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
3961–3984 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 15, 2025
Colonovideoscope (CF-EZ1500DL)
K250432 · FDF
Olympus Medical Systems Corporation
Gastroenterology & Urology · 90d
Cleared May 15, 2025
Nitinol Enhanced Device (NED)
K250276 · KRD
Embolization, Inc.
Cardiovascular · 104d
Cleared May 15, 2025
OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit)
K250213 · GXI
Stryker Instruments
Neurology · 111d
Cleared May 15, 2025
Limfa Therapy System (Limfa Therapy)
K243165 · NGX
Eywa Srl
Physical Medicine · 227d
Cleared May 15, 2025
HFT750U
K242931 · MNT
Mekics Co., Ltd.
Anesthesiology · 232d
Cleared May 15, 2025
Lumify Diagnostic Ultrasound System
K242519 · IYN
Philips Ultrasound
Radiology · 265d
Cleared May 15, 2025
Hypertension Prediction Index (HePI) Algorithm
K242518 · QAQ
Edwards Lifesciences, LLC
Cardiovascular · 265d
Cleared May 15, 2025
BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES...
K242479 · KOC
NIKKISO CO., LTD.
Gastroenterology & Urology · 267d
Cleared May 15, 2025
BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES...
K242176 · KOC
NIKKISO CO., LTD.
Gastroenterology & Urology · 295d
Cleared May 15, 2025
DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO)
K242155 · KDI
NIKKISO CO., LTD.
Gastroenterology & Urology · 296d
Cleared May 15, 2025
Youmagic FLM System (YM5-U1)
K240857 · GEI
We Medical Technology (Wuxi) Co., Ltd.
General & Plastic Surgery · 413d
Cleared May 14, 2025
Veincare
K251288 · GEX
Wontech Co., Ltd.
General & Plastic Surgery · 19d
Cleared May 14, 2025
ETHICON 4000 60mm Compact Stapler (EC3D60C)
K250835 · GDW
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 55d
Cleared May 14, 2025
MICROLET®NEXT 2 Lancing Device
K250813 · QRL
Ascensia Diabetes Care U.S., Inc.
General & Plastic Surgery · 58d
Cleared May 14, 2025
Symphony™ Thrombectomy System
K250775 · QEW
Imperative Care, Inc.
Cardiovascular · 61d
Cleared May 14, 2025
Linkt Compression Staple System
K250712 · JDR
Trax Surgical
Orthopedic · 65d
Cleared May 14, 2025
Magnesium alloy scooter (RS100)
K250533 · INI
Taizhou Reach Technology Co., Ltd.
Physical Medicine · 79d
Cleared May 14, 2025
Helios Dura Regeneration Matrix
K250420 · GXQ
Helios Biomedical, Inc.
Neurology · 90d
Cleared May 14, 2025
CaloPix
K250414 · QKQ
Tribun Health
Pathology · 90d
Cleared May 14, 2025
Nerivio
K250405 · QGT
Theranica Bio-Electronics, Ltd.
Neurology · 90d
Cleared May 14, 2025
Medical Picosecond ND: YAG Laser System (PZ-6)
K250041 · GEX
Zhengzhou PZ Laser Slim Technology...
General & Plastic Surgery · 126d
Cleared May 14, 2025
Disposable ureteral stent
K243830 · FAD
Shenzhen Trious Medical Technology...
Gastroenterology & Urology · 152d
Cleared May 14, 2025
Medical Image Post-processing Software (uOmnispace.CT)
K242624 · QIH
Shanghai United Imaging Healthcare...
Radiology · 253d
Cleared May 14, 2025
Smile Dx®
K242437 · MYN
Cube Click, Inc.
Radiology · 271d