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

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    Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo, Agilia USB Cable

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Intellijet

    FDA UDI
    Smith & Nephew, Inc.·00885556603352·INTELIJET HERMES RDY PUMP SW

    Memory Vessel Probe 14cm 2.5mm nitinol wire, green alu handle

    FDA UDI
    Geister Medizintechnik GmbH·04057034046159·Memory Vessel Probe 14cm 2.5mm nitino...

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319706282·Williger Elevator 6-1/4" (15.6cm), 4mm sharp bl...

    GLOBAL UNITE

    FDA UDI
    DEPUY (IRELAND)·10603295451761·GLOBAL UNITE FX REVERSE SHOULDER ARTHROPLASTY P...

    HL 568 SELF MONITORING BLOOD GLUCOSE SYSTEM, HL 568BA SELF-MONIROTING BLOOD GLUCOSE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MODEL 455GE PHASED ARRAY WRIST COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    Widex

    FDA UDI
    Widex A/S·05706069691825·Widex BEYOND B-F2 (Midnight black ) 110, Teleco...

    HEATER-COOLER SYSTEM 3T

    FDA Adverse Event
    Malfunction ·LIVANOVA DEUTSCHLAND·Product code DWC·July 8, 2020

    PROXIMATE ILS CURVED CIR STAPL

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC·Product code GDW·October 22, 2008

    APOLLO

    FDA Adverse Event
    Other ·DRAGER MEDICAL GMBH·Product code BSZ·July 29, 2011

    SPACE PUMP IV SET

    FDA Adverse Event
    Malfunction ·B. BRAUN OF DOMINICAN REPUBLIC·Product code FPA·June 27, 2013

    UNKNOWN CATHETER

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROSURGERY·Product code JXG·February 28, 2019

    UNKNOWN STRATA VALVE/SHUNT

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROSURGERY·Product code JXG·February 28, 2019

    UNKNOWN STRATA VALVE/SHUNT

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROSURGERY·Product code JXG·February 28, 2019

    HEATER-COOLER SYSTEM 3T

    FDA Adverse Event
    Malfunction ·LIVANOVA DEUTSCHLAND·Product code DWC·September 29, 2021

    DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatomy Model Number : 712204

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·April 19, 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

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    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