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: 2026–2026 ×
1,922 results
457–480 of 1,922
Search insights Median review: 132d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
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
Cleared Jun 11, 2026
PROBEAT-CR
K260174 · LHN
Hitachi High-Tech Corp.
Radiology · 141d
Cleared Jun 11, 2026
Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)
K254145 · NHA
Smart Denture Conversions, LLC
Dental · 171d
Cleared Jun 11, 2026
MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction System
K254087 · KTT
Synthes USA Products, LLC
Orthopedic · 175d
Cleared Jun 11, 2026
Anura Mobile Core SDK (M1)
K253650 · QME
Nuralogix Corporation
Cardiovascular · 203d
Cleared Jun 11, 2026
UNEEG EpiSight System
K253607 · SEM
Uneeg Medical A/S
Neurology · 205d
Cleared Jun 11, 2026
Fluoride Varnish (Type A,Type C)
K253052 · LBH
Nagy Oral Technology Qinhuangdao Co.,...
Dental · 262d
Cleared Jun 11, 2026
i-STAT hs-TnI cartridge with the i-STAT Alinity System
K253051 · MMI
Abbott Point of Care, Inc.
Chemistry · 262d