BEUDAMED
    19 results · 31ms · Sources: EU EUDAMED, US FDA

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    EXACTECH BIOLOXDELTA / BIOLOX FEMORAL HEADS, 28MM OD, 32MM OD, 36MM OD, EXACTECH BIOLOX OPTION ADAPTERS/FEMORAL HEADS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EVOS Lumbar Interbody System

    FDA UDI
    Cutting Edge Spine, LLC·00841193108186·HA PEEK EVOS Straight, ,12mmx9mmx 22mm , FLAT ...

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694043304·Chin Plate 10mm with Screws, Sterile

    Precision MIS Bunion System

    FDA UDI
    Paragon 28, Inc.·00889795132581·Ø3.0mm Cannulated Drill for Ø4.0 Screw, Short

    HANKS' BALANCED SALTS (HBSS) 10X, NO. 210-3012

    FDA 510(k)
    FDA Class 1 ·Hematology

    GRYPHON T BR DS ANCHOR W/ORTHOCORD, GRYPHON T BR ANCHOR W /ORTHOCORD, GRYPHON P BR DS ANCHOR W/ORTHOCORD, GRYPHON P BR A

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    RAICHEM PHOSPORUS REAGENT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    WAVEWRITER ALPHA PRIME 16

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·December 9, 2024

    DISP SNAP Y SET, W/DISINFECT, W/DR BAG

    FDA Adverse Event
    Injury ·MEDISYSTEMS·Product code KDJ·March 16, 1998

    SPECTRA WAVEWRITER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·March 11, 2025

    INTELLIS

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·June 16, 2025

    INTERLOCKING DETACHABLE COIL

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - CORK·Product code KRD·May 9, 2013

    BONE SCREWS, CROSS-PIN, DIAM.2.0X14MM, (5/PACKAGE)

    FDA Adverse Event
    Malfunction ·STRYKER LEIBINGER FREIBURG·Product code JEY·September 19, 2014

    ARCHITECT C4000 ANALYZER

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING, INC.·Product code JJE·May 25, 2011

    Stryker CMF Customized Implant Kit X-Large; 5444-0-401 X-Large Implant (2) 5444-01-102 Host Bone; Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA. Designed individually for each patient to correct trauma and/or defects in mandibular, maxillofacial, or craniofacial bone.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·February 19, 2014

    Biomet Microfixation RapidFlap System 16MM RapidFlap SpinDown Clamp, 12 Pack Ref Number: 75-1030-12 Used for the re-attachment of the bone flap after a craniotomy.

    FDA Recall
    Terminated ·Zimmer Biomet, Inc.·Product code GXN·August 22, 2018

    Biomet Microfixation RapidFlap System 16MM RapidFlap SpinDown Clamp, 12 Pack Ref Number: 75-1030-12 Used for the re-attachment of the bone flap after a craniotomy.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·November 14, 2018

    Syringes with Fixed Needles labeled as: a) SOL-M: 1) SOL-M 1ml TB Syringe w/Fixed Needle 25G*5/8'', Model No. 181025, UPC 818392014884; 2) SOL-M 3ml Luer Lock Syringe w/Blunt Fill Needle 18G*1 1/2'', Model No. 1831815B, UPC 818392011593; 3) SOL-M 5ml Luer Lock Syringe w/Blunt Fill Needle 18G*1 1/2'', Model No. 1851815B, UPC 818392011609; 4) SOL-M 10ml Luer Lock Syringe w/Blunt Fill Needle 18G*1 1/2'', Model No. 1811815B, UPC 818392011616;

    FDA Enforcement
    Class II ·Ongoing·Sol-Millennium Medical Inc.·September 18, 2024

    TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021