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
169–192 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 12, 2026
Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented...
K260102 · PHX
Stryker Corporation (Tornier, Inc.)
Orthopedic · 150d
Cleared Jun 12, 2026
MEDRAD® Imaging Bulk Package Transfer Spike
K253688 · PQH
Bayer Medical Care, Inc.
General Hospital · 203d
Cleared Jun 12, 2026
Spiro-VISTA
K253437 · BTR
Spiro Robotics
Anesthesiology · 254d
Cleared Jun 12, 2026
Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300,...
K253196 · MWI
Midmark Corporation
Cardiovascular · 259d
Cleared Jun 12, 2026
OneStim-DUO Cardiac Stimulator (MP5003-4CO)
K253088 · DQK
Micropace Pty, Ltd.
Cardiovascular · 262d
Cleared Jun 12, 2026
Cognitive Function Neuroimaging (cfNI) Software (1.0.0)
K253015 · OLU
VoxNeuro, Inc.
Neurology · 266d
Cleared Jun 12, 2026
Universal 1417PI
K252996 · MQB
Konica Minolta Healthcare Americas, Inc.
Radiology · 267d
Cleared Jun 12, 2026
ADRx™ Admixture Device
K252987 · LHI
Epic Medical Pte. , Ltd.
General Hospital · 267d
Cleared Jun 12, 2026
BTL-899TT
K252963 · IMJ
BTL Industries, Inc.
Physical Medicine · 268d
Cleared Jun 12, 2026
ThinkQA 3
K252937 · IYE
Dosisoft SA
Radiology · 270d
Cleared Jun 12, 2026
DYNE PORT
K252933 · ODC
Dyne Medical Group, Inc.
Gastroenterology & Urology · 270d
Cleared Jun 12, 2026
Fast PCR Mini Respiratory Panel
K252932 · QOF
Autonomous Medical Devices Incorporated
Microbiology · 270d
Cleared Jun 12, 2026
cobas pulse blood glucose monitoring system
K252323 · PZI
Roche Diagnostics
Chemistry · 322d
Cleared Jun 12, 2026
Barbed PDO Suture
K252171 · NEW
Sutura Medical Technology, Inc.
General & Plastic Surgery · 337d
Cleared Jun 11, 2026
Verge™ Microcatheter
K261610 · KRA
Instylla, Inc.
Cardiovascular · 28d
Cleared Jun 11, 2026
PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant)
K261292 · NUC
PR Personal Care Laboratories
Obstetrics & Gynecology · 52d
Cleared Jun 11, 2026
Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3)
K261256 · LXB
Shenzhen Magnet Technology Co., Ltd.
Ear, Nose, Throat · 56d
Cleared Jun 11, 2026
Snorbliss® Anti-Snoring Device
K261251 · LRK
Endeavor Commerce, LLC
Dental · 56d
Cleared Jun 11, 2026
Ion-L
K261209 · MRW
SurGenTec, LLC
Orthopedic · 59d
Cleared Jun 11, 2026
Rosetta SM, Rosetta SP
K260859 · EIH
Hass Corp.
Dental · 87d
Cleared Jun 11, 2026
ICON 35
K260849 · IOR
Rehasense USA, Inc.
Physical Medicine · 87d
Cleared Jun 11, 2026
FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShield Air,...
K260710 · GCJ
FloShield, Inc.
General & Plastic Surgery · 99d
Cleared Jun 11, 2026
Dexter L6 System
K260653 · SDD
Distalmotion SA
General & Plastic Surgery · 104d
Cleared Jun 11, 2026
Acorn 3D Software (AC-SEG-4009)
K260322 · QIH
Mighty Oak Medical
Radiology · 132d