BEUDAMED
    19 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 ×

    BPS - Bone Fragment Fixation Plates, Screws and Washers

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Euro Tech Toothbrush

    FDA UDI
    SAFCO DENTAL SUPPLY CO.·10810063755543·Euro Tech Toothbrush, tapered oval head, adult ...

    Integra® Jarit®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780455639·Integra® Jarit® Cobb Style Osteotome, Straight

    N/A

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036037079·

    Preference

    FDA UDI
    CTL Medical Corporation·00841732152724·7.2mm Polyaxial Triple-lead screw 55mm Green

    devemed

    FDA UDI
    devemed GmbH·04061644031856·Papilla elevator 2.6 / 3.6 mm F-LINE | SL | dou...

    ceraMotion®

    FDA UDI
    DENTAURUM GmbH & Co.KG·J011250055200·ceraMotion® Zr Dentin D3, 20 g / dental ceramic...

    ceraMotion®

    FDA UDI
    DENTAURUM GmbH & Co.KG·J011250055400·ceraMotion® Zr Dentin D3, 40 g / dental ceramic...

    Evolve

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215002602·

    Preference 2

    FDA UDI
    SINTX Technologies, Inc.·M555287250055·ø7.2 Triple Lead Screw Assembly, 55mm

    GE DATEX-OHMEDA AESTIVA/5 MRI ANESTHESIA SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    OneStep Pediatric CPR Multi-Function Electrode

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    Reicodent

    FDA UDI
    devemed GmbH·04061644063512·Papilla elevator 2.6 / 3.6 mm COMFORT | SL | do...

    DORO (R)

    FDA Adverse Event
    Injury ·PROMED INSTRUMENTS GMBH·Product code HBL·November 6, 2014

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code MDS·September 9, 2011

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM

    FDA Adverse Event
    Malfunction ·ALLERGAN·Product code LTI·July 23, 2013

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    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

    Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020. Additional kits produced through February 19, 2020 were included.

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·February 26, 2020