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
3025–3048 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 22, 2025
Clear Miracle
K251616 · NXC
Ods Co., Ltd.
Dental · 56d
Cleared Jul 22, 2025
VersaCoat Nerve Protector (VTP-44G2)
K251505 · JXI
Alafair Biosciences
Neurology · 67d
Cleared Jul 22, 2025
OTS 25-L (100-5)
K251310 · MBI
Ots Medical , Ltd.
Orthopedic · 85d
Cleared Jul 22, 2025
Plastic Surgical Kits
K251300 · KCT
Dentsply Sirona, Inc.
General Hospital · 85d
Cleared Jul 22, 2025
LymphaTech Mobile 3D Measuring Tool
K251255 · SFG
Lymphatech, Inc.
General & Plastic Surgery · 90d
Cleared Jul 22, 2025
Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction...
K250901 · LNH
Canon Medical Systems Corporation
Radiology · 118d
Cleared Jul 22, 2025
GyriCalc (Version 1.0.0)
K250686 · LLZ
Neurospectrum Insights Corp.
Radiology · 138d
Cleared Jul 22, 2025
Yushan X-Ray Flat Panel Detector
K250211 · MQB
Innocare Optoelectronics Corp.
Radiology · 179d
Cleared Jul 22, 2025
Disposable Biopsy Needle
K244018 · KNW
Zhejiang Curaway Medical Technology...
General & Plastic Surgery · 207d
Cleared Jul 22, 2025
CardioTag™
K243566 · DXR
Cardiosense, Inc.
Cardiovascular · 246d
Cleared Jul 22, 2025
Vascular Navigation PAD 2.0
K243432 · OWB
Brainlab AG
Radiology · 259d
Cleared Jul 22, 2025
Guided DAS Surgical Kit
K243425 · KCT
Talladium Espa?a, SL
General Hospital · 260d
Cleared Jul 22, 2025
Granudacyn® Wound Irrigation Solution
K243415 · FRO
P.G.F. Industry Solutions GmbH
General & Plastic Surgery · 263d
Cleared Jul 22, 2025
Minnesota Medical Technologies Fecal Incontinence Insert (My Miracle)
K243367 · PBP
Minnesota Medical Technologies
Gastroenterology & Urology · 265d
Cleared Jul 21, 2025
microINR System
K251564 · GJS
Iline Microsystems, S.L.
Hematology · 60d
Cleared Jul 19, 2025
TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System
K250913 · OBJ
Jiangsu Tingsn Technology Co., Ltd.
Cardiovascular · 114d
Cleared Jul 18, 2025
MF SC GEN2 Facial Toning System
K252218 · NFO
Micro Current Technology, Inc.
Neurology · 3d
Cleared Jul 18, 2025
SPY Cystoscope/Hysteroscope
K252012 · HIH
Stryker Endoscopy
Obstetrics & Gynecology · 21d
Cleared Jul 18, 2025
Z1 Hip System
K251906 · LZO
Zimmer, Inc.
Orthopedic · 28d
Cleared Jul 18, 2025
Arthrex FiberTak Suture Anchor
K251809 · MBI
Arthrex, Inc.
Orthopedic · 36d
Cleared Jul 18, 2025
VersaCoat Tendon Protector (VTP-44G2)
K251655 · OWW
Alafair Biosciences
Orthopedic · 49d
Cleared Jul 18, 2025
Profoject™ Enteral Feeding Syringe
K251585 · PNR
CMT Health PTE., Ltd.
Gastroenterology & Urology · 56d
Cleared Jul 18, 2025
InstaFAN
K251542 · ODG
Onepass Medical , Ltd.
Gastroenterology & Urology · 59d
Cleared Jul 18, 2025
V8 Diagnostic Ultrasound System
K250999 · IYN
Samsung Medison Co., Ltd.
Radiology · 108d