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
121–144 of 483
Search insights Median review: 299d Top manufacturer: Centers For Disease Control and Prevention Lead specialty: Microbiology
Not Cleared Jun 06, 2023
Cue COVID-19 Molecular Test
DEN220028 · QWB
Cue Health, Inc.
Microbiology · 400d
Not Cleared Jun 02, 2023
Tristel Duo ULT
DEN220041 · QWS
Tristel Solutions Limited
General Hospital · 338d
Not Cleared May 18, 2023
B·R·A·H·M·S sFlt-1/ PlGF KRYPTOR Test System
DEN220027 · QWH
Brahms GmbH, Part of Thermo Fisher...
Chemistry · 381d
Not Cleared May 09, 2023
Stanza
DEN220083 · QWI
Swing Therapeutics, Inc.
Neurology · 169d
Not Cleared May 05, 2023
VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack, VITROS...
DEN210038 · QVP
Ortho-Clinical Diagnostics, Inc.
Microbiology · 592d
Not Cleared May 05, 2023
VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, VITROS...
DEN210040 · QVP
Ortho-Clinical Diagnostics, Inc.
Microbiology · 591d
Not Cleared Apr 20, 2023
Breast Implant Removal Device (BIRD)
DEN220082 · QVS
Gaylord Solutions, LLC
General & Plastic Surgery · 150d
Not Cleared Apr 17, 2023
NTX100 Tonic Motor Activation (NTX100 ToMAc) System
DEN220059 · QWD
Noctrix Health, Inc.
Neurology · 208d
Not Cleared Apr 10, 2023
MISHA Knee System
DEN220033 · QVV
Moximed, Inc.
Orthopedic · 308d
Not Cleared Apr 07, 2023
The N-SWEAT Patch
DEN210055 · QVX
Candesant Biomedical, Inc.
General & Plastic Surgery · 490d
Not Cleared Mar 31, 2023
Masimo SafetyNet
DEN200011 · QVT
Masimo Corporation
Anesthesiology · 1136d
Not Cleared Mar 30, 2023
SNOO Smart Sleeper
DEN210039 · QTG
Happiest Baby, Inc.
General Hospital · 556d
Not Cleared Mar 29, 2023
RemeOs™ Screw LAG Solid
DEN220030 · QJD
Bioretec, Ltd.
Orthopedic · 329d
Not Cleared Mar 08, 2023
Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set
DEN220039 · QVF
Quidel Corporation
Microbiology · 265d
Not Cleared Mar 06, 2023
Lenire Tinnitus Treatment Device
DEN210033 · QVN
Neuromod Devices Limited
Ear, Nose, Throat · 565d
Not Cleared Feb 24, 2023
Caption Interpretation Automated Ejection Fraction Software
DEN220063 · QVD
Caption Health, Inc.
Radiology · 149d
Not Cleared Feb 24, 2023
Pill Sense System
DEN220065 · QUD
Enterasense , Ltd.
Gastroenterology & Urology · 148d
Not Cleared Feb 17, 2023
PMD-200
DEN210022 · QVE
Medasense Biometrics , Ltd.
Anesthesiology · 623d
Not Cleared Feb 03, 2023
Active Anthrax DetectTM Plus Rapid Test
DEN220044 · QUU
InBios International, Inc.
Microbiology · 210d
Not Cleared Feb 01, 2023
RefleXion Medical Radiotherapy System (RMRS)
DEN220014 · QVA
Reflexion Medical, Inc.
Radiology · 343d
Not Cleared Dec 23, 2022
BioXmark
DEN220017 · QUV
Nanovi A/S
Radiology · 294d
Not Cleared Dec 16, 2022
Tornier Pyrocarbon Humeral Head
DEN220012 · QKW
Tornier S.A.S.
Orthopedic · 311d
Not Cleared Nov 09, 2022
Eonis SCID-SMA Kit
DEN200044 · QUE
Perkinelmer, Inc.
Medical Genetics · 854d
Not Cleared Oct 18, 2022
ScanNav Anatomy Peripheral Nerve Block
DEN220024 · QRG
Intelligent Ultrasound Limited
Anesthesiology · 193d