7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PLEUR-EVAC(R) ADULT/PEDI DUAL COLL CHEST DRAIN SYS
FDA 510(k)
FDA Class 2
·General Hospital
OXYGEN, AIR, VACUUM AND NITROUS-OXIDE MALE CONN.
FDA 510(k)
FDA Class 1
·Anesthesiology
GENERAL SEMEN ANALYSIS (GSA) KIT
FDA 510(k)
FDA Class 2
·Hematology
SJM MASTERS SERIES COATED AORTIC VALVED GRAFT
FDA Adverse Event
Injury
·ST. JUDE MEDICAL PUERTO RICO, INC. (CS)·Product code LWQ·December 7, 2010
SENSOR ENLITE
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OZO·July 9, 2014
AUTOPULSE NIMH BATTERY
FDA Adverse Event
Malfunction
·ZOLL CIRCULATION, INC.·Product code DRM·December 14, 2012
Brand Name: PIEZON Bottle Product Name: PIEZON Bottle Model/Catalog Number: EG-111 Software Version: N/A Product Description: These bottles are sold empty and are filled by the user with water - in some cases small quantities of disinfectant solutions - for dental treatments. The bottle is pressurized on the device during use. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE
FDA Enforcement
Class II
·Ongoing·Electro Medical Systems SA·May 1, 2024