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
697–720 of 1,922
Search insights Median review: 132d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared May 20, 2026
Numen™ Helia Coil Embolization System
K260351 · HCG
MicroPort NeuroTech (Shanghai) Co., Ltd.
Neurology · 106d
Cleared May 20, 2026
WAVE PTA Balloon Catheter
K260304 · LIT
WAVE Medical AG
Cardiovascular · 110d
Cleared May 20, 2026
ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM...
K260098 · MHX
Shenzhen Mindray Bio-Medical...
Cardiovascular · 127d
Cleared May 20, 2026
Derma-2
K253911 · LHQ
Neko Health AB
Radiology · 163d
Cleared May 20, 2026
Elos Accurate® Denture Fixation System
K253774 · NHA
Elos Medtech Pinol A/S
Dental · 175d
Cleared May 20, 2026
Aquilion ONE (TSX-308A/TSX-306A) V2.0
K253596 · JAK
Canon Medical Systems Corporation
Radiology · 183d
Cleared May 20, 2026
Blood Pressure Monitor (W06LT)
K253570 · DXN
Shenzhen Jamr Technology Co., Ltd.
Cardiovascular · 184d
Cleared May 20, 2026
LAGIS Endoscopic Instruments- Scissors (EI-330S EI-330S-T EI-330MS EI-330MS-T)
K253134 · GEI
Lagis Enterprise Co., Ltd.
General & Plastic Surgery · 237d
Cleared May 20, 2026
MAASTRO Rectal Applicator Set
K252717 · JAQ
Varian Medical Systems
Radiology · 265d
Cleared May 20, 2026
Zenith Aspiration Catheter
K252707 · NRY
Suzhou Zenith Vascular SciTech Limited
Neurology · 266d
Cleared May 19, 2026
Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses
K261299 · LPL
Pegavision Corporation
Ophthalmic · 29d
Cleared May 19, 2026
DIAFIL Bulk FLOW (Economic Package)
K261071 · EBF
DiaDent Group International
Dental · 48d
Cleared May 19, 2026
FilmArray TF Control Panel M527
K260577 · PMN
Maine Molecular Quality Controls, Inc.
Microbiology · 88d
Cleared May 19, 2026
OrthoEasy Pal
K260268 · OAT
Bernhard Förster GmbH (Bernhard...
Dental · 111d
Cleared May 19, 2026
FITBONE® TRANSPORT AND LENGTHENING SYSTEM
K260146 · HSB
Orthofix Srl
Orthopedic · 119d
Cleared May 19, 2026
MR5 Activ Pro
K254024 · NHN
Multi Radiance Medical, Inc.
Physical Medicine · 154d
Cleared May 19, 2026
LIAISON PLEX Gastrointestinal Flex Assay
K253722 · PCH
Luminex Corporation
Microbiology · 176d
Cleared May 19, 2026
SOGA Lasers therapy system family of Aurora handpiece (Aurora-S)
K253309 · NVK
Shenzhen Soga Technology Co., Ltd.
Dental · 232d
Cleared May 19, 2026
Laport
K252985 · GCJ
Sejong Medical Co., Ltd.
General & Plastic Surgery · 243d
Cleared May 19, 2026
Taperloc® Complete Hip Stem
K251270 · LPH
Biomet, Inc.
Orthopedic · 390d
Cleared May 18, 2026
RhinAer+ Stylus
K260522 · GEI
Aerin Medical, Inc.
Ear, Nose, Throat · 90d
Cleared May 18, 2026
MOSES Raydar™
K260100 · GEX
Boston Scientific Corporation
Gastroenterology & Urology · 125d
Cleared May 18, 2026
G-CEM UNIVERSAL
K254109 · EMA
GC America, Inc.
Dental · 150d
Cleared May 18, 2026
CMN Capillary Function with Virtual Expert for MRI, CT and CBCT
K253831 · LLZ
Cercare Medical A/S
Radiology · 168d