FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
6529–6552 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 22, 2024
Kinos Total Ankle System
K241482 · HSN
Restor3d
Orthopedic · 59d
Cleared Jul 22, 2024
K-Bond Universal
K241445 · KLE
Spident Co., Ltd.
Dental · 61d
Cleared Jul 22, 2024
Transcutaneous Electrical Nerve Stimulator (K6106)
K241119 · NUH
Shenzhen Yicai Health Technology Co.,...
Neurology · 90d
Cleared Jul 22, 2024
Onycho Laser V
K241116 · PDZ
Terasysd&C, Inc.
General & Plastic Surgery · 90d
Cleared Jul 22, 2024
ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic...
K240704 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 130d
Cleared Jul 22, 2024
NAVOYCDS
K240558 · PLB
Algodx AB
Cardiovascular · 145d
Cleared Jul 22, 2024
Electric Wheelchair (Robooter E60) (BBR-E60-01)
K240339 · ITI
Shanghai Bangbang Robotics Co., Ltd.
Physical Medicine · 168d
Cleared Jul 22, 2024
Maverick Diagnostic System TC1000
K234091 · JLW
Genalyte, Inc.
Chemistry · 209d
Cleared Jul 22, 2024
neo315
K231133 · LNH
Neoscan Solution GmbH
Radiology · 458d
Cleared Jul 21, 2024
PTG-05
K240347 · NGX
Zimmer Medizinsysteme GmbH
Physical Medicine · 167d
Cleared Jul 19, 2024
coactiv+™ Antimicrobial Wound Gel
K241809 · FRO
Kane Biotech, Inc.
General & Plastic Surgery · 28d
Cleared Jul 19, 2024
Suture Button Repair System
K240835 · MBI
Skeletal Dynamics, Inc.
Orthopedic · 115d
Cleared Jul 19, 2024
Premium Teeth Resin
K240538 · EBG
Formlabs Ohio, Inc.
Dental · 144d
Cleared Jul 19, 2024
IntelliBlate Microwave Ablation System Console (IB-CON)
K240480 · NEY
Varian Medical Systems, Inc.
General & Plastic Surgery · 150d
Cleared Jul 19, 2024
VACUETTE® QUICKSHIELD Complete (Plus)
K233979 · JKA
Greiner Bio-One North America, Inc.
General Hospital · 214d
Cleared Jul 19, 2024
VasoGuard (V10, V8, V6, V4, V2)
K233976 · JOP
Corvascular Diagnostics, LLC
Cardiovascular · 217d
Cleared Jul 19, 2024
Senhance Surgical System
K233866 · NAY
Asensus Surgical, Inc.
General & Plastic Surgery · 226d
Cleared Jul 19, 2024
Wireless TENS & EMS (Model SM9110,SM9113,SM9116)
K233067 · NUH
Chongqing Rob Linka Science and...
Neurology · 297d
Cleared Jul 18, 2024
vRad Viewer
K241879 · LLZ
Virtual Radiologic Corporation
Radiology · 20d
Cleared Jul 18, 2024
Electric Wheelchair (MP201C)
K241463 · ITI
Suzhou Master Machinery Manufacturing...
Physical Medicine · 56d
Cleared Jul 18, 2024
Juliet® Ti LL Lumbar Interbody Device
K241321 · OVD
Spineart SA
Orthopedic · 69d
Cleared Jul 18, 2024
Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay
K241240 · QOF
Hologic, Inc.
Microbiology · 76d
Cleared Jul 18, 2024
Quantum Perfusion Hybrid System
K241206 · DTN
Spectrum Medical S.R.L.
Cardiovascular · 79d
Cleared Jul 18, 2024
HardyDisk AST Cefiderocol 30µg (FDC30)
K241060 · JTN
Hardy Diagnostics
Microbiology · 91d