BEUDAMED
    17 results · 21ms · Sources: EU EUDAMED, US FDA

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    UCP DRUG SCREENING TEST CUPS

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    DD tempMED

    FDA UDI
    Dental Direkt GmbH·EDDIK110151·DD tempMED are pre-colored dental milling blank...

    Ni-Ti - Archwire

    FDA UDI
    ORMCO CORPORATION·00889989028430·NI-TI BROAD ARCH LOLGE 0190 0250 PK10

    Humelock II Cemented Shoulder System

    FDA UDI
    FX SOLUTIONS·03701037303009·HUMELOCK II LONG STEM TA6V SIZE 15 LG200 mm CEM...

    NA

    FDA UDI
    Stryker Leibinger GmbH & Co. KG·04546540490599·MINI PLATE, STRAIGHT, CONDENSED

    PENCAN®

    FDA Adverse Event
    Injury ·B BRAUN MELSUNGEN AG·Product code BSP·May 6, 2025

    MODIFICATION TO SYNERGY SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VITALSENS, AINGEAL, V-POD

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ACCU-CHEK ® SPIRIT

    FDA Adverse Event
    Malfunction ·ROCHE DIABETES CARE AG·Product code LZG·May 14, 2013

    GEMSTAR 7 THERAPY

    FDA Adverse Event
    Malfunction ·HOSPIRA HOLDINGS DE COSTA RICA LTD.·Product code FRN·September 16, 2014

    TRANSTAR STRETCHER

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FPO·April 25, 2011

    PENCAN®

    FDA Adverse Event
    Injury ·B BRAUN MELSUNGEN AG·Product code BSP·April 10, 2025

    PENTAX

    FDA Adverse Event
    Malfunction ·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code MNL·November 25, 2020

    TPRLC XR T1 PPS 14X148MM

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code KWZ·February 6, 2020

    Ultrasound Video Gastroscope, Model EG-3870UTK. The product is intended to be used in combination with the ultrasound scanning unit made by Hitachi Medical Corporation, and the PENTAX Medical video processor to provide images for observation, diagnosis, imaging, or therapy of the upper gastrointestinal tract from esophagus through duodenum.

    FDA Enforcement
    Class II ·Terminated·Pentax of America Inc·August 30, 2017

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012

    Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024