FDA 510(k) Regulatory Intelligence Search

Search devices, predicates, manufacturers and submission history used by regulatory affairs and medical device strategy teams.

174,883 clearances · 1976 to present · Updated monthly from FDA records

Filters: Not cleared only ×
474 results
289–312 of 474
Search insights Median review: 294d Top manufacturer: Centers For Disease Control and Prevention Lead specialty: Microbiology
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
Not Cleared Feb 14, 2017
FilmArray NGDS Warrior Panel
DEN160048 · PRD
Biofire Defense, LLC
Microbiology · 120d
Not Cleared Feb 06, 2017
Variola virus Real-Time PCR Assay
DEN160016 · PRA
Centers For Disease Control and...
Microbiology · 298d
Not Cleared Feb 03, 2017
SEEKER System
DEN150035 · PQW
Baebies, Inc.
Chemistry · 548d
Not Cleared Dec 21, 2016
AeroForm Tissue Expander System
DEN150055 · PQN
Airxpanders, Inc.
General & Plastic Surgery · 380d
Not Cleared Dec 21, 2016
CipherOx CRI Tablet
DEN160020 · PPW
Flashback Technologies, Inc.
Cardiovascular · 211d
Not Cleared Dec 20, 2016
Ultravision Visual Clearing System
DEN150022 · PQM
Alesi Surgical, Ltd.
General Hospital · 574d
Not Cleared Dec 19, 2016
Elecsys AMH, AMH CalSet, PreciControl AMH, AMH CalCheck 5
DEN150057 · PQO
Roche Diagnostics
Chemistry · 376d
Not Cleared Dec 19, 2016
Hem-Avert Perianal Stabilizer
DEN160005 · PNU
Stetrix, Inc.
Obstetrics & Gynecology · 326d
Not Cleared Dec 16, 2016
CleanCisionTM Wound Retraction and Protection System
DEN150038 · PQI
Prescient Surgical
General & Plastic Surgery · 491d