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
313–336 of 490
Search insights Median review: 299d Top manufacturer: Centers For Disease Control and Prevention Lead specialty: Microbiology
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
Not Cleared Oct 28, 2016
BD MAX Vaginal Panel, BD MAX Instrument
DEN160001 · PQA
Geneohm Sciences Canada, Inc. (Bd...
Microbiology · 291d
Not Cleared Oct 06, 2016
APAS Compact with Urine Analysis Module
DEN150059 · PPU
Clever Culture Systems AG
Microbiology · 287d
Not Cleared Sep 26, 2016
Sensor Monitored Alimentary Restriction Therapy (SMART) Device
DEN150033 · ONY
Scientific Intake
Gastroenterology & Urology · 423d
Not Cleared Sep 16, 2016
Acclarent Aera Eustachian Tube Balloon Dilation System
DEN150056 · PNZ
Acclarent, Inc.
Ear, Nose, Throat · 284d
Not Cleared Sep 02, 2016
Modified Trevo ProVue Retriever, Trevo XP ProVue Retriever 4x20mm, Trevo XP...
DEN150049 · POL
Concentric Medical, Inc.
Neurology · 312d
Not Cleared Aug 22, 2016
ImPACT Computerized Neurocognitive Concussion Management Aid
DEN150037 · POM
Impact Applications, Inc.
Neurology · 377d
Not Cleared Aug 01, 2016
Nautilus BrainPulse 1000
DEN140040 · POP
Jan Medical, Inc.
Neurology · 587d
Not Cleared Jul 27, 2016
Permaseal
DEN150029 · PNQ
Micro Interventional Devices,Inc.
Cardiovascular · 401d