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
4057–4080 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 03, 2025
stay•safe® catheter extension set with Safe- Lock, 12 inch
K250404 · KDJ
Fresenius Medical Care Renal...
Gastroenterology & Urology · 50d
Cleared Apr 03, 2025
StaClear Syringe (SC250AN)
K243936 · QLY
Staclear, Inc.
General Hospital · 104d
Cleared Apr 03, 2025
OSSIOfiber® Suture Anchor 2.5-3.5 mm
K243760 · MAI
OSSIO , Ltd.
Orthopedic · 118d
Cleared Apr 03, 2025
Salvo® Robotic Navigation Instruments
K243514 · OLO
Spine Wave, Inc.
Orthopedic · 141d
Cleared Apr 03, 2025
Masimo W1
K243305 · DPS
Masimo Corporation
Cardiovascular · 164d
Cleared Apr 03, 2025
Venus Ultimate-Dual, Venus Ultimate-Hepa, Venus Ultimate-Uro Diagnostic...
K243298 · IYN
Carbon (Shenzhen) Medical Device Co.,...
Radiology · 167d
Cleared Apr 03, 2025
syngo Dynamics (Version VA41D)
K242551 · QIH
Siemens Healthcare GmbH
Radiology · 219d
Cleared Apr 03, 2025
Powered wheelchair (mobility robot) (M4, M4U)
K242358 · ITI
Xsto Co., Ltd.
Physical Medicine · 238d
Cleared Apr 03, 2025
Leos Laser and Endoscopy System
K240615 · HQF
Beaver-Visitec International, Inc.
Ophthalmic · 394d
Cleared Apr 02, 2025
twiist system
K250930 · QFG
Deka Research & Development Corp.
Chemistry · 5d
Cleared Apr 02, 2025
SPECTRUM GV Bone Cement
K250760 · LOD
Osteoremedies, LLC
Orthopedic · 20d
Cleared Apr 02, 2025
Sonata Transcervical Fibroid Ablation System 2.2
K250705 · KNF
Gynesonics, Inc.
Obstetrics & Gynecology · 23d
Cleared Apr 02, 2025
LEGION Total Knee System
K250677 · JWH
Smith & Nephew, Inc.
Orthopedic · 27d
Cleared Apr 02, 2025
SnapHammer Hammertoe Correction System
K250613 · HWC
Nvision Biomedical Technologies, Inc.
Orthopedic · 33d
Cleared Apr 02, 2025
eufy Wearable Breast Pump S1 (T8D02) Model T8D02
K250152 · HGX
Shenzhen TPH Technology Co., Ltd.
Obstetrics & Gynecology · 71d
Cleared Apr 02, 2025
Small Volume 0.2mL Syringe
K250138 · QNQ
Prosum Medical Limited
General Hospital · 75d
Cleared Apr 02, 2025
Remplir (ON-152, 15 x 20 mm)
K243889 · JXI
Orthocell, Ltd.
Neurology · 105d
Cleared Apr 02, 2025
SION blue PLUS
K243733 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 119d
Cleared Apr 02, 2025
FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion Instruments
K243659 · OLO
SeaSpine Orthopedics Corporation
Orthopedic · 126d
Cleared Apr 02, 2025
Progenix Select Stim
K242460 · NUH
Progenix, LLC
Neurology · 226d
Cleared Apr 02, 2025
LifeShield Infusion Safety Software Suite
K242117 · PHC
Icu Medical, Inc.
General Hospital · 257d
Cleared Apr 02, 2025
Plum Duo™ Precision IV Pump
K242115 · FRN
Icu Medical, Inc.
General Hospital · 257d
Cleared Apr 02, 2025
Plum Solo™ Precision IV Pump
K242114 · FRN
Icu Medical, Inc.
General Hospital · 257d
Cleared Apr 02, 2025
Nerve Wrap (07-DW-001-TAB)
K242113 · JXI
Biocircuit Technologies, Inc.
Neurology · 257d