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
289–312 of 490
Search insights Median review: 299d Top manufacturer: Centers For Disease Control and Prevention Lead specialty: Microbiology
Not Cleared Mar 01, 2018
SkinPen Precision System
DEN160029 · QAI
Bellus Medical, LLC
General & Plastic Surgery · 604d
Not Cleared Feb 14, 2018
Banyan BTI
DEN170045 · QAT
Banyan Biomarkers, Inc.
Immunology · 170d
Not Cleared Feb 13, 2018
ContaCT
DEN170073 · QAS
Viz.Al, Inc.
Radiology · 137d
Not Cleared Dec 28, 2017
dermaPACE System
DEN160037 · PZL
Sanuwave, Inc.
General & Plastic Surgery · 521d
Not Cleared Dec 22, 2017
remOVE System
DEN160014 · QAG
Ovesco Endoscopy AG
Gastroenterology & Urology · 620d
Not Cleared Dec 21, 2017
AQUABEAM System
DEN170024 · PZP
Procept Biorobotics, Corporation
Gastroenterology & Urology · 248d
Not Cleared Dec 19, 2017
IlluminOss Bone Stabilization System
DEN160062 · QAD
Illminoss Medical, Inc.
Orthopedic · 356d
Not Cleared Dec 19, 2017
ContainOR
DEN170075 · PZQ
Advanced Surgical Concepts, Ltd.
General & Plastic Surgery · 81d
Not Cleared Nov 29, 2017
GeneSTAT.MDx Coccidioides Assay
DEN170041 · QAA
Dxna, LLC
Microbiology · 120d
Not Cleared Nov 24, 2017
FilmArray Respiratory Panel 2 plus (RP2plus)
DEN170017 · PZF
Biofire Diagnostics, LLC
Microbiology · 253d
Not Cleared Nov 15, 2017
NSS-2 System
DEN170018 · PZR
Innovative Health Solutions (Ihs), Inc.
Neurology · 243d
Not Cleared Nov 15, 2017
MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets):a...
DEN170058 · PZM
Memorial Sloan-Kettering Cancer Center
Pathology · 51d
Not Cleared Oct 27, 2017
VENTANA anti-MLH-1(M1) Mouse Monoclonal Primary Antibody, VENTANA anti-PMS2...
DEN170030 · PZJ
Ventana Medical Systems
Pathology · 150d
Not Cleared Sep 14, 2017
reSet
DEN160018 · PWE
Pear Therapeutics, Inc.
Neurology · 486d
Not Cleared Aug 18, 2017
ID-FISH Plasmodium Genus Test Kit, ID-FISH Plasmodium falciparum and P. vivax...
DEN160025 · PYN
Id-Fish Technology, Inc.
Microbiology · 417d
Not Cleared Jul 27, 2017
FETAL PILLOW
DEN150053 · PWB
Safe Obstetric Systems, Ltd.
Obstetrics & Gynecology · 617d
Not Cleared Jul 19, 2017
QuantX
DEN170022 · POK
Quantitative Insights, Inc.
Radiology · 103d
Not Cleared Jun 30, 2017
D2 Dressing
DEN160012 · POD
Z-Medica, LLC
General & Plastic Surgery · 471d
Not Cleared Jun 29, 2017
ClearLLab T1, ClearLLab T2, ClearLLab B1, ClearLLab B2, ClearLLab M
DEN160047 · PWD
Beckman Coulter
Immunology · 269d
Not Cleared Jun 21, 2017
Embosphere Microspheres
DEN160040 · NOY
Biosphere Medical, S.A.
Gastroenterology & Urology · 320d
Not Cleared Jun 01, 2017
Sentinel Cerebral Protection System
DEN160043 · PUM
Claret Medical, Inc.
Cardiovascular · 254d
Not Cleared May 18, 2017
Vitamin D 200M Assay for the Topaz System
DEN170019 · PSL
Ab Sciex, LLC
Chemistry · 59d
Not Cleared May 05, 2017
ARK Voriconazole II Assay Test System
DEN160033 · PUJ
ARK Diagnostics, Inc.
Toxicology · 294d
Not Cleared Apr 24, 2017
Oculeve Intranasal Tear Neurostimulator Device
DEN160030 · PQJ
Oculeve, Inc.
Ophthalmic · 291d