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
1489–1512 of 2,517
Search insights Median review: 135d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Apr 29, 2026
F6S Full Face Mask (F6S)
K253166 · BZD
BMC Medical Co., Ltd.
Anesthesiology · 215d
Cleared Apr 29, 2026
LEO Spinal System
K252542 · NKB
ZheJiang Decans Medical Devices Co.,...
Orthopedic · 260d
Cleared Apr 29, 2026
Paptizer 360
K252471 · QXQ
LiViliti Health Products Corporation
General Hospital · 266d
Cleared Apr 28, 2026
Automatic Digital Blood Pressure Monitor (LD-587, LD-528, LD-562, LD-581,...
K260260 · DXN
Honsun (Nantong) Co., Ltd.
Cardiovascular · 90d
Cleared Apr 28, 2026
Ultra-Fast Warm
K260248 · MQL
Kitazato Corporation
Obstetrics & Gynecology · 91d
Cleared Apr 28, 2026
Vacuum Pump (Model: AD-VPUM-500)
K260194 · MQG
Sheng Sheng Yi (Beijing) Technology...
Obstetrics & Gynecology · 96d
Cleared Apr 28, 2026
Manual Wheelchair (7101L, 7102LHD)
K260121 · IOR
Foshan Nanhai Hongchen Medical...
Physical Medicine · 103d
Cleared Apr 28, 2026
SAM 3.0 Multi-Hour Continuous Ultrasound Device
K260076 · PFW
ZetrOZ Systems, LLC
Physical Medicine · 106d
Cleared Apr 28, 2026
SAFElife T-Dip Multi-Drug Urine Test Panel
K260065 · NFT
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 109d
Cleared Apr 28, 2026
M.U.S.T. Pedicle Screw System - Extension
K253940 · NKB
Medacta International S.A.
Orthopedic · 140d
Cleared Apr 28, 2026
Cardinal Health™ Poly Reinforced Surgical Gown
K253243 · FYA
Cardinal Health 200, LLC
General Hospital · 211d
Cleared Apr 28, 2026
Pelvic Floor Treatment Device (DLR-8920, DLR-8921, DLR-8922, DLR-8923,...
K252831 · KPI
Dolanvy (Suzhou) Medical Technology...
Gastroenterology & Urology · 235d
Cleared Apr 28, 2026
Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62E3B,...
K252501 · DXN
Joytech Healthcare Co. , Ltd.
Cardiovascular · 263d
Cleared Apr 28, 2026
Surgical Microscope (OMS2360, OMS2380)
K252464 · NBL
Zumax Medical Co., Ltd.
Dental · 265d
Cleared Apr 28, 2026
Anti-HCV Next
K252424 · MZO
Abbott Laboratories
Microbiology · 270d
Cleared Apr 27, 2026
Grandio disc multicolor
K261357 · EBF
Voco GmbH
Dental · 3d
Cleared Apr 27, 2026
Dura-Crown
K261356 · EBF
Hangzhou SHINING3D Dental Technology...
Dental · 3d
Cleared Apr 27, 2026
NovoKnee (SteriKnee)
K261032 · JWH
NovoSource
Orthopedic · 28d
Cleared Apr 27, 2026
SABER-C System
K260660 · OVE
Elevation Spine
Orthopedic · 56d
Cleared Apr 27, 2026
Avenir® Müller Stem
K260182 · LZO
Zimmer, Inc.
Orthopedic · 96d
Cleared Apr 27, 2026
STA Satellite Max®
K253658 · JPA
Diagnostica Stago, Inc.
Hematology · 158d
Cleared Apr 27, 2026
Pelvic Floor Exerciser (PF01)
K252748 · HIR
Hunan Accurate Bio-Medical Technology...
Gastroenterology & Urology · 241d
Cleared Apr 27, 2026
CASSIE
K252628 · MNR
Wesper, Inc.
Anesthesiology · 250d
Cleared Apr 27, 2026
Fusion Bioline Vascular Graft
K252445 · DSY
Maquet Cardiovascular, LLC
Cardiovascular · 266d