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
217–240 of 490
Search insights Median review: 299d Top manufacturer: Centers For Disease Control and Prevention Lead specialty: Microbiology
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
Not Cleared Feb 10, 2020
Surfacer Inside-Out Access Catheter System
DEN190038 · QJH
Bluegrass Vascular Technologies, Inc.
Cardiovascular · 179d
Not Cleared Feb 07, 2020
Caption Guidance
DEN190040 · QJU
Bay Labs, Inc.
Radiology · 164d
Not Cleared Dec 23, 2019
Mucosal Integrity Conductivity (MI) Test System
DEN180067 · QIS
Diversatek Healthcare, Inc.
Gastroenterology & Urology · 371d
Not Cleared Dec 13, 2019
Control-IQ Technology
DEN190034 · QJI
Tandem Diabetes Care, Inc.
Chemistry · 151d
Not Cleared Dec 12, 2019
GSP Neonatal Creatine Kinase - MM kit
DEN180056 · QJE
Perkinelmer, Inc.
Chemistry · 427d
Not Cleared Dec 05, 2019
cobas vivoDx MRSA
DEN190016 · QIV
Roche Molecular Systems, Inc.
Microbiology · 261d
Not Cleared Dec 02, 2019
WOUNDCHEK Bacterial Status
DEN180014 · QFA
Alere Scarborough, Inc.
Microbiology · 619d
Not Cleared Nov 20, 2019
EchoTip Insight Portosystemic Pressure Gradient Measuring System
DEN180062 · QIJ
Cook Ireland, Ltd.
Gastroenterology & Urology · 366d
Not Cleared Oct 10, 2019
OraQuick Ebola Rapid Antigen Test
DEN190025 · QID
OraSure Technologies, Inc.
Microbiology · 150d
Not Cleared Jun 07, 2019
IB-Stim
DEN180057 · QHH
Innovative Health Solutions (Ihs), Inc.
Neurology · 225d
Not Cleared May 23, 2019
Synovasure Alpha Defensin Lateral Flow Test Kit, Synovasure Alpha Defensin...
DEN180032 · QGN
Cd Diagnostics, Inc.
Microbiology · 328d
Not Cleared May 23, 2019
ZIKV Detect 2.0 IgM Capture ELISA
DEN180069 · QFO
InBios International, Inc.
Microbiology · 148d
Not Cleared May 20, 2019
Nerivio Migra
DEN180059 · QGT
Theranica Bioelectronics , Ltd.
Neurology · 195d
Not Cleared Apr 24, 2019
Comaneci, Comaneci Petit, Comaneci 17
DEN170064 · PUU
Rapid Medical , Ltd.
Neurology · 573d
Not Cleared Apr 19, 2019
PREVENA 125 and PREVENA PLUS 125 Therapy Units
DEN180013 · QFC
Kci USA, Inc.
General & Plastic Surgery · 400d
Not Cleared Apr 19, 2019
Monarch eTNS System
DEN180041 · QGL
Neurosigma, Inc.
Neurology · 263d
Not Cleared Apr 12, 2019
Plenity
DEN180060 · QFQ
Gelesis, Inc.
Gastroenterology & Urology · 148d