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
121–144 of 490
Search insights Median review: 299d Top manufacturer: Centers For Disease Control and Prevention Lead specialty: Microbiology
Not Cleared Aug 03, 2023
Viz HCM
DEN230003 · QXO
Viz. Ai, Inc.
Cardiovascular · 205d
Not Cleared Jul 19, 2023
Galen ES Cooperative Surgical Assistant Platform, Galen ES
DEN220047 · QXG
Galen Robotics
Ear, Nose, Throat · 362d
Not Cleared Jul 14, 2023
Ruthless Spine RJB
DEN230012 · QWL
Ruthless, LLC Dba Ruthless Spine
Orthopedic · 148d
Not Cleared Jul 07, 2023
BT-001
DEN220058 · QXC
Better Therapeutics
Chemistry · 289d
Not Cleared Jun 29, 2023
KidneyIntelX.dkd
DEN200052 · QWZ
Renalytix Ai, Inc.
Chemistry · 1037d
Not Cleared Jun 16, 2023
Neoasis
DEN220048 · QWX
Invictus Medical, Inc.
General Hospital · 326d
Not Cleared Jun 09, 2023
Eroxon
DEN220078 · QWW
Futura Medical Developments Limited
Gastroenterology & Urology · 231d
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