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
1033–1056 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 16, 2026
Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)
K253447 · GXR
Orthocon, Inc.
Neurology · 165d
Cleared Mar 16, 2026
Stealth AXiS™ ENT clinical application
K253395 · PGW
Medtronic Navigation, Inc.
Ear, Nose, Throat · 167d
Cleared Mar 16, 2026
ZENEX Implant System_Short (R-System)
K253334 · DZE
Izenimplant Co., Ltd.
Dental · 167d
Cleared Mar 16, 2026
Sonio Detect (v3)
K252433 · IYN
Sonio
Radiology · 227d
Cleared Mar 16, 2026
SurgiCount+ System
K252282 · PBZ
Stryker Instruments
Obstetrics & Gynecology · 237d
Cleared Mar 16, 2026
DCwire Micro-guidewire
K252122 · MOF
Shanghai Achieva Medical Suzhou Co.,...
Neurology · 252d
Cleared Mar 15, 2026
Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001)
K253581 · IKT
Technomed Europe
Neurology · 118d
Cleared Mar 13, 2026
Amplatzer™ Trevisio™ Intravascular Delivery System
K260499 · DQY
Abbott Medical
Cardiovascular · 28d
Cleared Mar 13, 2026
TheraSphere 360™ Y-90 Management Platform
K260479 · LLZ
Boston Scientific Corporation
Radiology · 28d
Cleared Mar 13, 2026
New Wave System
K260455 · GWQ
Zeto, Inc.
Neurology · 30d
Cleared Mar 13, 2026
Electric nasal aspirator (BC026, BC025, BC023, BC028, BC029, BC036)
K260147 · BTA
Shenzhen Kingboom Technology Co., Ltd.
Ear, Nose, Throat · 52d
Cleared Mar 13, 2026
Aquilion ServeSP (TSX-307B) V2.0
K260078 · JAK
Canon Medical Systems Corporation
Radiology · 60d
Cleared Mar 13, 2026
Embrace Neonatal MRI System
K254277 · LNH
Aspect Imaging, Ltd.
Radiology · 73d
Cleared Mar 13, 2026
Access anti-HBc IgM
K254059 · SEI
Beckman Coulter, Inc.
Microbiology · 86d
Cleared Mar 13, 2026
BARE Wireguided Balloon Dilation Catheter (1235)
K253987 · FGE
GIE Medical
Gastroenterology & Urology · 91d
Cleared Mar 13, 2026
SafeSept RF Transseptal Guidewire (SSRF132
K253799 · DXF
Pressure Products Medical Device...
Cardiovascular · 105d
Cleared Mar 13, 2026
Permatage Flowable, Settable Bone Paste
K253732 · GXP
Orthocon, Inc.
Neurology · 109d
Cleared Mar 13, 2026
Visualase Cooled Laser Applicator System (9735559)
K253391 · ONO
Medtronic Navigation, Inc.
Neurology · 164d
Cleared Mar 13, 2026
Apollo Quattro (APQ-10M)
K253261 · PBX
Weero Co., Ltd.
General & Plastic Surgery · 165d
Cleared Mar 13, 2026
OptiMap Catheter - 50mm (OPTI-CATH2-50)
K253205 · MTD
Cortex, Inc.
Cardiovascular · 168d
Cleared Mar 13, 2026
Aeka Imaging
K253111 · LLZ
Good Methods Global, Inc.
Radiology · 170d
Cleared Mar 13, 2026
IASIS i2 Relaxation Neurofeedback System
K252923
Iasis Technologies
Neurology · 179d
Cleared Mar 13, 2026
Niti-S SPAXUS Stent
K252648 · PCU
Taewoong Medical Co., Ltd.
Gastroenterology & Urology · 204d
Cleared Mar 13, 2026
Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses
K252385 · LPL
Pegavision Corporation
Ophthalmic · 225d