BEUDAMED
    23 results · 21ms · Sources: EU EUDAMED, US FDA

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    CTXA Hip Bone Mineral Densitometer

    FDA UDI
    MINDWAYS SOFTWARE, INC.·B052DICTXAHIP0·The CTXA Hip Bone Mineral Densitometer (CTXA Hi...

    CTXA HIP; CTXA; QCT PRO CTXA HIP

    FDA 510(k)
    FDA Class 2 ·Radiology

    ADVANCE®

    FDA UDI
    Microport Orthopedics Inc.·M684K00271131·

    artVeneer life

    FDA UDI
    Merz Dental GmbH·D7092002113·artVeneer life lower posteriors, L, C3

    BetaForce™

    FDA UDI
    Ortho Organizers, Inc.·00190707124434·BETAFORCE Beta³ Euro Upper 016 (10pk)

    SCANLAN®

    FDA UDI
    SCANLAN INTERNATIONAL INC·00846159007831·Multi-Purpose Clamp

    BetaForce

    FDA UDI
    ORTHO TECHNOLOGY, INC.·00190730022028·Beta3 Euro Upper 016 10 archwires per pack

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112823·BARRON VACUUM PUNCH 9.25MM

    PROVEN KNEE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    IVC THREE BLASTOCYST MEDIUM, CAT # 2007

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    CRONIN SILASTIC BREAST IMPLANT

    FDA Adverse Event
    Injury ·DOW CORNING CORP.·Product code FTR·May 19, 1994

    HEYER-SCHULTEZ SALINE BREAST IMPLANT

    FDA Adverse Event
    Injury ·MENTOR CORP.·Product code FWM·May 19, 1994

    HEYER-SCHULTE SALINE BREAST IMPLANT

    FDA Adverse Event
    Injury ·MENTOR CORP.·Product code FWM·May 19, 1994

    INFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·March 13, 2013

    ACCU-CHEK FLEXLINK PLUS

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS, INC.·Product code FRN·February 4, 2011

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·February 20, 2008

    TECNIS SIMPLICITY

    FDA Adverse Event
    Malfunction ·AMO PUERTO RICO MFG. INC.·Product code HQL·August 14, 2024

    UNK

    FDA Adverse Event
    Malfunction ·APPLIED MEDICAL RESOURCES·Product code GCJ·September 4, 2019

    CORAIL AMT HIGH OFFSET NECK SEGMENT (KHO), Pro. Code L20433 Product Usage: The affected CORAIL Neck Trials are surgical instruments used in CORAIL total and partial hip arthroplasty.

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·April 17, 2019

    bk3000 Ultrasound System w/battery; Model No. 2300-66; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025