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
4537–4560 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 06, 2025
Stryker Orthopaedics Hip Devices Labeling Update
K243784 · LPH
Howmedica Osteonics Corp., Dba...
Orthopedic · 59d
Cleared Feb 06, 2025
VMAT PRO
K243488 · ISA
Termosalud
Physical Medicine · 86d
Cleared Feb 06, 2025
Diode Laser Hair Removal Device (EVOLUTION MEDICAL)
K243465 · GEX
Guangzhou Chuang Zao Mei Technology...
General & Plastic Surgery · 90d
Cleared Feb 06, 2025
Delphi MCS Electrode Cap
K243243 · GXY
Quantalx Neuroscience, Ltd.
Neurology · 118d
Cleared Feb 06, 2025
308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C...
K242977 · FTC
Xuzhou Kernel Medical Equipment Co.,...
General & Plastic Surgery · 133d
Cleared Feb 06, 2025
Unimed Reusable Finger Clip SpO2 Sensors (U103-125)
K242580 · DQA
Unimed Medical Supplies, Inc.
Anesthesiology · 160d
Cleared Feb 06, 2025
Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus,...
K242428 · NGL
Guangzhou Decheng Biotechnology Co.,...
Toxicology · 175d
Cleared Feb 06, 2025
DUTAU-NOVATECH®
K242324 · EOQ
Novatech SA
Ear, Nose, Throat · 184d
Cleared Feb 06, 2025
Disposable Sphincterotome
K242192 · KNS
Beijing Zksk Technology Co., Ltd.
Gastroenterology & Urology · 195d
Cleared Feb 06, 2025
VIVACE
K242111 · HGX
Unimom.Co
Obstetrics & Gynecology · 202d
Cleared Feb 06, 2025
CROSSLEAD 0.014inch
K241702 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 238d
Cleared Feb 06, 2025
Signature Osteosynthesis Plate System
K241599 · HRS
Signature Orthopaedic Pty , Ltd.
Orthopedic · 247d
Cleared Feb 05, 2025
GRYPHON™ X Anchor
K243790 · MAI
Depuy Mitek
Orthopedic · 57d
Cleared Feb 05, 2025
GraftGun Universal Graft Delivery System (GDS)
K243580 · FMF
SurGenTec, LLC
Orthopedic · 78d
Cleared Feb 05, 2025
LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B,...
K243555 · OLP
Shenzhen Eyco Technology Co., Ltd.
General & Plastic Surgery · 79d
Cleared Feb 05, 2025
CROMA Electrosurgical Generator (PRD-EMR-050)
K242983 · GEI
Creo Medical, Ltd.
General & Plastic Surgery · 132d
Cleared Feb 05, 2025
Caliber Intramedullary Fixation System
K242896 · HWC
Nvision Biomedical Technologies
Orthopedic · 135d
Cleared Feb 05, 2025
Accurate Mini Non-invasive blood pressure monitor (AMB-001)
K242352 · DXN
Accurate Meditech, Inc.
Cardiovascular · 181d
Cleared Feb 05, 2025
BoneMetrics (US)
K241593 · QIH
Gleamer Sas
Radiology · 247d
Cleared Feb 05, 2025
TrainFES Advance
K241488 · IPF
Trainfes
Physical Medicine · 257d
Cleared Feb 05, 2025
Navient Image Guide Navigation System (955-NC-NC), Cranial
K241327 · HAW
Claronav
Neurology · 271d
Cleared Feb 04, 2025
Venclose digiRF Generator (VCRFG1)
K250068 · GEI
Venclose, Inc.
General & Plastic Surgery · 25d
Cleared Feb 04, 2025
rTOP
K243333 · LLZ
Roclub GmbH
Radiology · 103d
Cleared Feb 04, 2025
Geon (S2) Nasal Aspirator
K243138 · BTA
Geon Corporation
Ear, Nose, Throat · 127d