BEUDAMED
    19 results · 22ms · Sources: EU EUDAMED, US FDA

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    BIOMET GRAFT DELIVERY SYRINGES

    FDA 510(k)
    FDA Class 2 ·General Hospital

    INTREPED, Intraosseous Fusion Device

    FDA UDI
    Auxano Medical LLC·00850055649651·INTREPED 10 Universal Depth Stop

    Foot Osteotomy Wedge System

    FDA UDI
    Tyber Medical, LLC·M6951407100·CerviFuse Lordotic Spacer, 11 x 14 x 10mm

    Globe Scientific

    FDA UDI
    GLOBE SCIENTIFIC INC.·00840095604017·Microscope Cover Glass, 22mm x 32mm, # 1 Thickn...

    Universal Abutment

    FDA UDI
    BICON, LLC·00813110020857·Universal Abutment UA4 SP 0° - 2.0mm Post

    eTRAX™ Needle

    FDA UDI
    CIVCO MEDICAL INSTRUMENTS CO., INC.·10841436103227·Sterile needle, 14GA x 7cm with (7.6 tapered to...

    Meduloc Intramedullary Fracture Fixation (IFF) System

    FDA UDI
    MEDULOC, LLC·00810184540441·Machined Wire Pusher (2.0/2.5/3.0/3.5)

    TEGO NEEDLE FREE ACCESS ACCESS DEVICE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ROLL-X GUIDEWIRE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Ascend

    FDA UDI
    ALPHATEC SPINE, INC.·00190376665931·12mm Core EXP, 7°x10° 14-19mm

    Ascend

    FDA UDI
    ALPHATEC SPINE, INC.·00190376478081·12 mm EXPANDABLE CORE, 7°x10° 14-19 mm

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 12, 2024

    LRG TAP PRI MOD NCK 0DEG 34MM

    FDA Adverse Event
    Injury ·STRYKER ORTHOPAEDICS-MAHWAH·Product code MEH·May 31, 2013

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·October 3, 2014

    ECHELON*FLEX60 COMPACT

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·June 27, 2011

    ES2 CANNULATED MODULAR TAP

    FDA Adverse Event
    Malfunction ·STRYKER SPINE-FRANCE·Product code LXH·January 23, 2017

    GALAXY G3 4MM X 12CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·December 5, 2022

    C-Series High Energy Linear Accelerator - Models: Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clinac 2100 C/D, Clinac 2300C/D, Clinac 21EX, Clinac 23EX with versions 7, 8, 9 and 6 MV configuration and maximum dose rate of at least 6000 MU/min only. Varian High Energy Linear Accelerator is intended to provide sterotactic radiosurgery and precision radio-therapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·September 24, 2014

    C-Series: Clinac, Trilogy, Trilogy Tx. , Novalis high energy linear accelerators and UNIQUE single energy linear accelerator; Versions 7, 8 and 9. The UNIQUE is not sold in the US. Product Usage: The Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. The UNIQUE is a single energy medical linear accelerator. UNIQUE is indicated for precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·December 11, 2013