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

Filters: 2026–2026 ×
2,517 results
1705–1728 of 2,517
Search insights Median review: 135d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Apr 07, 2026
Powder Free Synthetic Vinyl Exam Gloves (Blue, Black)
K260860 · LYZ
Basic Medical Technology, Inc.
General Hospital · 22d
Cleared Apr 07, 2026
Multifunctional Operational Dissectors (Electrosurgical Pencils)
K260466 · GEI
Zhejiang shuyou Surgical Instrument...
General & Plastic Surgery · 54d
Cleared Apr 07, 2026
Elecsys Anti-HBc IgM
K260049 · SEI
Roche Diagnostics
Microbiology · 90d
Cleared Apr 07, 2026
Elecsys Anti-HAV IgM
K260048 · LOL
Roche Diagnostics
Microbiology · 90d
Cleared Apr 07, 2026
Elecsys Anti-HBc II
K260046 · SEI
Roche Diagnostics
Microbiology · 90d
Cleared Apr 07, 2026
IWD-Gel™
K254191 · FRO
InnovaCorium, Inc.
General & Plastic Surgery · 105d
Cleared Apr 07, 2026
Power Wheelchair (OS-R-M01S)
K253952 · ITI
Beijing OrionStar Technology Co., Ltd.
Physical Medicine · 118d
Cleared Apr 07, 2026
Momcozy Wearable Breast Pump (S9 Pro, S9 Pro-A, S9 Pro-B, S9 Pro-C, S9 Pro-D,...
K253946 · HGX
Shenzhen Root Innovation Technology...
Obstetrics & Gynecology · 118d
Cleared Apr 07, 2026
PrimeSight UltraView System
K253905 · FAJ
Cogentix Medical, Inc.
Gastroenterology & Urology · 123d
Cleared Apr 07, 2026
ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040)
K253801 · SHP
Anumana, Inc.
Cardiovascular · 130d
Cleared Apr 07, 2026
Voyager DSLT (430840610)
K252979 · HQF
Belkin Vision, Ltd.
Ophthalmic · 202d
Cleared Apr 07, 2026
Warming System
K252861 · DWJ
Hangzhou Tappa Medical Technology...
Cardiovascular · 210d
Cleared Apr 07, 2026
Firefighter™ Pro PTCA Balloon Catheter
K252116 · LOX
Shanghai MicroPort Medical (Group)...
Cardiovascular · 274d
Cleared Apr 06, 2026
ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050,...
K260521 · FED
Zhuhai Pusen Medical Technology Co.,...
Gastroenterology & Urology · 48d
Cleared Apr 06, 2026
VANES Delivery System (VDS)
K260459 · DYB
Zoll Respicardia, Inc.
Cardiovascular · 54d
Cleared Apr 06, 2026
SYNERJET PRO (SP-1002)
K260397 · GEI
Hironic Co., Ltd.
General & Plastic Surgery · 59d
Cleared Apr 06, 2026
GLOSSY COAT (15ML)
K254091 · EBD
YAMAHACHI DENTAL MFG., Co.
Dental · 108d
Cleared Apr 06, 2026
AETOS Shoulder System - CONCELOC Glenoids
K254084 · KWS
Smith & Nephew, Inc.
Orthopedic · 109d
Cleared Apr 06, 2026
APERTO Lucent MRI System
K253862 · LNH
Fujifilm Corporation
Radiology · 124d
Cleared Apr 06, 2026
6450 Ultrasound System (MyLabE80)
K253288 · IYN
Esaote, S.P.A.
Radiology · 189d
Cleared Apr 06, 2026
Light-curing Coloring Materials (ALCM)
K253036 · EBF
Aidite (Qinhuangdao) Technology Co.,...
Dental · 196d
Cleared Apr 06, 2026
Ricoh 3D for Healthcare Bolus
K253025 · IXI
Ricoh 3D For Healthcare, LLC
Radiology · 199d
Cleared Apr 06, 2026
in2 Smart (in2S)
K252809 · QRC
Virility Medical , Ltd.
Gastroenterology & Urology · 215d
Cleared Apr 06, 2026
ProSomnus RPMO2 OSA Device (RPMO2 OSA)
K252765 · PLC
Prosomnus Sleep Technologies
Dental · 220d