Search FDA 510(k) Database

6,807 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
14281–14304 of 174,061
Cleared Oct 02, 2021
Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids)
K201931 · GYC
Dixi Medical
Neurology · 446d
Cleared Oct 02, 2021
EYE-SYNC
K202927 · QEA
Syncthink, Inc.
Neurology · 368d
Cleared Oct 01, 2021
E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERS
K200011 · LPH
Microport Orthopedics, Inc.
Orthopedic · 638d
Cleared Oct 01, 2021
Surgimatix Absorbable Fixation System
K201934 · GDW
Surgimatix, Inc.
General & Plastic Surgery · 445d
Cleared Oct 01, 2021
STELLA BIO
K210002 · IPF
Egzotech Sp. Z O. O.
Physical Medicine · 270d
Cleared Oct 01, 2021
Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09
K210139 · DXN
Edan Instruments, Inc.
Cardiovascular · 255d
Cleared Oct 01, 2021
electrocardiograph: SE-1202
K210140 · DPS
Edan Instruments, Inc.
Cardiovascular · 255d
Cleared Oct 01, 2021
Medical Endoscope Image Processing System
K210270 · HIH
Jiangsu Jiyuan Medical Technology...
Obstetrics & Gynecology · 242d
Cleared Oct 01, 2021
HRSpheres Narrow-Size Embolic Microspheres
K210562 · KRD
Suzhou Hengrui Hongyuan Medical Co.,...
Obstetrics & Gynecology · 218d
Cleared Oct 01, 2021
Porous Patella and Porous Tibia Baseplate
K211221 · MBH
Smith & Nephew, Inc.
Orthopedic · 161d
Cleared Oct 01, 2021
D Camera Controller
K211332 · FET
Richard Wolf Medical Instruments...
Gastroenterology & Urology · 151d
Cleared Oct 01, 2021
Elekta Unity
K212114 · IYE
Elekta Solutions AB
Radiology · 86d
Cleared Oct 01, 2021
PENTAX Medical Auto Leakage Tester SHA-P6
K212201 · PCV
Pentax of America, Inc.
Gastroenterology & Urology · 79d
Cleared Oct 01, 2021
OSSDSIGN Cranial PSI
K212414 · PJN
Ossdsign AB
Neurology · 59d
Cleared Oct 01, 2021
Anthem Fracture System
K212433 · HRS
Globus Medical, Inc.
Orthopedic · 58d
Cleared Oct 01, 2021
Zenition 70
K212813 · OWB
Philips Medical Systems Nederland B.V.
Radiology · 28d
Cleared Oct 01, 2021
BRIUS Planner Software
K212828 · PNN
Brius Technologies, Inc.
Dental · 28d
Cleared Sep 30, 2021
Acuitas AMR Gene Panel
K191288 · PMY
Opgen, Inc.
Microbiology · 871d
Cleared Sep 30, 2021
Intravascular Administration Sets
K203609 · FPA
Baxter Healthcare Corporation
General Hospital · 294d
Cleared Sep 30, 2021
Implanova
K210523 · DZE
Dental Evolutions, Inc.
Dental · 219d
Cleared Sep 30, 2021
Small Bone Nailing System
K211439 · HTY
Skeletal Dynamics, Inc.
Orthopedic · 143d
Cleared Sep 30, 2021
Playboy 3 Contour Condom
K211450 · HIS
Thai Nippon Rubber Industry Public...
Obstetrics & Gynecology · 143d
Cleared Sep 30, 2021
NAEOTOM Alpha, Scan&GO
K211591 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 129d
Cleared Sep 30, 2021
Enteral Pump Syringe
K211593 · PNR
Jiangsu Caina Medical Co.,Ltd
Gastroenterology & Urology · 129d