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
193–216 of 483
Search insights Median review: 299d Top manufacturer: Centers For Disease Control and Prevention Lead specialty: Microbiology
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
Not Cleared May 11, 2020
NP Screen
DEN190031 · OJY
Advance Sentry Corporation
Microbiology · 322d
Not Cleared May 01, 2020
OGmend Implant System
DEN180065 · QAC
Woven Orthopedic Technologies, LLC
Orthopedic · 505d
Not Cleared May 01, 2020
iTEAR Neurostimulator
DEN190026 · QKV
Olympic Ophthalmics, Inc.
Ophthalmic · 352d
Not Cleared Apr 29, 2020
CARPEDIEM System
DEN180055 · QIR
Bellco Srl (Now Part of Medtronic, Inc)
Gastroenterology & Urology · 568d
Not Cleared Apr 16, 2020
MyCare Psychiatry Clozapine Assay Kit
DEN190028 · QKT
Saladax Biomedical, Inc.
Toxicology · 328d
Not Cleared Feb 25, 2020
iTind System
DEN190020 · QKA
Medi-Tate , Ltd.
Gastroenterology & Urology · 329d
Not Cleared Feb 21, 2020
AmplideX Fragile X Dx & Carrier Screen Kit
DEN190023 · OYV
Asuragen, Inc.
Medical Genetics · 309d