLY 36MM +3 MAXROM LNR SZ23

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code LZO·September 3, 2014

    CAPSUREFIX

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·April 13, 2011

    BIOMET 3i, PROVIDE PROTECTION CAP, Catalog # PPC484, PPC485, PPC654, and PPC655 BIOMET 3i Restorative Products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible. Provisional Abutments are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. They are intended for use to support a prosthesis in the mandible or maxilla for up to 180 days during endosseous and gingival healing, and are for non-occlusal loading of provisional restorations.

    FDA Enforcement
    Class II ·Terminated·Biomet 3i, LLC·January 13, 2016

    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

    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

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015