BEUDAMED
    17 results · 22ms · Sources: EU EUDAMED, US FDA

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    Waterlase iPLus

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

    TWINFIX/DURABRAID

    FDA UDI
    Smith & Nephew, Inc.·03596010485670·TWINFIX TI 2.8SUTURE ANCHOR WITH 38

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319706596·Converse Nasal Retractor 3-3/4" (9.4cm), size 2...

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197493598·360° Laminectomy Punch 40° an...

    ARTHROCARE PARALLAX CONTOUR VERTEBRAL AUGMENTATION DEVICE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GLOBAL BY <GENX> BLASTOCYST MEDIA

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

    INDIGO SYSTEM ASPIRATION CATHETER 7D

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code QEW·August 3, 2022

    INDIGO SYSTEM ASPIRATION CATHETER 7D

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code QEW·August 20, 2022

    COLLEAGUE 3 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 20, 2008

    ACCU-CHEK SPIRIT COMBO

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·July 8, 2011

    ENERGEN

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

    INDIGO SYSTEM SEPARATOR 7D

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code QEW·September 13, 2022

    INFANT DUAL HEATED EVAQUA BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BZE·February 14, 2013

    CURRENT HEALTH MONITORING SYSTEM GEN 2 (G2)

    FDA Adverse Event
    Death ·CURRENT HEALTH LTD·Product code MSX·September 9, 2024

    INDIGO SYSTEM ASPIRATION CATHETER 7D

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code QEW·October 13, 2023

    ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens Medical Solutions USA, Inc. Ultrasound imaging systems.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·July 9, 2014

    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