13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CAPNOSTREAM20P WITH HIFI C02 MONITORING
FDA 510(k)
FDA Class 2
·Anesthesiology
CATHETER CONNECTOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GE LOGIQ I, LOGIQ E AND VIVID E
FDA 510(k)
FDA Class 2
·Radiology
LINEAR ST
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·April 3, 2021
AFFIXUS HFN LAG SCREW
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HSB·May 29, 2019
UNKNOWN_KIE_PRODUCT
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS-KIEL·Product code HSB·May 22, 2013
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·September 26, 2014
ATTAIN STARFIX
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 14, 2011
BD LUER-LOK
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·January 24, 2025
BERLIN HEART IKUS STATIONARY DRIVING UNIT
FDA Adverse Event
Malfunction
·BERLIN HEART GMBH·Product code DSQ·December 9, 2022
HFN LAG SCREW 10.5MM X 110MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HSB·March 21, 2018
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
Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
FDA Enforcement
Class I
·Ongoing·Covidien·November 8, 2023