26 results
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42ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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DAVID One Step Home Use Pregnancy Test Midstream, DAVID One Step Home Use Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Cassette, DAVID One Step Home Use Pregnancy Test Cassette
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ZenFlex
FDA UDI
Kerr Corporation·00195062029776·Rotary Files
N/A
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K189551921·In-Ovation R RNC/BASE/EURO 018 UL5-5 CS-BC HK
IN-OVATION® Mini
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K191551811·IN-OVATION® mini EURO 018/5-5 CS HK
IN-OVATION® R
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K18955183U1·IN-OVATION® R EURO 018 U5-5 CS-1BC HK
IN-OVATION® R
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K18955183L1·IN-OVATION® R EURO 018 L5-5 CS-1BC HK
IN-OVATION® R
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K189551821·IN-OVATION® R EURO 018 UL/5-5 CS-BC HK
IN-OVATION® Mini
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K191551821·IN-OVATION® mini EURO 018/5-5 CBC HK
PACEMAKER HIGH-SPEED HANDPIECE MODEL PM-MQ, PM-M
FDA 510(k)
FDA Class 1
·Dental
TWIN NEUROTRAC-III
FDA 510(k)
FDA Class 2
·Neurology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 11, 2025
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 25, 2024
ATLAS II PLUS DR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D·Product code LWS·January 13, 2014
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 7, 2011
HOMECHOICE LOW RECIRCULATION VOLUME APD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 21, 2013
BD Q-SYTE¿ LUER ACCESS SPLIT-SEPTUM STAND-ALONE DEVICE
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FPA·June 4, 2019
IMPEDE-FX EMBOLIZATION PLUG
FDA Adverse Event
Malfunction
·SHAPE MEMORY MEDICAL INC.·Product code KRD·February 28, 2023
IMPEDE-FX EMBOLIZATION PLUG
FDA Adverse Event
Malfunction
·SHAPE MEMORY MEDICAL INC.·Product code KRD·May 7, 2024
IMPEDE-FX EMBOLIZATION PLUG
FDA Adverse Event
Malfunction
·SHAPE MEMORY MEDICAL INC.·Product code KRD·August 21, 2023
IMPEDE-FX EMBOLIZATION PLUG
FDA Adverse Event
Malfunction
·SHAPE MEMORY MEDICAL, INC.·Product code KRD·November 19, 2021