Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Not cleared only ×
490 results
97–120 of 490
Search insights Median review: 299d Top manufacturer: Centers For Disease Control and Prevention Lead specialty: Microbiology
Not Cleared Jan 12, 2024
Fibresolve
DEN220040 · QWO
Imvaria, Inc.
Radiology · 562d
Not Cleared Jan 12, 2024
DermaSensor
DEN230008 · QZS
Dermasensor, Inc.
General & Plastic Surgery · 344d
Not Cleared Jan 12, 2024
Osteoboost Belt
DEN230015 · QZO
Bone Health Technologies, Inc.
Orthopedic · 329d
Not Cleared Jan 11, 2024
BrainSee
DEN220066 · QWT
Darmiyan, Inc.
Neurology · 469d
Not Cleared Dec 22, 2023
BioTraceIO Lite
DEN230020 · QZL
Techsomed Medical Technologies , Ltd.
Radiology · 267d
Not Cleared Dec 15, 2023
Body Temperature Software (BTS)
DEN230050 · QZA
Fitbit, LLC
General Hospital · 151d
Not Cleared Dec 12, 2023
NaviCam ProScan
DEN230027 · QZF
Ankon Technologies Co., Ltd.
Gastroenterology & Urology · 242d
Not Cleared Dec 04, 2023
Sonu
DEN230045 · QZC
Sound Health Systems, Inc.
Ear, Nose, Throat · 171d
Not Cleared Nov 15, 2023
Simple 2 Test
DEN200070 · QYA
Letsgetchecked Inc. (Formerly...
Microbiology · 1094d
Not Cleared Nov 08, 2023
Dream Sock
DEN220091 · QYU
Owlet Babycare, Inc.
Cardiovascular · 329d
Not Cleared Nov 06, 2023
EasySep™ Human Bone Marrow CD138 Positive Selection Kit (100-0748)
DEN220090 · QYO
Stemcell Technologies Canada, Inc.
Pathology · 329d
Not Cleared Oct 12, 2023
ORi
DEN200076 · QWE
Masimo Corporation
Anesthesiology · 1025d
Not Cleared Oct 06, 2023
Edison System
DEN220087 · QGM
HistoSonics, Inc.
General & Plastic Surgery · 308d
Not Cleared Oct 04, 2023
DuraGraft
DEN230002 · QEJ
Marizyme, Inc.
Gastroenterology & Urology · 274d
Not Cleared Sep 29, 2023
Invitae Common Hereditary Cancers Panel
DEN210011 · QVU
Invitae Corporation
Medical Genetics · 914d
Not Cleared Sep 29, 2023
Procise IFX
DEN210056 · QXT
Procisedx, Inc.
Toxicology · 660d
Not Cleared Sep 29, 2023
Procise ADL
DEN220023 · QYD
Procisedx, Inc.
Toxicology · 543d
Not Cleared Sep 26, 2023
VasQ
DEN220026 · QVQ
Laminate Medical Technologies , Ltd.
Cardiovascular · 515d
Not Cleared Sep 13, 2023
ensoETM
DEN230021 · QXV
Advanced Cooling Therapy, Inc. D/B/A...
Cardiovascular · 167d
Not Cleared Sep 06, 2023
esolution
DEN230006 · QXU
S4 Medical Corp.
Cardiovascular · 225d
Not Cleared Sep 01, 2023
LightStrike+ (MXSUV1-SL and MXSUV1-FT)
DEN230007 · QXJ
Xenex Disinfection Services, Inc.
General Hospital · 212d
Not Cleared Aug 22, 2023
BrachyGel Vaginal Hydrogel Packing System
DEN220052 · QXR
Brachyfoam, Inc. D/B/A Advaray
Radiology · 362d
Not Cleared Aug 18, 2023
AXIOS Stent and Electrocautery-Enhanced Delivery System (10mm x 10mm Stent)
DEN230019 · QXH
Boston Scientific Corporation
Gastroenterology & Urology · 144d
Not Cleared Aug 16, 2023
Revi System
DEN220073 · QXM
Bluewind Medical , Ltd.
Gastroenterology & Urology · 315d