BEUDAMED
    24 results · 24ms · Sources: EU EUDAMED, US FDA

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    SUTTER BIPOLAR FORCEPS - SUPERGLISS

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

    Pro-Link Ti

    FDA UDI
    Life Spine, Inc.·00190837080938·

    EVOS Lumbar Interbody System

    FDA UDI
    Cutting Edge Spine, LLC·00841193113111·HA PEEK EVOS Straight, ,12mmx11mmx 30mm , FLAT ...

    TALOS®-A

    FDA UDI
    SpineArt SA·07640375237408·TALOS®-A (HA) PEEK PLANAR, SYMMETRIC IBFD D24 ...

    TALOS® HA PEEK IBF

    FDA UDI
    MEDITECH SPINE, LLC·B167321310120·

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B167311310120·

    STILLE Osteotomes

    FDA UDI
    Stille AB·07332339206437·OSTEOTOME ORIGINAL STILLE 12 mm 16.5 cm 6.5 in

    V-TRUST HANDHELD PULSE OXIMETER MODEL: TD-8201

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ATTEST RAPID READOUT BIOLOGICAL INDICATOR FOR EO, MODEL 1294; ATTEST RAPID READOUT BIOLOGICAL INDICATOR FOR EO TEST PACK

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ACCELERATOR A3600

    FDA Adverse Event
    Malfunction ·INPECO SA·Product code JQP·December 20, 2024

    GORE EXCLUDER AAA ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES,INC·Product code MIH·October 15, 2012

    CAPSUREFIX

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 16, 2011

    PRIMEWIRE PRESTIGE PLUS

    FDA Adverse Event
    Malfunction ·VOLCANO CORPORATION·Product code DQX·May 16, 2013

    ASR ACETABULAR CUPS 52

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. - 8010379·Product code KWA·October 1, 2014

    VENTED AUTOFEED CHAMBER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·July 2, 2014

    MEDIHONEY CALCIUM ALGINATE WITH ACTIVE LEPTOSPERMUM HONEY. Model Numbers: (1) 31012, (2) 31022, (3) 31045. MEDIHONEY CALCIUM ALGINATE DRESSING WITH ACTIVE LEPTOSPERMUM HONEY supports and aids autolytic debridement and is indicated for the management of moderately to heavily exuding wounds

    FDA Recall
    Open, Classified ·Integra LifeSciences Corp. (NeuroSciences)·Product code FRO·January 16, 2026

    MEDIHONEY CALCIUM ALGINATE WITH ACTIVE LEPTOSPERMUM HONEY. Model Numbers: (1) 31012, (2) 31022, (3) 31045. MEDIHONEY CALCIUM ALGINATE DRESSING WITH ACTIVE LEPTOSPERMUM HONEY supports and aids autolytic debridement and is indicated for the management of moderately to heavily exuding wounds

    FDA Enforcement
    Class II ·Ongoing·Integra LifeSciences Corp. (NeuroSciences)·February 25, 2026

    Software: Syngo.via RT Image Suite software version VA30_SP02 with license T_RT_IMAGE_SUITE_PAT_MARK Intended Use: used as an advanced application on a SOM10 scanner SMN: 10496180

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·September 30, 2020

    syngo.via RT Image Suite with syngo.via VB30, VB40, VB50 and VB60- Intended for Radiation Therapy Treatment Material Number: 10496180

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·September 22, 2021

    Stryker PCD Precision System 13G Needle with Spineplex, sterile, single use, disposable , 4 units per box. units per box. Stryker Instruments, Kalamazoo, MI Part Number: 0505-585-000, Lot:11223012 13G Match Ground Four facet Tip Introduction Needle - PIN 0306-130-011 13G Bevel Tip Stylet - PIN 0306-131-012 The intended use of the Stryker PCD System is for mixing bone cement and delivering it percutaneously. Bone cement is mixed in the chamber then transferred directly into an extension nozzle which has been attached to the introduction needle in the fracture site by a luer lock fitting. Cement is then dispensed directly into the fracture site under fluoroscopy

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code JDZ·November 30, 2011