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
6817–6840 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 18, 2024
MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Spray MDI Adapter
K233553 · CAF
Thayer Medical Corporation
Anesthesiology · 225d
Cleared Jun 18, 2024
Automatic Biopsy Needle BAM, Semi-Automatic Needle BIM
K233294 · KNW
Itp Innovative Tomography Products GmbH
General & Plastic Surgery · 263d
Cleared Jun 18, 2024
Ultrasonic Surgical System
K233036 · LFL
Hunan Handlike Minimally Invasive...
General & Plastic Surgery · 267d
Cleared Jun 17, 2024
AllTest Multi-Drug Urine Test Cup
K241428 · NFT
Hangzhou AllTest Biotech Co., Ltd.
Toxicology · 28d
Cleared Jun 17, 2024
Ion 3D
K241416 · MRW
SurGenTec, LLC
Orthopedic · 31d
Cleared Jun 17, 2024
Medical Diode Laser (M2-GK)
K240747 · GEX
Wuhan Pioon Technology Co., Ltd.
General & Plastic Surgery · 90d
Cleared Jun 17, 2024
Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9...
K240684 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 97d
Cleared Jun 17, 2024
VERABAND™
K233987 · LEL
Arbor Medical Innovations, LLC
Neurology · 182d
Cleared Jun 17, 2024
MediOMx
K233331 · LLZ
Pmx, Inc.
Radiology · 262d
Cleared Jun 17, 2024
Molecular Transport Media - MTM
K233324 · QBD
Alb Luz
Microbiology · 262d
Cleared Jun 17, 2024
Robotic Integration Instruments
K233256 · OLO
DePuy Synthes
Orthopedic · 263d
Cleared Jun 17, 2024
CROSSNAV Navigation Enabled Instruments
K233255 · OLO
DePuy Synthes
Orthopedic · 263d
Cleared Jun 17, 2024
Elecsys Folate III
K233060 · CGN
Roche Diagnostics
Chemistry · 266d
Cleared Jun 17, 2024
XO Constrain™ Percutaneous Transluminal Angioplasty Constraining Catheter
K232258 · PNO
Transit Scientific, LLC
Cardiovascular · 322d
Cleared Jun 15, 2024
iQ 2 Nasal Vented Mask
K241469 · BZD
Sleepnet Corporation
Anesthesiology · 22d
Cleared Jun 15, 2024
Multi-parameter detector
K231116 · MNW
Zhongshan Jinli Electronic Weighing?...
Cardiovascular · 422d
Cleared Jun 14, 2024
Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)
K241407 · GEX
Bios S.R.L.
General & Plastic Surgery · 28d
Cleared Jun 14, 2024
3DMax Light Mesh
K241250 · FTL
Davol Inc., Subsidiary of C. R. Bard,...
General & Plastic Surgery · 42d
Cleared Jun 14, 2024
SIS System
K241083 · QIH
Surgical Information Sciences, Inc.
Radiology · 56d
Cleared Jun 14, 2024
INNOVERSE Navigation Instruments
K241082 · OLO
Innosys Co., Ltd.
Orthopedic · 56d
Cleared Jun 14, 2024
VersaWrap
K240817 · OWW
Alafair Biosciences, Inc.
Orthopedic · 81d
Cleared Jun 14, 2024
Electronic Blood Pressure Monitor (Model: PG-800B30, PG-800B38, PG-800B39,...
K240729 · DXN
Shenzhen Pango Medical Electronics...
Cardiovascular · 88d
Cleared Jun 14, 2024
ExcelsiusFlex™
K240721 · OLO
Globus Medical, Inc.
Orthopedic · 88d
Cleared Jun 14, 2024
Airdog X8 Air Purifier (KJ800F-X8)
K240696 · FRF
Suzhou Beiang Smart Technology Co., Ltd.
General Hospital · 92d