FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
385–408 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 27, 2026
Scarlet Pro (Scarlet Pro)
K253859 · GEI
VIOL Co., Ltd.
General & Plastic Surgery · 267d
Cleared Aug 26, 2026
VariLift-C Cervical Interbody Fusion System
K262595 · ODP
Wenzel Spine, Inc.
Orthopedic · 30d
Cleared Aug 26, 2026
GraftGun Universal Graft Delivery System (GDS®)
K262581 · FMF
SurGenTec, LLC
Orthopedic · 30d
Cleared Aug 26, 2026
Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus,...
K261394 · DXN
Joytech Healthcare Co. , Ltd.
Cardiovascular · 119d
Cleared Aug 26, 2026
LithoVue Elite Digital Flexible Ureteroscope System
K261153 · FGB
Boston Scientific Corporation
Gastroenterology & Urology · 140d
Cleared Aug 26, 2026
Ponto 5 Mini
K261142 · MAH
Oticon Medical AB
Ear, Nose, Throat · 141d
Cleared Aug 26, 2026
OEV-271MUH LCD Monitor
K260972 · GCJ
Sony Corporation
General & Plastic Surgery · 155d
Cleared Aug 26, 2026
Heartvue.Proton
K260811 · QIH
Heartvue.ai, Inc.
Radiology · 167d
Cleared Aug 26, 2026
MRIA Radiation Therapy Information System (MRIA)
K260733 · IYE
Manteia Technologies Co., Ltd.
Radiology · 173d
Cleared Aug 26, 2026
Principle & Will ANSI/AAMI PB 70 (Sterile/Non-sterile) Level 3 Surgical Gowns...
K260407 · FYA
Principle & Will Co., Ltd.
General Hospital · 198d
Cleared Aug 26, 2026
HOPKINS Telescopes for Arthroscopy
K254103 · HRX
Karl Storz SE & CO. KG
Orthopedic · 250d
Cleared Aug 26, 2026
StimTrial Neuromodulation System
K253877 · GZF
Bioventus, LLC
Neurology · 265d
Cleared Aug 26, 2026
Edi Catheter ENFit 6Fr/48 cm (6893166)
K253715 · PIF
Maquet Critical Care AB
Gastroenterology & Urology · 275d
Cleared Aug 25, 2026
Disposable blood lancet (Soft Pro, Softsure, Softsure Pro, Softsense)
K262631 · QRK
SteriLance Medical (Suzhou), Inc.
General & Plastic Surgery · 27d
Cleared Aug 25, 2026
Report Studio
K261747 · OLV
Beacon Biosignals, Inc.
Neurology · 90d
Cleared Aug 25, 2026
Promisemed X-Safety Pen Needle
K261719 · FMI
Promisemed Hangzhou Meditech Co., Ltd.
General Hospital · 91d
Cleared Aug 25, 2026
Ceevra Reveal 4
K261595 · QIH
Ceevra, Inc.
Radiology · 103d
Cleared Aug 25, 2026
Calcium Hydroxide Temporary Filling Material (KP-Cal)
K261514 · KIF
Guilin Kevin Peter Technology Co., Ltd.
Dental · 110d
Cleared Aug 25, 2026
iNOS intraoral biosensor
K254304 · PLC
Achaemenid, LLC
Dental · 237d
Cleared Aug 25, 2026
MONOFIX PDO
K253879 · NEW
Samyang Holdings Corporation
General & Plastic Surgery · 264d
Cleared Aug 25, 2026
Inno-Switch™ Laparoscopic Instruments
K252535 · GEI
Taiwan Surgical Corporation
General & Plastic Surgery · 378d
Cleared Aug 25, 2026
SOL-M Luer Lock Syringe with Exchangeable Needle Tray
K252184 · FMF
Sol-Millennium Medical, Inc.
General Hospital · 410d
Cleared Aug 24, 2026
TiLink-L™ SI Joint Fusion System
K261381 · OUR
SurGenTec, LLC
Orthopedic · 119d
Cleared Aug 24, 2026
BiWaze Clear System
K260604 · NHJ
Abmrc, LLC
Anesthesiology · 181d