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

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    Cios Alpha; Cios Flow

    FDA 510(k)
    FDA Class 2 ·Radiology

    ARTiC-L™ 3D Ti Spinal System with TiONIC™ Technology

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00643169791015·TRIAL 5251520 L 25 HT 15 DEG 20 ART

    ARTiC-L™ 3D Ti Spinal System with TiONIC™ Technology

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00763000086084·TRIAL 5251520 L 25 HT 15 DEG 20 ART

    Ophthalmic Forceps

    FDA UDI
    KATENA PRODUCTS, INC.·00841668111246·COLIBRI FORCEPS 0.12MM TITANIUM

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776209179·ROTATABLE ANVIL GRASPER WFLUSH PORT

    Azur Pushable Helical

    FDA UDI
    Microvention, Inc.·00810170017469·Azur

    Gold Anchor

    FDA UDI
    Naslund Medical AB·07340145701022·25G (0.5mm) 15 cm needle with 0.28x20 mm marker

    Ophthalmic Knife

    FDA UDI
    KATENA PRODUCTS, INC.·00841668101261·SWISS MODEL BLADE BREAKER

    Oscar 2

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GAMBRO POLYFLUX HEMODIALYZER, MODEL 6H

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    32MM MOD HEAD COCR STD NECK

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·April 9, 2026

    R SERIES DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·September 3, 2014

    ZIMMER PERIARTICULAR LOCKING TIBIAL PLATE

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code HRS·September 14, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 29, 2013

    RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·July 30, 2014

    HA Pins (DFS HA Cort Screw), Hoffman/Colles Pins (Colles CSER Sterile w/ Pin Kit) Item Nos: HAA60-09030 HAA60-09040 HAA60-10030 HAA60-10040 HAA60-11030 HAA60-11040 HAA60-11050 HAA60-12040 HAA60-12060 HAA60-13030 HAA60-13040 HAA60-13050 HAA60-13060 HAA60-13070 HAA60-14050 HAA60-14080 HAA60-14090 HAA60-15020 HAA60-15030 HAA60-15040 HAA60-15050 HAA60-15060 HAA60-16030 HAA60-16040 HAA60-16050 HAA60-16070 HAA60-16090 HAA60-17040 HAA60-17060 HAA60-17080 HAA60-18010 HAA60-18030 HAA60-18040 HAA60-18050 HAA60-18060 HAA60-18090 HAA60-20030 HAA60-20040 HAA60-20050 HAA60-20060 HAA60-20080 HAA60-20090 HAA60-22050 HAA60-22060 HAA60-25030 HAA60-25040 HAA60-25050 HAA60-25060 HAA60-30060 HAB60-09030 HAB60-10030 HAB60-10040 HAB60-11040 HAB60-11050 HAB60-12040 HAB60-12060 HAB60-13040 HAB60-13050 HAB60-13060 HAB60-14050 HAB60-15060 HAB60-16070 HAB60-16090 HAB60-17080 HAB60-18010 HAB60-18090 HAB60-20080 HAB60-20090 808200000 Product Usage: These devices are intended for osteosynthesis, external fixation of fractures or bone lengthening procedures.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·December 4, 2019