FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
16033–16056 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 04, 2021
IPL Hair Remover, Model: G993, G996, G998 and G885
K211368 · ONF
Shenzhen Mywin Technology Co., Ltd.
General & Plastic Surgery · 153d
Cleared Oct 04, 2021
Prelude Guide Sheath
K211405 · DYB
Merit Medical Systems, Inc.
Cardiovascular · 151d
Cleared Oct 04, 2021
Private Stock Labs Surgical Face Mask
K211425 · FXX
J.K. Private Stock, Inc.
General Hospital · 150d
Cleared Oct 04, 2021
RecoveryAir PRO
K211745 · IRP
Theragun, Inc.
Physical Medicine · 119d
Cleared Oct 04, 2021
EzDent-i/ E2/ Prora View/ Smart M Viewer
K211795 · LLZ
Ewoosoft Co., Ltd.
Radiology · 116d
Cleared Oct 04, 2021
Surgical Face Mask
K211899 · FXX
Hubei Yi-Ya Protective Products Co.,...
General Hospital · 105d
Cleared Oct 04, 2021
Dry DBM- A Putty
K212135 · MQV
Seaspine Corporation
Orthopedic · 88d
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