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
529–552 of 1,922
Search insights Median review: 132d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Jun 04, 2026
Signature™ ONE System
K261510 · QHE
Orthosoft Inc. (d/b/a) Zimmer CAS
Orthopedic · 28d
Cleared Jun 04, 2026
Spectra Platinum Mini
K260956 · HGX
Uzinmedicare Co., Ltd.
Obstetrics & Gynecology · 73d
Cleared Jun 04, 2026
LIAISON Murex HBsAg Qual
K260770 · LOM
DiaSorin, Inc.
Microbiology · 87d
Cleared Jun 04, 2026
LumiGlam Laser System (SHE-LSP601-3)
K260690 · GEX
Beijing Sano Laser S&T Development...
General & Plastic Surgery · 93d
Cleared Jun 04, 2026
Dental Cone Beam Computed Tomography System
K260662 · OAS
Yofo Medical Technology Co., Ltd.
Radiology · 94d
Cleared Jun 04, 2026
DEEPVESSEL Plaque
K260497 · QIH
Keya Medical Technology Co., Ltd.
Radiology · 111d
Cleared Jun 04, 2026
Radius VSM and Accessories
K254209 · MHX
Masimo Corporation
Cardiovascular · 157d
Cleared Jun 04, 2026
TroKit Laparoscope Lens Wiper
K253994 · GCJ
TroCare, LLC
General & Plastic Surgery · 174d
Cleared Jun 04, 2026
Instrument Exit Point on Touch Surgery™ Aide
K253984 · SFE
Covidien, LLC
General & Plastic Surgery · 174d
Cleared Jun 04, 2026
Harmony Referral System with Harmony OCT Viewer (Octave)
K253893 · NFJ
Topcon Healthcare Solutions EMEA Oy
Ophthalmic · 182d
Cleared Jun 04, 2026
Precision S 4K Sinuscope
K253602 · GWG
Stryker Endoscopy
Neurology · 198d
Cleared Jun 04, 2026
Orion
K253553 · BZD
ResMed Corp
Anesthesiology · 202d
Cleared Jun 04, 2026
GT Metabolic MagDI System (MAG-01, MAG-02, DS-01)
K253102 · SAH
Gt Metabolic Solutions, Inc.
General & Plastic Surgery · 253d
Cleared Jun 04, 2026
Respiratory Gating for Scanners (2.1)
K253026 · JAK
Varian Medical Systems, Inc.
Radiology · 258d
Cleared Jun 04, 2026
Strauss Surgical Resection Instruments
K253020 · HIH
American Medical Endoscopy, Inc.
Obstetrics & Gynecology · 258d
Cleared Jun 04, 2026
LUNA 3D
K253004 · IYE
Lap GmbH Laser Applikationen
Radiology · 258d
Cleared Jun 04, 2026
Tuff Cuff™ Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L)
K252575 · FYA
New York Embroidery Studio (NYES)
General Hospital · 294d
Cleared Jun 03, 2026
BracePaste Prime Plus
K261840 · DYH
American Orthodontics
Dental · 1d
Cleared Jun 03, 2026
VSP System (Titanium Palatal Splint)
K261826 · DZJ
3D Systems, Inc.
Dental · 2d
Cleared Jun 03, 2026
iiSure Infusion Set
K261530 · FPA
Deka Research and Development
Chemistry · 26d
Cleared Jun 03, 2026
BioWave BioWraps
K261522 · GXY
Biowave Corporation
Neurology · 27d
Cleared Jun 03, 2026
Tissue Approximation System
K261484 · GAR
Tas Medical, Inc.
General & Plastic Surgery · 29d
Cleared Jun 03, 2026
Permatage Flowable, Settable Hemostatic Bone Paste
K261439 · MTJ
Orthocon, Inc.
Orthopedic · 34d
Cleared Jun 03, 2026
Nitrile Disposable Examination Gloves
K260806 · LZA
Vista Industries,, LLC
General Hospital · 83d