12 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EnteraLoc Flow
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776373474·5mm 36cm Spatula Monopolar Electrode, rear moun...
ELMED
FDA UDI
ELMED INCORPORATED·00842180138636·5MM 36CM INSULATED SPATULA REAR MOUNTED RF CONN...
MULTI-STRAP FULL FACE MASK
FDA 510(k)
FDA Class 2
·Anesthesiology
NIOX PANEL FOR USE WITH THE NIOX MINO AIRWAY INFLAMMATION MONITOR
FDA 510(k)
FDA Class 2
·Clinical Toxicology
BD ULTRA-FINE¿ PRO PEN NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON AND CO.·Product code FMI·February 25, 2022
ATLAS II HF CRT-D
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·November 10, 2008
MINICAP TRANSFER SET
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·August 25, 2011
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 12, 2013
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
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·October 16, 2024
Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor
FDA Enforcement
Class II
·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026