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
2761–2784 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 22, 2025
One-Fil Putty Injectable
K251884 · KIF
Mediclus Co., Ltd.
Dental · 63d
Cleared Aug 22, 2025
CEREGLIDE 71 Catheter System
K251828 · NRY
Cerenovus, Inc.
Neurology · 70d
Cleared Aug 22, 2025
CareSuperb COVID-19/Flu A&B Antigen Combo Home Test
K251604 · SCA
Access Bio, Inc.
Microbiology · 87d
Cleared Aug 22, 2025
PROMO
K251443 · IZL
DRGEM Corporation
Radiology · 105d
Cleared Aug 22, 2025
CoraForce Microcatheter, CoraFlex Microcatheter
K251277 · DQY
Reflow Medical, Inc.
Cardiovascular · 120d
Cleared Aug 22, 2025
Diagnostic Ultrasound System (MX7)
K251192 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 127d
Cleared Aug 22, 2025
CPS Locator 3D Delivery Catheter
K250147 · DQY
Centerpoint Systems
Cardiovascular · 213d
Cleared Aug 22, 2025
EnDrive (EnDriveUS)
K243692 · EKX
Advanced Technology Research (A.T.R.)...
Dental · 266d
Cleared Aug 22, 2025
MammoScreen BD
K243685 · QIH
Therapixel
Radiology · 266d
Cleared Aug 22, 2025
Monoject™ 1mL Tuberculin Syringe Luer-Lock Tip (1180100777)
K243660 · FMF
Cardinalhealth
General Hospital · 268d
Cleared Aug 21, 2025
The Acumed Wrist Fixation System - 2.4mm Screws
K252356 · HRS
Acumed, LLC
Orthopedic · 23d
Cleared Aug 21, 2025
Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use...
K252244 · LZA
Ever Global (Vietnam) Enterprise...
General Hospital · 34d
Cleared Aug 21, 2025
MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS...
K251647 · DZE
Dentsply Sirona, Inc.
Dental · 84d
Cleared Aug 21, 2025
LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910)
K251588 · OHS
Shenzhen Fittop Health Technology...
General & Plastic Surgery · 90d
Cleared Aug 21, 2025
VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)
K251579 · LON
bioMerieux, Inc.
Microbiology · 90d
Cleared Aug 21, 2025
Treace Medical Concepts (TMC) Implant Fixation System
K251135 · HRS
Treace Medical Concepts
Orthopedic · 129d
Cleared Aug 21, 2025
Portable Oxygen Concentrator (JM-P50A)
K251130 · CAW
Jiangsu Jumao X-Care Medical...
Anesthesiology · 132d
Cleared Aug 21, 2025
Vista OS, Vista AI Scan, RTHawk
K251029 · LNH
Vista AI, Inc.
Radiology · 141d
Cleared Aug 21, 2025
ClearTip FNA and FNB Types
K250994 · FCG
Finemedix Co., Ltd.
Gastroenterology & Urology · 142d
Cleared Aug 21, 2025
Fine Osteotomy™
K250923 · HRS
Bodycad Laboratories, Inc.
Orthopedic · 147d
Cleared Aug 21, 2025
Transcutaneous Electrical Nerve Stimulator ( K6133/ K6134/ K6135/ K6136/...
K250784 · NUH
Shenzhen Yicai Health Technology Co.,...
Neurology · 160d
Cleared Aug 21, 2025
Origin™
K243965 · SFO
Nerv Technology Inc. (D.B.A.) Fluidai...
Chemistry · 241d
Cleared Aug 21, 2025
InSee
K241152 · BWF
Tidal Medical Technologies, LLC
Anesthesiology · 482d
Cleared Aug 20, 2025
T1D1
K252104 · NDC
Comerge AG
Chemistry · 48d