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
193–216 of 490
Search insights Median review: 299d Top manufacturer: Centers For Disease Control and Prevention Lead specialty: Microbiology
Not Cleared Mar 17, 2021
BioFire Respiratory Panel 2.1 (RP2.1)
DEN200031 · QOF
Biofire Diagnostics, LLC
Microbiology · 302d
Not Cleared Mar 05, 2021
ClearUP Sinus Relief
DEN200006 · QNU
Tivic Health Systems, Inc.
Ear, Nose, Throat · 392d
Not Cleared Mar 01, 2021
Analytic for Hemodynamic Instability (AHI)
DEN200022 · QNV
Fifth Eye, Inc.
Cardiovascular · 332d
Not Cleared Feb 26, 2021
Hominis Surgical System
DEN190022 · QNM
Momentis Surgical , Ltd.
General & Plastic Surgery · 681d
Not Cleared Feb 26, 2021
Q-Collar
DEN200017 · QNX
Q30 Sports Science, LLC
Physical Medicine · 344d
Not Cleared Feb 23, 2021
Lumenis Stellar M22
DEN200028 · QIU
Lumenis, Ltd.
Ophthalmic · 309d
Not Cleared Feb 05, 2021
eXciteOSA with remote and eXciteOSA without remote
DEN200018 · QNO
Signifier Medical Technologies
Dental · 318d
Not Cleared Dec 23, 2020
Helix Laboratory Platform
DEN190035 · QNC
Helix Opco, LLC
Medical Genetics · 509d
Not Cleared Dec 23, 2020
EndoRotor Device
DEN200016 · QNE
Interscope, Inc.
Gastroenterology & Urology · 282d
Not Cleared Dec 16, 2020
BEAR (Bridge-Enhanced ACL Repair) Implant
DEN200035 · QNI
Miach Orthopaedics, Inc.
Orthopedic · 195d
Not Cleared Nov 25, 2020
Parallel
DEN200029 · QMY
Mahana Therapeutics, Inc.
Gastroenterology & Urology · 209d
Not Cleared Nov 24, 2020
CADScor System
DEN190047 · QMW
Acarix A/S
Cardiovascular · 386d
Not Cleared Nov 20, 2020
FilmArray Global Fever Panel
DEN200043 · QMV
Biofire Defense, LLC
Microbiology · 147d
Not Cleared Nov 13, 2020
Acumen Assisted Fluid Management (AFM) Software Feature
DEN190029 · QMS
Edwards Lifesciences
Cardiovascular · 529d
Not Cleared Nov 06, 2020
NightWare Kit, Apple iPhone, Apple Watch, Apple iPhone Charging Cable, Apple...
DEN200033 · QMZ
Nightware, Inc.
Neurology · 163d
Not Cleared Sep 24, 2020
Tangible Boost
DEN200002 · QMM
Tangible Science, Inc.
Ophthalmic · 255d
Not Cleared Sep 18, 2020
Spineology Interbody Fusion System
DEN200010 · OQB
Spineology, Inc.
Orthopedic · 212d
Not Cleared Sep 17, 2020
HemosIL Liquid Anti-Xa
DEN190032 · QLU
Instrumentation Laboratory CO
Hematology · 450d
Not Cleared Sep 17, 2020
ToothWave™
DEN190039 · QMJ
Home Skinovations , Ltd.
Dental · 392d
Not Cleared Aug 28, 2020
Theranova Dialyzers, Theranova 400 Dialyzer, Theranova 500 Dialyzer
DEN190042 · QAX
Baxter Healthcare Corporation
Gastroenterology & Urology · 347d
Not Cleared Aug 07, 2020
Cell-Free DNA BCT
DEN200001 · QMA
Streck, Inc.
Chemistry · 210d
Not Cleared Jul 30, 2020
cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit
DEN200015 · QLX
Roche Molecular Systems, Inc.
Microbiology · 150d
Not Cleared Jun 15, 2020
EndeavorRx
DEN200026 · QFT
Akili Interactive Labs, Inc.
Neurology · 60d
Not Cleared May 22, 2020
NaviCam Capsule Endoscope System with NaviCam Stomach Capsule
DEN190037 · QKZ
Anx Robotica, Inc.
Gastroenterology & Urology · 283d