11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Fully Automatic Electronic Blood Pressure Monitor
FDA 510(k)
FDA Class 2
·Cardiovascular
ELMED
FDA UDI
ELMED INCORPORATED·00842180175051·FENCE BLADE, 4 × 8 Blade with hole
HEARTRAK SMART ECAT
FDA 510(k)
FDA Class 2
·Cardiovascular
VACPLUS SUCTION UNIT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 18, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 22, 2013
7900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·July 11, 2011
MIDAS REX MR8
FDA Adverse Event
Malfunction
·MDT POWERED SURGICAL SOLUTIONS·Product code HBC·May 9, 2025
PHOTOFIX PATCH - 6CM X 8CM
FDA Adverse Event
Injury
·CRYOLIFE, INC. - KENNESAW·Product code PSQ·January 12, 2021
MOTOR MR8 ELECTRIC
FDA Adverse Event
Malfunction
·MDT POWERED SURGICAL SOLUTIONS·Product code HBB·February 24, 2022
Cook Lead Clipper- An auxiliary tool indicated for use in patients requiring percutaneous retrieval of cardiac leads. Order Number (GPN): G20003 Reference Part Number (RPN): LR-CLP001
FDA Enforcement
Class II
·Ongoing·Cook Vandergrift, Inc.·September 13, 2023