BEUDAMED
    18 results · 26ms · Sources: EU EUDAMED, US FDA

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    Filters Regulation: Us FDA ×

    CardioCurve Steerable Sheath

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319706619·Converse Nasal Retractor 3-3/4" (9.4cm), size 4...

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197493611·360° Laminectomy Punch 40° an...

    NITRILE POWDER FREE PATIENT EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    6.0 X 5.7MM DENTAL IMPLANT

    FDA 510(k)
    FDA Class 2 ·Dental

    IN00087 CLERMONT FERRAND PH

    FDA Adverse Event
    Death ·SORIN GROUP ITALIA·Product code DWF·March 7, 2014

    INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT

    FDA Adverse Event
    Injury ·ALLERGAN (COSTA RICA)·Product code FTR·February 26, 2025

    DRILL BIT Ø2.7 CALIBR L210/185 3FLUTE

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HTW·August 29, 2013

    DRILL BIT Ø2.7 CALIBR L210/185 3FLUTE

    FDA Adverse Event
    Malfunction ·SYNTHES BETTLACH·Product code HTW·January 27, 2015

    INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code DTZ·January 7, 2016

    80 FRN

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

    I-STAT TROPONIN (CTNI) CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE CANADA LTD.·Product code MMI·May 9, 2011

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVY·July 8, 2013

    AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code FHW·October 14, 2020

    INSPIRE 6F HOLLOW FIBER OXYGENATOR

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·April 21, 2022

    INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL

    FDA Adverse Event
    Injury ·SORIN GROUP ITALIA·Product code DTZ·June 8, 2016

    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