18 results
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28ms
·
Sources: EU EUDAMED, US FDA
binx health io CT/NG Assay
FDA 510(k)
FDA Class 2
·Microbiology
Integra® Miltex®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780418771·Integra® Miltex® Lempert Endaural Curette, 8-1/...
Sklar®
FDA UDI
SKLAR CORPORATION·10649111386480·TISSUE FCP FLUTED HDL 5.5" 1X2
IN-OVATION® Mini
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K191552811·IN-OVATION® mini EURO 022/5-5 CS HK
IN-OVATION® Mini
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807K191552821·IN-OVATION® mini EURO 022/5-5 CBC HK
In-Ovation ® Mini
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807191352101·IN-OVATION® mini Base Rx 022/LR5-22T -1A 4D HK
In-Ovation ® Mini
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807191352001·IN-OVATION® mini Base Rx 022/LR5-22T -1A 4D
In-Ovation ® Mini
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807191352801·IN-OVATION® mini EURO 022/LR5 -17T 2A
In-Ovation ® Mini
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D807191352811·IN-OVATION® mini EURO 022/LR5-17T 2A HK
In-Ovation ® Mini
FDA UDI
DENTSPLY SIRONA ORTHODONTICS INC.·D80719135200R1·IN-OVATION® mini Rhodium Base Rx 022/LR5-22T -...
TALON DISTALFIX PROXIMAL FEMORAL NAIL
FDA 510(k)
FDA Class 2
·Orthopedic
SOUNDSTAR 3D DIAGNOSTIC CATHETER, MODEL M-5723-05
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 21, 2025
GE OEC 9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·October 9, 2008
ACTIVA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·June 26, 2013
WAVELIGHT FS200 FEMTOSECOND LASER
FDA Adverse Event
Malfunction
·WAVELIGHT GMBH·Product code LZS·July 27, 2011
ZOLL IVTM ICY CATHETER
FDA Adverse Event
Malfunction
·ZOLL CIRCULATION INC·Product code NCX·February 7, 2024
Medtronic MiniMed(TM) Silhouette(TM) (MMT-377, 377T, 378, 378T, 384, 384T, 368, 368T, 381, 381T, 382, 382T, 383, 383T)
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·November 29, 2017