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
7369–7392 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 16, 2024
Co2 Laser System, Models: PureLase And VanLase
K232133 · GEX
Cpmt Laser (Canadian Pioneer Medical...
General & Plastic Surgery · 273d
Cleared Apr 15, 2024
Glide (91000-GL-X)
K240884 · GXY
Infinite Biomedical Technologies, LLC
Neurology · 14d
Cleared Apr 15, 2024
VisAble.IO
K240773 · QTZ
Techsomed
Radiology · 25d
Cleared Apr 15, 2024
Ez Catch Auto
K240205 · GCJ
Veol Medical Technologies Pvt , Ltd.
General & Plastic Surgery · 81d
Cleared Apr 15, 2024
Folysil Silicone Catheter
K233411 · EZL
Coloplast Corp.
Gastroenterology & Urology · 192d
Cleared Apr 15, 2024
Novalung ultimate kit (US)
K232926 · QJZ
Fresenius Medical Care Renal...
Cardiovascular · 208d
Cleared Apr 15, 2024
Access Ostase
K232904 · CIN
Beckman Coulter
Chemistry · 210d
Cleared Apr 15, 2024
Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM...
K223113 · NHA
Medentika GmbH
Dental · 560d
Cleared Apr 14, 2024
XN Knee Prosthesis System
K232175 · JWH
Beijing Chunlizhengda Medical...
Orthopedic · 268d
Cleared Apr 12, 2024
Fine Osteotomy™
K240703 · HRS
Bodycad Laboratories, Inc.
Orthopedic · 29d
Cleared Apr 12, 2024
Healgen Accurate Urine Drug Screen Dip Card
K240686 · NGL
Healgen Scientific, LLC
Toxicology · 31d
Cleared Apr 12, 2024
OASIS MRI System
K240571 · LNH
Fujifilm Healthcare Corporation
Radiology · 43d
Cleared Apr 12, 2024
Ceramic Femoral Head
K240452 · LZO
Microport Orthopedics, Inc.
Orthopedic · 57d
Cleared Apr 12, 2024
UltraThineer Zirconia Slurry (5Y-B)
K240419 · EIH
Boston Micro Fabrication
Dental · 59d
Cleared Apr 12, 2024
Stryker Orthopaedics Hip Systems Labeling Update
K240418 · JDI
Howmedica Osteonics Corp., Dba...
Orthopedic · 59d
Cleared Apr 12, 2024
Vantage Fortian/Orian 1.5T, MRT-1550, V9.0 with AiCE Reconstruction...
K240238 · LNH
Canon Medical Systems Corporation
Radiology · 74d
Cleared Apr 12, 2024
Medical electronic thermometer (FC01, FC02)
K240109 · FLL
Zhuzhou Goldenhot Medical Technology...
General Hospital · 87d
Cleared Apr 12, 2024
HCG One Step Pregnancy Test Strip OTC, HCG One Step Pregnancy Test Strip Rx,...
K233624 · LCX
Hangzhou Aichek Medical Technology...
Chemistry · 151d
Cleared Apr 12, 2024
Mobility+ Enteral Feeding System OTC
K233034 · PIF
Rockfield Medical
Gastroenterology & Urology · 200d
Cleared Apr 12, 2024
Duo Hands-free Breast Pump
K232608 · HGX
Medela, LLC
Obstetrics & Gynecology · 228d
Cleared Apr 12, 2024
MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay...
K232587 · MRG
Shenzhen New Industries Biomedical...
Chemistry · 231d
Cleared Apr 12, 2024
VenusX
K232489 · IYE
Linatech, LLC
Radiology · 239d
Cleared Apr 12, 2024
Disposable Injection Needles
K232200 · FBK
Ningbo Xinwell Medical Technology...
Gastroenterology & Urology · 262d
Cleared Apr 12, 2024
Access NT-proBNP
K232164 · NBC
Beckman Coulter, Inc.
Chemistry · 266d