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
265–288 of 490
Search insights Median review: 299d Top manufacturer: Centers For Disease Control and Prevention Lead specialty: Microbiology
Not Cleared Sep 11, 2018
ECG App
DEN180044 · QDA
Apple, Inc.
Cardiovascular · 28d
Not Cleared Aug 23, 2018
MATRx plus
DEN170090 · QCJ
Zephyr Sleep Technologies
Dental · 245d
Not Cleared Aug 17, 2018
Brainsway Deep Transcranial Magnetic Stimulation (DTMS) System
DEN170078 · QCI
Brainways , Ltd.
Neurology · 322d
Not Cleared Aug 10, 2018
Natural Cycles
DEN170052 · PYT
Natural Cycles Nordic AB
Obstetrics & Gynecology · 324d
Not Cleared Jul 31, 2018
MolecuLight i:X
DEN180008 · QCR
Moleculight, Inc.
General & Plastic Surgery · 165d
Not Cleared Jul 20, 2018
Bonebridge
DEN170009 · PFO
Med-El Elektromedizinische Geraete GmbH
Ear, Nose, Throat · 522d
Not Cleared Jun 22, 2018
everlinQ endoAVF System
DEN160006 · PQK
Tva Medical, Inc.
Cardiovascular · 870d
Not Cleared Jun 22, 2018
Ellipsys Vascular Access System
DEN170004 · PQK
Avenu Medical, Inc.
Cardiovascular · 528d
Not Cleared Jun 12, 2018
DreaMed Advisor Pro
DEN170043 · QCC
DreaMed Diabetes, Ltd.
Chemistry · 299d
Not Cleared Jun 05, 2018
Curve Positive Airway Pressure System
DEN170089 · QBY
Fresca Medical
Anesthesiology · 173d
Not Cleared May 24, 2018
OsteoDetect
DEN180005 · QBS
Imagen Technologies, Inc.
Radiology · 108d
Not Cleared May 17, 2018
TrueTear Intranasal Tear Neurostimulator
DEN170086 · QBR
Allergan
Ophthalmic · 206d
Not Cleared May 07, 2018
Hemospray Endoscopic Hemostat
DEN170015 · QAU
Wilson-Cook Medical, Inc.
General & Plastic Surgery · 424d
Not Cleared Apr 26, 2018
Cala ONE
DEN170028 · QBC
Cala Health, Inc.
Neurology · 344d
Not Cleared Apr 20, 2018
LZI Carisoprodol Metabolite (Meprobamate) Enzyme Immunoassay
DEN170010 · QBK
Lin-Zhi International, Inc.
Toxicology · 423d
Not Cleared Apr 20, 2018
MALDI Biotyper CA System
DEN170081 · QBN
Bruker Daltonik GmbH
Microbiology · 203d
Not Cleared Apr 11, 2018
IDx-DR
DEN180001 · PIB
Idx, LLC
Ophthalmic · 89d
Not Cleared Apr 10, 2018
Precision Flow® HVNI
DEN170001 · QAV
Vapotherm, Inc.
Anesthesiology · 462d
Not Cleared Apr 03, 2018
Curetis Unyvero LRT Application
DEN170047 · QBH
Curetis GmbH
Microbiology · 204d
Not Cleared Mar 27, 2018
Dexcom G6 Continuous Glucose Monitoring System
DEN170088 · QBJ
Dexcom, Inc.
Chemistry · 109d
Not Cleared Mar 26, 2018
ThermoNeuroModulation Device, TNM Device
DEN170023 · QAR
Scion Neurostim, LLC
Neurology · 343d
Not Cleared Mar 19, 2018
PrimeStore MTM
DEN170029 · QBD
Longhorn Vaccines and Diagnostics, LLC
Microbiology · 299d
Not Cleared Mar 16, 2018
Acumen Hypotension Prediction Index (HPI) Feature Software
DEN160044 · QAQ
Edwards Lifesciences, LLC
Cardiovascular · 536d
Not Cleared Mar 06, 2018
23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)
DEN170046 · QAZ
23AndMe, Inc.
Pathology · 182d