FDA 510(k) Regulatory Intelligence Search

Search devices, predicates, manufacturers and submission history used by regulatory affairs and medical device strategy teams.

174,883 clearances · 1976 to present · Updated monthly from FDA records

Filters: Not cleared only ×
474 results
193–216 of 474
Search insights Median review: 294d Top manufacturer: Centers For Disease Control and Prevention Lead specialty: Microbiology
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
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