FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
6841–6864 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 15, 2024
MVR™ Venous Reservoir Bag 800 mL
K241053 · DTN
Medtronic Cardiac Surgery
Cardiovascular · 28d
Cleared May 15, 2024
CANON Fundus Camera CR-10 (CR-10)
K241049 · HKI
Canon, Inc.
Ophthalmic · 28d
Cleared May 15, 2024
Augment Off-Axis Instrument System
K241043 · PHX
Fix Surgical
Orthopedic · 28d
Cleared May 15, 2024
E3D™-A Interbody System
K240368 · OVD
Evolution Spine
Orthopedic · 99d
Cleared May 15, 2024
Full Wedge Lateralized and Augmented Baseplates
K240278 · PHX
Fx Shoulder USA, Inc.
Orthopedic · 104d
Cleared May 15, 2024
TRIUX™ neo (NM27000N )
K233985 · OLX
Megin OY
Neurology · 149d
Cleared May 15, 2024
Heuron ICH
K233247 · QAS
Heuron Co., Ltd.
Radiology · 230d
Cleared May 15, 2024
BruxZir® NOW SRC
K231940 · NHA
Prismatik Dentalcraft, Inc.
Dental · 320d
Cleared May 14, 2024
Aventus Clot Management System
K240426 · CAC
Inquis Medical
Cardiovascular · 91d
Cleared May 14, 2024
Electric Breast Pump (BRP-301)
K233913 · HGX
Aoj Health Technology Co., Ltd.
Obstetrics & Gynecology · 154d
Cleared May 14, 2024
BNLE Hydrophilic Jacketed Peripheral Guidewire
K232662 · DQX
Biomerics Nle
Cardiovascular · 257d
Cleared May 13, 2024
Healgen® Accurate Fentanyl Rapid Test Cassette (Urine)
K240949 · NGL
Healgen Scientific, LLC
Toxicology · 35d
Cleared May 13, 2024
REMEX-GR100
K240759 · EHD
Remedi Co., Ltd.
Radiology · 54d
Cleared May 13, 2024
1060nm laser body slimming machine
K240658 · PKT
Hebei JT Medical Co., Ltd.
General & Plastic Surgery · 66d
Cleared May 13, 2024
Brainomix 360 e-Lung
K233875 · JAK
Brainomix Limited
Radiology · 158d
Cleared May 13, 2024
MIM – Monte Carlo Dosimetry
K232862 · LLZ
Mim Software, Inc.
Radiology · 241d
Cleared May 13, 2024
Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with...
K232614 · LZA
Sri Trang Gloves (Thailand) Public...
General Hospital · 259d
Cleared May 13, 2024
Disposable Double Lumen Endobronchial Tube
K232529 · CBI
Shenzhen Insighters Medical...
Anesthesiology · 266d
Cleared May 13, 2024
BEAR 2 Body
K232242 · NFO
Foreo, Inc.
Neurology · 290d
Cleared May 10, 2024
Organic Cotton Tampon
K240708 · HEB
Suzhou Borage Medical Technology Co.,...
Obstetrics & Gynecology · 56d
Cleared May 10, 2024
SCARLET® AC-Ti
K240699 · OVE
Spineart SA
Orthopedic · 57d
Cleared May 10, 2024
Dochek® Multi-Drug Urine Test Dipcard Rx
K240698 · DJG
Guangzhou Decheng Biotechnology Co.,...
Toxicology · 57d
Cleared May 10, 2024
Access OV Monitor
K240479 · LTK
Beckman Coulter, Inc.
Immunology · 80d
Cleared May 10, 2024
Ureterorenoscope System
K240374 · FGB
Shenzhen HugeMed Medical Technical...
Gastroenterology & Urology · 93d