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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
3193–3216 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 02, 2025
CS-Pro MED
K250779 · PZL
Curative Sound Therapeutics
General & Plastic Surgery · 110d
Cleared Jul 02, 2025
Power Wheelchair (MOB1107)
K250729 · ITI
Vive Health, LLC
Physical Medicine · 113d
Cleared Jul 02, 2025
OPUSWAVE Dual Sensor Imaging System
K250684 · NQQ
Terumo Cardiovascular Systems Thi Plant
Cardiovascular · 118d
Cleared Jul 02, 2025
Orthoscan TAU Mini C-Arm
K250587 · OXO
Ziehm-Orthoscan, Inc.
Radiology · 125d
Cleared Jul 02, 2025
Mendaera Guidance System
K250524 · ITX
Mendaera, Inc.
Radiology · 131d
Cleared Jul 02, 2025
G0 Blood Pressure Monitoring System (G0)
K250415 · DXN
Aktiia SA
Cardiovascular · 139d
Cleared Jul 02, 2025
Leksell Gamma Knife® (Elekta Esprit)
K250391 · IWB
Elekta Solutions AB
Radiology · 140d
Cleared Jul 02, 2025
Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant
K250312 · BTT
Medline Industries, LP
Anesthesiology · 149d
Cleared Jul 02, 2025
RC-SwiftPrep
K250279 · KJJ
Belport Company, Inc., Gingi-Pak
Dental · 152d
Cleared Jul 02, 2025
Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses
K243868 · LPL
Pegavision Corporation
Ophthalmic · 197d
Cleared Jul 02, 2025
AuroLase® System
K243701 · GEX
Nanospectra Biosciences, Inc.
General & Plastic Surgery · 215d
Cleared Jul 02, 2025
Compressor Nebulizer (NB-1100)
K243468 · CAF
Joytech Healthcare Co. , Ltd.
Anesthesiology · 236d
Cleared Jul 02, 2025
Boehringer Laboratories Liver Retractor
K243399 · GCJ
Boehringer Laboratories, LLC
General & Plastic Surgery · 244d
Cleared Jul 01, 2025
SnugFit ASA Extension
K251933 · MBI
Medacta International S.A.
Orthopedic · 7d
Cleared Jul 01, 2025
Momentum® Posterior Spinal Fixation System
K251719 · NKB
Ulrich Medical USA, Inc.
Orthopedic · 27d
Cleared Jul 01, 2025
Arthrex iBalance Partial Knee System
K251453 · HSX
Arthrex, Inc.
Orthopedic · 50d
Cleared Jul 01, 2025
Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM)
K251212 · LJS
Access Vascular, Inc.
General Hospital · 74d
Cleared Jul 01, 2025
MiniMed 780G insulin pump
K251032 · QFG
Medtronic Minimed, Inc.
Chemistry · 89d
Cleared Jul 01, 2025
Cure Twist Female 8 Catheter (T8)
K250699 · EZD
Convatec
Gastroenterology & Urology · 116d
Cleared Jul 01, 2025
StrokeSENS ASPECTS Software Application
K250221 · POK
Circle Cardiovascular Imaging, Inc.
Radiology · 158d
Cleared Jul 01, 2025
Endoscopic Camera System
K250204 · FET
Shenzhen Sophway Technology Co., Ltd.
General & Plastic Surgery · 158d
Cleared Jul 01, 2025
Felix NeuroAI System
K250096 · QBC
Fasikl Incorporated
Neurology · 168d
Cleared Jul 01, 2025
droplet® personal lancets
K250016 · QRK
Htl-Strefa S.A
General & Plastic Surgery · 179d
Cleared Jul 01, 2025
Bunkerhill Abdominal Aortic Quantification (AAQ)
K243779 · QIH
BunkerHill Health
Radiology · 204d