BEUDAMED
    24 results · 28ms · Sources: EU EUDAMED, US FDA

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    Bindex BI-2

    FDA 510(k)
    FDA Class 2 ·Radiology

    Redi Splint

    FDA UDI
    FARETEC, INC.·B54112113500·Redi Universal Splint, black, folded, 3.5x18

    Accufit

    FDA UDI
    Ortho Organizers, Inc.·00190707185497·AccuFit™ Molar Band UR7 - 35

    PMT® Halo Systems

    FDA UDI
    PMT CORPORATION·00650551136255·HALO, 1203-5 VEST X-LARGE, LAMBSWOOL LINER, 121...

    Votion

    FDA UDI
    ORTHO TECHNOLOGY, INC.·00190730007469·Votion 018 MC(0T) UR3 HK 0T 8A 0O (10PK)

    EXPERIENCE®

    FDA UDI
    Gc Orthodontics America Inc.·D78821135000201·EXPERIENCE Mini MBT 018/LL5-17T 2A

    EXPERIENCE®

    FDA UDI
    Gc Orthodontics America Inc.·D78821135000101·EXPERIENCE Mini ROTH 018/LL5-22T-1A 4D

    Votion®

    FDA UDI
    Ortho Organizers, Inc.·00190707113223·Votion .018 MC(0T) UR3 HK 0T 8A 0O (10PK) VOTION

    STARBAND CRANIAL ORTHOSIS

    FDA 510(k)
    FDA Class 2 ·Neurology

    MEDICAM EVOLUX, EVOSTAR, EVOLIGHT AND EVOLASE PULSED LIGHT SYSTEM

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

    ONE TOUCH BASIC

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·July 2, 2002

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·February 1, 2021

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 5, 2025

    T:SLIM X2 INSULIN PUMP

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code LZG·November 16, 2017

    I-STAT EC8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code CHL·October 13, 2021

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·October 22, 2008

    DUROM US ACETABULAR COMPONENT 52/46 L

    FDA Adverse Event
    Other ·ZIMMER GMBH·Product code KWA·July 1, 2011

    VITALITY 2

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 8, 2013

    Azurion 7 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722223, (2) 722224, (3) 722225, (4) 722226

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 28, 2024

    ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017  S 2000 system 10441730  S 3000 system 10441701  S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015