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
865–888 of 1,922
Search insights Median review: 132d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared May 01, 2026
Tutamen Self Adhesive Electrodes
K252439 · GXY
Dongguan Tutamen Metalwork Co., Ltd.
Neurology · 270d
Cleared May 01, 2026
VOCO Profluorid Varnish + BioMin
K252073 · LBH
Voco GmbH
Dental · 303d
Not Cleared May 01, 2026
Prolystica Pass Thru Disinfectant Wipes
DEN240075 · SHM
Steris
General Hospital · 505d
Cleared Apr 30, 2026
UltraEZ
K261404 · LBH
Ultradent Products, Inc.
Dental · 1d
Cleared Apr 30, 2026
BEE PLIF Cage
K261067 · MAX
NGMedical GmbH
Orthopedic · 29d
Cleared Apr 30, 2026
AllTest Strep A Rapid Test
K260342 · GTY
Hangzhou AllTest Biotech Co., Ltd.
Microbiology · 87d
Cleared Apr 30, 2026
OrthoPediatrics® Locking Cannulated Blade Plate System
K260323 · HRS
OrthoPediatrics Corp.
Orthopedic · 90d
Cleared Apr 30, 2026
Synapse 3D Base Tools (V7.2)
K254189 · QIH
Fujifilm Corporation
Radiology · 128d
Cleared Apr 30, 2026
iLet ACE Pump
K253976 · QFG
Beta Bionics, Inc.
Chemistry · 139d
Cleared Apr 30, 2026
c-med0 alpha
K253436 · MWI
Cosinuss GmbH
Cardiovascular · 211d
Cleared Apr 30, 2026
Air Pressure Therapy System (VU-IPC8M)
K253064 · IRP
Xiamen Weiyou Intelligent Technology...
Physical Medicine · 220d
Cleared Apr 30, 2026
BloodSTOP iX Trauma Matrix (TM-iX-20)
K253017 · QSY
Lifescience Plus, Inc.
General & Plastic Surgery · 223d
Cleared Apr 30, 2026
4K UHD Endoscopy Camera System (KMS-4K-2088, KMS-4K-2188, KMS-4K-2288)
K252858 · GCJ
Kms Medical Technology Co., Ltd.
General & Plastic Surgery · 233d
Cleared Apr 30, 2026
AffloVest® Mobile Airway Clearance Therapy
K252849 · BYI
Tactile Medical
Anesthesiology · 234d
Cleared Apr 30, 2026
Intelligent NR
K252503 · OWB
Canon, Inc.
Radiology · 265d
Cleared Apr 30, 2026
FSYX Ocular Pressure Adjusting Pump
K252455 · QQJ
Balance Ophthalmics, Inc.
Ophthalmic · 268d
Cleared Apr 30, 2026
Ambu® Virobac II® Exhalation Filter
K251583 · CAH
Ambu A/S
General Hospital · 342d
Cleared Apr 30, 2026
Bayesian Health Sepsis Flagging Device
K250680 · SAK
Bayesian Health, Inc.
Gastroenterology & Urology · 420d
Not Cleared Apr 30, 2026
Aurie System
DEN250023 · SHV
Cathbuddy, Inc.
Gastroenterology & Urology · 328d
Cleared Apr 29, 2026
YellowStar
K261094 · GEX
Asclepion Laser Technologies GmbH
General & Plastic Surgery · 27d
Cleared Apr 29, 2026
Break Wave
K261086 · LNS
Sonomotion, Inc.
Gastroenterology & Urology · 28d
Cleared Apr 29, 2026
Echo Large Bore Introducer Sheath
K260606 · DYB
Echo Medical, LLC
Cardiovascular · 64d
Cleared Apr 29, 2026
ES-Series
K260589 · IYN
E-Scopics
Radiology · 68d
Cleared Apr 29, 2026
syngo Application Software
K254184 · QIH
Siemens Medical Solutions USA, Inc.
Radiology · 127d