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: Cleared only ×
175,230 results
697–720 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared May 18, 2026
HALYARD* ONE-STEP* Sterilization Wrap
K253454 · FRG
O&M Halyard, Inc.
General Hospital · 227d
Cleared May 18, 2026
Coude Sleeved IC
K253295 · EZD
Hollister Incorporated
Gastroenterology & Urology · 231d
Cleared May 18, 2026
STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices
K252047 · NEW
Ethicon, Inc.
General & Plastic Surgery · 322d
Cleared May 16, 2026
BluEX Cervical Expandable Cage System
K260840 · ODP
L & K Biomed Co., Ltd.
Orthopedic · 61d
Cleared May 15, 2026
UNiD™ Spine Analyzer (SW3002)
K261289 · QIH
Medicrea International S.A.S....
Radiology · 25d
Cleared May 15, 2026
Neurophet AQUA
K261273 · QIH
Neurophet., Inc.
Radiology · 28d
Cleared May 15, 2026
Stellaris Elite™ vision enhancement system
K261264 · HQC
Bausch and Lomb
Ophthalmic · 29d
Cleared May 15, 2026
Varion Thoracolumbar Fixation System
K260989 · NKB
Kyocera Medical Technologies Inc. (KMTI)
Orthopedic · 51d