14 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM CYBERKNIFE VSI ROBOTIC RADIOSURGERY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
COMFORTGLIDE INTERMITENT CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VICTORY GUIDEWIRE (32 MODELS)
FDA 510(k)
FDA Class 2
·Cardiovascular
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·March 14, 2022
LINEAR ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 30, 2021
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 19, 2025
PELVILACE TO BIOURETHRAL SUPPORT SYSTEM
FDA Adverse Event
Injury
·C.R. BARD, INC. (COVINGTON)·Product code FTL·May 17, 2013
HEARTSTART FR3 ECG, BASIC BUNDLE, JAPAN
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·September 19, 2014
ASR ACETABULAR CUPS 56
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·June 3, 2011
DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
FDA Adverse Event
Injury
·COOK INC·Product code DQO·August 10, 2023
Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device during cleaning. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE
FDA Enforcement
Class II
·Ongoing·Electro Medical Systems SA·May 1, 2024
AQUAPAK 340 SW, 340 ML W/404 ADAPTOR. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.
FDA Enforcement
Class II
·Terminated·Teleflex Medical·February 18, 2015
cobas 6000 analyzer series Operators Manual Roche cobas; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014
Brand Name: ¿ cobas c 6000 MODULAR Series System e 601 ¿ cobas c 8000 MODULAR Series System - e 602 ¿ Roche / Hitachi MODULAR Analytics Combination System Model/Catalog/Part Number: MODULAR Analytics E 170 ¿ 03022109001 ¿ 03023109973 ¿ 03739040001 ¿ 03739040692 ¿ 05023572001 ¿ 05023599001 cobas e 601 module ¿ 04745922001 ¿ 04745922692 ¿ 05036348001 ¿ 05036348692 ¿ 05860652001 cobas e 602 module ¿ 05990378001 The Roche/Hitachi MODULAR Analytics System (E170) is a fully automated, random-access, software- controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. The cobas 6000 series (e 601) is a fully automated, random-access, software-controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in vitro determinations using a wide variety of tests. It is optimized for high throughput workloads in the professional environment using a combination of Ion selective electrodes (ISE), a photometric analysis unit an immunoassay analysis module. The cobas 8000 Modular Analyze Series (e602) is a fully automated system for Clinical chemistry analysis, intended for the in vitro qualitative and quantitative determination of analytes in body fluids. It is optimized for high throughput workloads in the professional environment using a combination of ion selective electrodes (ISE) and a photometric analysis unit.
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·January 24, 2018