FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
3457–3480 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 03, 2025
Onera STS 2 (ONERA STS 2)
K243220 · MNR
Onera B.V.
Neurology · 269d
Cleared Jul 03, 2025
BD Vacutainer® Eclipse™ Blood Collection Needle
K243207 · JKA
Becton, Dickinson and Company
General Hospital · 275d
Cleared Jul 03, 2025
IPL Treatment Device (MDSQMC-01)
K243123 · ONF
Medusa (Guangxi)Medical Devices Co.,...
General & Plastic Surgery · 276d
Cleared Jul 02, 2025
Pure Impact
K251746 · NGX
Sofwave Medical, Ltd.
Neurology · 26d
Cleared Jul 02, 2025
OsteoFlo HydroFiber
K251720 · MQV
SurGenTec, LLC
Orthopedic · 28d
Cleared Jul 02, 2025
8 mm Assist Cannula
K251490 · GCJ
Intuitive Surgical, Inc.
General & Plastic Surgery · 49d
Cleared Jul 02, 2025
Electric Wheelchair (HG-630)
K251285 · ITI
Zhejiang Automwheel Tech Co., Ltd.
Physical Medicine · 68d
Cleared Jul 02, 2025
EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones)
K251241 · JWH
Encore Medical, L.P.
Orthopedic · 71d
Cleared Jul 02, 2025
SurgiLight 1470 Diode Laser System (Model:Halo)
K251049 · GEX
Micro-Energy Medical Technology Co.,...
General & Plastic Surgery · 90d
Cleared Jul 02, 2025
Fiber Laser Treatment Systems (HS-232,HS-233)
K251031 · ONG
Shanghai Apolo Medical Technology...
General & Plastic Surgery · 90d
Cleared Jul 02, 2025
Identity Shoulder System
K250848 · MBF
Zimmer, Inc.
Orthopedic · 104d
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