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
11713–11736 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 07, 2022
Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon...
K223394 · HQD
Visionary Optics, LLC
Ophthalmic · 29d
Cleared Dec 07, 2022
Cios Select (VA21) Flat Panel
K223410 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 28d
Cleared Dec 06, 2022
Femoral Trochanteric Nail System – Neonail
K221021 · HSB
Neoortho Produtos Ortop?dicos S/A
Orthopedic · 244d
Cleared Dec 06, 2022
R2 Studio Q/RCT820
K222219 · OAS
Megagen Implant Co., Ltd.
Radiology · 134d
Cleared Dec 06, 2022
MedDream
K222320 · LLZ
Softneta Uab
Radiology · 126d
Cleared Dec 06, 2022
Bifurcated Needle
K222385 · SCL
Anhui Tiankang Medical Technology...
General Hospital · 120d
Cleared Dec 06, 2022
Bausch + Lomb Preservative Free Lubricating and Rewetting Drops
K222541 · LPN
Bausch & Lomb, Incorporated
Ophthalmic · 106d
Cleared Dec 06, 2022
HurriChem Device Kit
K222575 · GCJ
Thermasolutions, LLC
General & Plastic Surgery · 103d
Cleared Dec 06, 2022
Dental Zirconia Ceramic
K222626 · EIH
Aidite (Qinhuangdao) Technology Co.,...
Dental · 97d
Cleared Dec 06, 2022
iCE-SG2 Subcutaneous Electrode Kit
K222706 · GZL
Ice Neurosystems, Inc.
Neurology · 90d
Cleared Dec 06, 2022
Swoop Portable MR Imaging System
K223247 · LNH
Hyperfine, Inc.
Radiology · 46d
Cleared Dec 06, 2022
Optima Coil System
K223386 · HCG
Balt USA, LLC
Neurology · 29d
Cleared Dec 06, 2022
Cios Select (VA21) Image Intensifier
K223409 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 27d
Cleared Dec 06, 2022
Premier's MultiMatch Universal Chameleon Restorative Composite
K223632 · EBF
Premier Dental Products Company
Dental · 1d
Cleared Dec 05, 2022
BPAP System
K213169 · MNS
BMC Medical Co., Ltd.
Anesthesiology · 433d
Cleared Dec 05, 2022
ClearRead CT
K221612 · OEB
Riverain Technologies, Inc.
Radiology · 185d
Cleared Dec 05, 2022
TruLift Lateral Expandable Spacer System & Lateral Plate System
K221806 · MAX
Life Spine, Inc.
Orthopedic · 166d
Cleared Dec 05, 2022
OK Plus Indicator
K222137 · JOJ
Propper Manufacturing Co., Inc.
General Hospital · 139d
Cleared Dec 05, 2022
Zavation Spinal System
K222614 · NKB
Zavation Medical Products, LLC
Orthopedic · 97d
Cleared Dec 05, 2022
Cryopush Cold Compression Device
K222669 · IRP
Chengdu Cryo-Push Medical Technology...
Physical Medicine · 90d
Cleared Dec 05, 2022
Altaviz Needle Kit
K222681 · FMI
Altaviz, LLC
General Hospital · 90d
Cleared Dec 05, 2022
Mallya Injection Pen Adapter (Mallya® for Solostar®)
K222689 · QOG
Biocorp Production
General Hospital · 90d
Cleared Dec 05, 2022
BriefCase
K222692 · QFM
Aidoc Medical , Ltd.
Radiology · 90d
Cleared Dec 05, 2022
Disposable Medical Face Mask
K223055 · FXX
Xiantao Zhuobo Industrial Co., Ltd.
General Hospital · 67d