BEUDAMED
    17 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 ×

    PROPHYflex 4

    FDA 510(k)
    FDA Class 1 ·Dental

    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

    Symetri Clear

    FDA UDI
    ORMCO CORPORATION·00889989084504·U1R SYMETRI CLEAR MCLAUGHLIN, BENNETT & TREVISI...

    IN-OVATION® R

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807K189110001·IN-OVATION® R TGO 020X028 UL/5-5 CS-BC HK

    NA

    FDA UDI
    Biedermann Motech GmbH & Co. KG·04250869642507·MOSS Ti Pedicle Screw, Ø10.0x110mm DL, polyaxia...

    Integra® Miltex®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780361428·Integra® Miltex® Bergh Cilia Forceps 3-1/2", Ja...

    ONE TOUCH ULTRA

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·May 21, 2002

    APNEA GUARD

    FDA 510(k)
    FDA Class 2 ·Dental

    SIUI CTS-900 DIGITAL ULTRASOUND IMAGING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    ADDITIONAL D MODULE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·November 28, 2007

    Specials

    FDA UDI
    Seaspine Orthopedics Corporation·10889981300951·Lollipop Trial, Anterior-Angled, 18mm x 11mm x ...

    Specials

    FDA UDI
    Seaspine Orthopedics Corporation·10889981301057·Lollipop Trial, Right/Down-Angled, 18mm x 11mm ...

    Specials

    FDA UDI
    Seaspine Orthopedics Corporation·10889981301002·Lollipop Trial, Right/Up-Angled, 18mm x 11mm x ...

    CARINO

    FDA Adverse Event
    Malfunction ·ARJOHUNTLEIGH POLSKA SP. ZO.O.·Product code FSA·October 14, 2014

    TOTAL ASR ACET IMP SIZE 54

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. - 8010379·Product code KWA·June 20, 2013

    UNKNOWN ZIMMER KNEE

    FDA Adverse Event
    Injury ·ZIMMER INC·Product code JWH·July 22, 2011

    Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026