FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Not cleared only ×
483 results
289–312 of 483
Search insights Median review: 299d Top manufacturer: Centers For Disease Control and Prevention Lead specialty: Microbiology
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
Not Cleared Apr 14, 2017
gammaCore Non-invasive Vagus Nerve Stimulator
DEN150048 · PKR
Electrocore, LLC
Neurology · 546d
Not Cleared Apr 12, 2017
Philips IntelliSite Pathology Solution
DEN160056 · PSY
Philips Medical Systems Nederland B.V.
Pathology · 132d
Not Cleared Apr 06, 2017
23andMe Personal Genome Service (PGS) Genetic Health Risk Test for Hereditary...
DEN160026 · PTA
23AndMe, Inc.
Hematology · 282d
Not Cleared Mar 27, 2017
ipsogen JAK2 RGQ PCR Kit
DEN160028 · PSU
Qiagen, Inc.
Pathology · 269d
Not Cleared Mar 04, 2017
CINtec Histology (50 tests), CINtec Histology (250 tests)
DEN160019 · PRB
Ventana Medical Systems, Inc.
Pathology · 285d
Not Cleared Feb 23, 2017
Accelerate Pheno system, Accelerate Phenotest BC Kit
DEN160032 · PRH
Accelerate Diagnotics
Microbiology · 227d
Not Cleared Feb 16, 2017
Companion
DEN140033 · POS
Lgch, Inc.
Neurology · 829d