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
1969–1992 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 21, 2025
LEGACY
K252696 · HBG
Phasor Health, LLC
Neurology · 86d
Cleared Nov 21, 2025
Manual Wheelchair (HM305-Air1, HM305-Air2)
K252687 · IOR
Suzhou Master Machinery Manufacturing...
Physical Medicine · 87d
Cleared Nov 21, 2025
EffortMed PEEK Cages & Corpectomy Cages
K252686 · ODP
Effortmed, LLC
Orthopedic · 87d
Cleared Nov 21, 2025
Articulator Arthroscopic Bur
K252666 · HRX
Joint Preservation Innovations, LLC
Orthopedic · 88d
Cleared Nov 21, 2025
Powered Mobility Scooter (PMS105, GUT177, GCAT047)
K252590 · INI
Intradin (Shanghai) Machinery Co., Ltd.
Physical Medicine · 98d
Cleared Nov 21, 2025
Ceribell Infant Seizure Detection Software
K252070 · OMB
Ceribell, Inc.
Neurology · 143d
Cleared Nov 21, 2025
Archy Dental Imaging
K251880 · LLZ
Archy Dental, Inc.
Radiology · 156d
Cleared Nov 21, 2025
Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4
K251856 · NUH
Everyway Medical Instruments Co.,Ltd
Neurology · 157d
Cleared Nov 21, 2025
StaClear Syringe (SC250AN)
K251849 · QLY
Staclear, Inc.
General Hospital · 158d
Cleared Nov 21, 2025
Oxygen Concentrator (J5A)
K251607 · CAW
Foshan Kycare Medical Equipment Co.,...
Anesthesiology · 178d
Cleared Nov 21, 2025
Nelli (Version 7.11)
K251506 · POS
Neuro Event Labs OY
Neurology · 189d
Cleared Nov 21, 2025
CardioVision
K251293 · QUO
Icardio.Ai
Cardiovascular · 210d
Cleared Nov 21, 2025
Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM Implants
K251205 · NHA
Dentsply Sirona
Dental · 217d
Cleared Nov 21, 2025
FluoroDose Varnish
K250714 · LBH
Centrix, Inc.
Dental · 256d
Cleared Nov 21, 2025
Pen Injector Needle 32.5
K250700 · FMI
Terumo Corporation
General Hospital · 259d
Cleared Nov 21, 2025
Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White...
K250586 · OMP
Deroyal Industries, Inc.
General & Plastic Surgery · 267d
Cleared Nov 21, 2025
BEE HA
K250560 · ODP
NGMedical GmbH
Orthopedic · 269d
Cleared Nov 20, 2025
syngo.MR Applications (VB80)
K253495 · LLZ
Siemens Healthineers AG
Radiology · 23d
Cleared Nov 20, 2025
UltraPrint-Dental Denture UV
K253324 · EBI
Guangzhou Heygears IMC., Inc.
Dental · 51d
Cleared Nov 20, 2025
CORUS-LX Implant
K253190 · MRW
Providence Medical Technology, Inc.
Orthopedic · 55d
Cleared Nov 20, 2025
CuRAS hybrid
K253123 · GEX
Classys, Inc.
General & Plastic Surgery · 56d
Cleared Nov 20, 2025
HardyDisk AST Cefiderocol 30µg (FDC30)
K253105 · JTN
Hardy Diagnostics
Microbiology · 57d
Cleared Nov 20, 2025
Namic Radial Arm Band, 23 cm (DYNJRADBAND)
K253070 · DXC
Medline Industries, LP
Cardiovascular · 58d
Cleared Nov 20, 2025
Laser Fiber (PT-OF-A-S)
K253007 · GEX
Guangzhou Potent Medical Equipment...
General & Plastic Surgery · 62d