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
1849–1872 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 09, 2025
Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and...
K252154 · NGX
Guangzhou Longest Medical Technology...
Physical Medicine · 153d
Cleared Dec 09, 2025
Allia Moveo
K251199 · OWB
GE Medical Systems SCS
Radiology · 235d
Cleared Dec 09, 2025
DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW)
K250805 · CAW
Devilbiss Healthcare, LLC
Anesthesiology · 267d
Cleared Dec 09, 2025
Focused Cryotherapy System
K250742 · GEH
Focused Cryo, Inc.
General & Plastic Surgery · 273d
Cleared Dec 09, 2025
INFINITT DPS
K243449 · QKQ
Infinitt Healthcare Co., Ltd.
Pathology · 397d
Cleared Dec 08, 2025
LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5,...
K252994 · OHS
Guangdong Ace-Tec Co., Ltd.
General & Plastic Surgery · 81d
Cleared Dec 08, 2025
Electric Wheelchair (DH01126)
K252862 · ITI
Foshan Dahao Medical Technology Co.,...
Physical Medicine · 90d
Cleared Dec 08, 2025
Glass Ceramic
K252789 · EIH
Shenzhen Xiangtong Co., Ltd.
Dental · 97d
Cleared Dec 08, 2025
Fetal EchoScan (v1.2)
K252294 · POK
Brightheart
Radiology · 138d
Cleared Dec 08, 2025
Ceribell Delirium Monitor System
K251936 · NCG
Ceribell, Inc.
Neurology · 167d
Cleared Dec 08, 2025
DeGen Medical Patient Specific Implant (PSI) System
K251829 · OVD
Degen Medical
Orthopedic · 178d
Cleared Dec 08, 2025
HeartBeam AIMIGo with 12-L ECG Synthesis Software System
K250258 · DXH
Heartbeam, Inc.
Cardiovascular · 314d
Cleared Dec 08, 2025
Sequential Compression System (SCD600)
K250190 · JOW
Shenzhen Comen Medical Instruments...
Cardiovascular · 319d
Cleared Dec 05, 2025
QuietLab Pro
K253868 · LRK
QuietLab, LLC
Dental · 2d
Cleared Dec 05, 2025
REAL INTELLIGENCE™ CORI™ XT (CORI XT)
K252841 · OLO
Blue Belt Technologies, Inc.
Orthopedic · 88d
Cleared Dec 05, 2025
Manual Wheelchair (W47)
K252828 · IOR
Jiangsu Jumao X-Care Medical...
Physical Medicine · 91d
Cleared Dec 05, 2025
Manual Wheelchair (W45)
K252825 · IOR
Jiangsu Jumao X-Care Medical...
Physical Medicine · 91d
Cleared Dec 05, 2025
mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001)
K252605 · FFX
Medspira, LLC
Gastroenterology & Urology · 109d
Cleared Dec 05, 2025
Gastric Alimetry
K252504 · MYE
Alimetry , Ltd.
Gastroenterology & Urology · 119d
Cleared Dec 05, 2025
Digital Color Doppler Ultrasound System (X11 Exp/X11 Elite/X11 Pro/X11...
K252498 · IYN
Sonoscape Medical Corp.
Radiology · 119d
Cleared Dec 05, 2025
Electrically powered wheelchair (KZ301B)
K252494 · ITI
Nanjing Kangni Smart Technology Co.,...
Physical Medicine · 119d
Cleared Dec 05, 2025
Any-Core
K252465 · EBF
Mediclus Co., Ltd.
Dental · 121d
Cleared Dec 05, 2025
OncoPatch
K252296 · KXK
Oncopatch, Inc.
Radiology · 135d
Cleared Dec 05, 2025
els unibond
K252151 · KLE
Saremco Dental AG
Dental · 149d