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: 2026–2026 ×
1,642 results
865–888 of 1,642
Search insights Median review: 137d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Apr 03, 2026
Life Saving Tourniquet
K254060 · DXC
TW Medical
Cardiovascular · 107d
Cleared Apr 03, 2026
ClearCheck (RADCC V2.7)
K253962 · IYE
Radformation, Inc.
Radiology · 113d
Cleared Apr 03, 2026
Blueprint Patient-Specific Instrumentation
K253674 · PHX
Stryker Corporation (Tornier, S.A.S.)
Orthopedic · 133d
Cleared Apr 03, 2026
Electric Wheelchair (AL-208S-063)
K253340 · ITI
Zhongshan A&J Medical Equipment Co.,...
Physical Medicine · 185d
Cleared Apr 03, 2026
Disposable Stone Extraction Basket
K253056 · LQR
Zhejiang Soudon Medical Technology...
Gastroenterology & Urology · 193d
Cleared Apr 03, 2026
Tyber Medical Trauma Screw
K253042 · HWC
Tyber Medical, LLC
Orthopedic · 193d
Cleared Apr 03, 2026
Wearable Electric Breast Pump (RH 668, RH 708, RH 718, RH 728)
K252744 · HGX
Cixi Ruihong Electric Appliance Co.,...
Obstetrics & Gynecology · 217d
Cleared Apr 03, 2026
LSSA (NP-200)
K252495 · QPB
Newpong Co., Ltd.
General & Plastic Surgery · 238d
Cleared Apr 03, 2026
Hot and Cold Compression System (A02-C-032)
K252386 · IRP
Chengdu Cryo-Push Medical Technology...
Physical Medicine · 246d
Not Cleared Apr 03, 2026
neuropacs
DEN240071 · SHO
Automated Imaging Diagnostics, LLC
Neurology · 485d
Cleared Apr 02, 2026
Tahoe Unicondylar Knee System with TiNbN Overcoat
K260796 · HSX
Shalby Advanced Technologies, Inc....
Orthopedic · 22d
Cleared Apr 02, 2026
SPECCHIO
K260647 · PBX
El.En S.P.A.
General & Plastic Surgery · 34d
Cleared Apr 02, 2026
Onclarity™ Self-Collection Kit
K260184 · SEP
Becton, Dickinson and Company
Microbiology · 71d
Cleared Apr 02, 2026
Tina-quant Cardiac high sensitivity CRP III
K260026 · NQD
Roche Diagnostics
Chemistry · 87d
Cleared Apr 02, 2026
FLASH Flex™ Aorto-Ostial Angioplasty System
K254022 · LOX
Verge Medical, Inc.
Cardiovascular · 107d
Cleared Apr 02, 2026
Cryopush Cold Compression Device (A02-P-001)
K253076 · IRP
Chengdu Cryo-Push Medical Technology...
Physical Medicine · 191d
Cleared Apr 02, 2026
Wireless Probe Type Ultrasound Scanner
K252709 · IYN
Xuzhou Yongkang Electronic Science...
Radiology · 218d
Cleared Apr 02, 2026
Leforte MMF System
K252246 · JEY
Jeil Medical Corporation
Dental · 258d
Cleared Apr 02, 2026
BELLIGER ACE
K252229 · OWB
Genoray Co., Ltd.
Radiology · 260d
Cleared Apr 02, 2026
Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover)
K252198 · GEH
Medical Brands Laboratories B.V.
General & Plastic Surgery · 262d
Cleared Apr 02, 2026
BD Insyte™ IV Catheter
K252137 · FOZ
Becton Dickinson Infusion Therapy...
General Hospital · 268d
Cleared Apr 02, 2026
LifeShield Infusion Safety Software Suite
K252130 · PHC
Icu Medical, Inc.
General Hospital · 269d
Cleared Apr 02, 2026
Disposable Infusion Bag for Parenteral Nutrition
K252079 · KPE
Beijing L&Z Medical Technology...
General Hospital · 274d
Cleared Apr 02, 2026
SMART M-CELL Bone Marrow Concentration System
K250518 · QBV
Miracell Co., Ltd.
Hematology · 405d