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

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    CrossRoads Screw System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517639387·CoRoent Ant TLIF PEEK, 9x11x34mm 12°

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111386411·DRESSING FCP FLUTED HDL 5.5"

    In-Ovation ® Mini

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807191342001·IN-OVATION® mini Base Rx 022/LR4 -17T -1A 4D

    In-Ovation ® Mini

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807191342101·IN-OVATION® mini Base Rx 022/LR4 -17T -1A 4D HK

    In-Ovation ® Mini

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807191342801·IN-OVATION® mini EURO 022/LR4 -12T 2A

    In-Ovation ® Mini

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807191342811·IN-OVATION® mini EURO 022/LR4 -12T 2A HK

    In-Ovation ® Mini

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D80719134200R1·IN-OVATION® mini Rhodium Base Rx 022/LR4 -17T ...

    OSIRIX MD

    FDA 510(k)
    FDA Class 2 ·Radiology

    LIGHT GUIDE CABLE

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

    OSSURE LOEP KIT

    FDA Adverse Event
    Death ·AGNOVOS HEALTHCARE USA, LLC·Product code MQV·December 27, 2018

    OSSURE LOEP KIT

    FDA Adverse Event
    Death ·AGNOVOS HEALTHCARE USA, LLC·Product code MQV·January 18, 2020

    SPRINT QUATTRO SECURE S

    FDA Adverse Event
    Death ·MPRI·Product code LWS·June 26, 2013

    GE OEC 9600

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·October 9, 2008

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FKX·August 4, 2011

    XIA TITANIUM 4.5 BLOCKER

    FDA Adverse Event
    Malfunction ·STRYKER SPINE-US·Product code NKB·September 3, 2020

    Arthrex IBalance TKA Tibial Tray Size 2 - Catalog # AR-503-TTTC, Size 3 - Catalog # AR-503-TTTD, Size 4 -Catalog # AR-503-TTTE, Size 5 - Catalog # AR-503-TTTF, Size 6 - Catalog # AR-503-TTTG , Size 7 -Catalog # AR-503-TTTH, and Size 8 - Catalog # AR-503-TTTJ. Intended for implantation with bone cement, with the exception of the porous coated femoral components which can be used cemented or uncemented (biological fixation).

    FDA Enforcement
    Class II ·Terminated·Arthrex, Inc.·March 30, 2016

    TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems·October 10, 2018

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022