BEUDAMED
    16 results · 21ms · Sources: EU EUDAMED, US FDA

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    Lucero Medical Cervical Cage System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    n/a

    FDA UDI
    HANS RUDOLPH, INC.·00874750007387·3813 HTR SHELL/CABLE/CIRC CONN

    iCAP Imaging Cap

    FDA UDI
    Nova Eye, Inc.·00893872001028·Imaging Cap

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180102811·MONOPOLAR RF-CABLE WITH MALE BANANA (4 MM DIA.)...

    OPART, MODEL MRT-600

    FDA 510(k)
    FDA Class 2 ·Radiology

    Senhance Surgical System

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

    36MM 12/14 TPR FEM HD STD NK

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code LPH·August 29, 2018

    OLYMPIA STEM SIZE 5 RIGHT

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code LPH·August 29, 2018

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FKX·October 24, 2014

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·July 1, 2013

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·June 24, 2015

    Dexcom G4 PLATINUM Receiver with Share Receiver Part Number: MT22495 Receiver (mg/dL), Black; MT22495-PNK, Receiver (mg/dL), Pink; MT22495-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.

    FDA Enforcement
    Class I ·Terminated·Dexcom Inc·April 20, 2016

    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

    Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.

    FDA Enforcement
    Class II ·Terminated·Bayer Corp·June 11, 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