7 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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IMPRA FLEX GRAFTS (VARIOUS PRODUCT CODE NUMBERS)
FDA 510(k)
FDA Class 2
·Cardiovascular
INSTANT-VIEW H. PYLORI ONE STEP RAPID TEST
FDA 510(k)
FDA Class 1
·Microbiology
CHALLENGE 4010 ONE CHANNEL WIDE PULSE STIMULATOR
FDA 510(k)
FDA Class 2
·Physical Medicine
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 22, 2013
LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)
FDA Adverse Event
Injury
·ALLERGAN·Product code LTI·December 7, 2010
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·July 9, 2014
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