BEUDAMED
    13 results · 20ms · Sources: EU EUDAMED, US FDA

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    JAZZ Suction Valve, JAZZ Air/Water Valve, JAZZ Forceps Valve

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    NA

    FDA UDI
    Smith & Nephew, Inc.·03596010588494·MTO TREPHINE DRILL 12MM (STERILE)

    PANALOK

    FDA UDI
    DEPUY MITEK, LLC·10886705000982·PANALOK Absorbable Anchor 3.5mm Size 1 (4 metri...

    SAFETYMATE TALKING FIRST AID

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    EUROSPITAL EU-TTG IGA UMANA

    FDA 510(k)
    FDA Class 2 ·Immunology

    QUANTUM MAVERICK MR BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LOX·March 29, 2007

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE CORPORATION·Product code KDI·October 29, 2014

    ANIMAS INSULIN CARTRIDGE

    FDA Adverse Event
    Injury ·ANIMAS CORPORATION·Product code LZG·August 12, 2011

    UNIFY QUADRA CRT-D, DF4 CONNECTOR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·July 8, 2013

    BD Blood Collection Assembly with Male Luer Lock, Catalog Number MBC6010

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Company·April 17, 2019

    ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual Touch IQ option; Model numbers: 10041461, 10440017 -S2000 system 10441730 -S3000 system VTIQ Option- 10439521 and 10439522 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

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    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