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
2617–2640 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 09, 2025
Bicarby Dialysate RFP-404 (RFP-404-W)
K252180 · KPO
Fresenius Medical Care Renal...
Gastroenterology & Urology · 60d
Cleared Sep 09, 2025
Electric Wheelchair (GY-E001)
K251891 · ITI
Shandong Guyue Healthcare Appliance...
Physical Medicine · 81d
Cleared Sep 09, 2025
Water-soluble Personal Lubricant (Satin Gel Vitamin E flavor lubricant
K251773 · NUC
Shenzhen Yongquan Medical Devices...
Obstetrics & Gynecology · 91d
Cleared Sep 09, 2025
MuscleView 2.0
K251682 · LNH
Springbok, Inc. (Dba Springbok...
Radiology · 102d
Cleared Sep 09, 2025
Segmentron Viewer
K251072 · QIH
DGNCT, LLC
Radiology · 155d
Cleared Sep 09, 2025
MissLan® Early Detection Digital Pregnancy Test
K251040 · LCX
Guangzhou Decheng Biotechnology Co.,...
Chemistry · 159d
Cleared Sep 09, 2025
Edema Guard Monitor (EGM) CardioSet-001
K250922 · DSB
Cardioset Medical , Ltd.
Cardiovascular · 166d
Cleared Sep 09, 2025
PhotonBlade 3
K250483 · GEI
Stryker Instruments
Cardiovascular · 202d
Cleared Sep 09, 2025
Access anti-HAV
K243846 · LOL
Beckman Coulter, Inc.
Microbiology · 267d
Cleared Sep 08, 2025
Coaptium Connect with Tissium Light
K251957 · SFD
Tissium SA
Neurology · 75d
Cleared Sep 08, 2025
BioTraceIO Vision (V1.7)
K251931 · QTZ
Techsomed Medical Technologies
Radiology · 76d
Cleared Sep 08, 2025
MAXXOS P.A.C.E. Foot & Ankle Plating System
K251892 · HRS
Maxxos Medical GmbH
Orthopedic · 80d
Cleared Sep 08, 2025
Wearable Breast Pump (Model S33)
K251754 · HGX
Shenzhen TPH Technology Co., Ltd.
Obstetrics & Gynecology · 91d
Cleared Sep 08, 2025
qER-CTA (v1.0)
K251610 · QAS
Qure.Ai Technologies
Radiology · 104d
Cleared Sep 08, 2025
Momcozy Wearable Breast Pump (BP223)
K251394 · HGX
Shenzhen Root Innovation Technology...
Obstetrics & Gynecology · 126d
Cleared Sep 08, 2025
da Vinci Surgical System (IS5000)
K251227 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 140d
Cleared Sep 08, 2025
DUO Microcatheter
K250960 · QJP
Rev Neuro, LLC
Neurology · 161d
Cleared Sep 08, 2025
OmniTom Elite with PCD
K250928 · JAK
Neurologica Corporation
Radiology · 164d
Cleared Sep 08, 2025
Dual Action Tissue Closure Device
K250229 · PKL
Micro-Tech (Nanjing) Co., Ltd.
Gastroenterology & Urology · 224d
Cleared Sep 05, 2025
Ion Endoluminal System (IF1000)
K252528 · EOQ
Intuitive Surgical, Inc.
Ear, Nose, Throat · 25d
Cleared Sep 05, 2025
Vaccess™ CT Low-Profile Power-Injectable Implantable Port
K252478 · LJT
Bard Access Systems, Inc.
General Hospital · 29d
Cleared Sep 05, 2025
GenaCheck COVID-19 Rapid Self-Test
K251753 · QYT
Genabio Diagnostics, Inc.
Microbiology · 88d
Cleared Sep 05, 2025
SOLOPASS 2.0 System
K251317 · HAW
Intravent Medical Partners
Neurology · 129d
Cleared Sep 05, 2025
ViewMate™ Multi Ultrasound System (VMM-ICE-01)
K251250 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 135d