8 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GIOTTO PATIENT BED
FDA 510(k)
FDA Class 2
·Radiology
N/A
FDA UDI
Tyber Medical, LLC·M695M9252120·
MYCOPLASMA PNEUMONIAE ANTIBODY EIA TEST SYSTEM
FDA 510(k)
FDA Class 1
·Microbiology
IMMITTANCE METER, MODEL AE-105D/S
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
TMJ BONE SCREW
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code JEY·January 22, 2013
SPRINT FIDELIS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·December 14, 2010
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 10, 2014
ENDURITY Pulse Generator REF PM**** SN ********* St. Jude Medical Cardiac Rhythm Assurity and Endurity pacemakers are intended to provide single-chamber or dual-chamber bradycardia pacing.
FDA Enforcement
Class I
·Ongoing·St. Jude Medical, Cardian Rhythm Management Division·May 19, 2021