FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
29353–29376 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 20, 2017
Sterile Single-use Infusion Set
K163160 · FPA
Jiangxi Hongda Medical Equipment...
General Hospital · 161d
Cleared Apr 20, 2017
HEM-9210T
K163235 · DXN
Omron Healthcare, Inc.
Cardiovascular · 154d
Cleared CT Apr 20, 2017
SlimShape System
K163415 · GEI
Syneron Medical, Ltd.
General & Plastic Surgery · 136d
Cleared Apr 20, 2017
Ortho System
K163677 · PNN
3Shape A/S
Dental · 114d
Cleared Apr 20, 2017
DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound...
K163690 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 113d
Cleared Apr 20, 2017
QiF Blood and Fluid Warmer
K163708 · LGZ
Quality IN Flow , Ltd.
General Hospital · 112d
Cleared Apr 19, 2017
TEG 6s Hemostasis System
K160502 · JPA
Haemonetics Corporation
Hematology · 421d
Cleared Apr 19, 2017
VisioFocus Mini, VisioFocus Smart
K160680 · FLL
Tecnimed S.R.L.
General Hospital · 405d
Cleared Apr 19, 2017
Ortho System
K161884 · MQC
3Shape A/S
Dental · 282d
Cleared Apr 19, 2017
GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System,...
K163383 · HRS
Greens Surgicals Pvt. , Ltd.
Orthopedic · 139d
Cleared Apr 19, 2017
Stellaris Elite vision enhancement system
K170052 · HQC
Bausch & Lomb
Ophthalmic · 104d
Cleared Apr 19, 2017
LaserDock, HolmiumDock, CO2Dock,OmniDock, KTPDock
K170215 · GEX
Patient Pocket, LLC
General & Plastic Surgery · 85d
Cleared Apr 18, 2017
Finapres Nova Noninvasive Hemodynamic Monitor
K160967 · DXN
Finapres Medical Systems B.V.
Cardiovascular · 377d
Cleared Apr 18, 2017
NovoGro
K162087 · MQV
Osteonovus, Inc.
Orthopedic · 264d
Cleared Apr 18, 2017
OmniPod Insulin Management System
K162296 · LZG
Insulet Corporation
General Hospital · 245d
Cleared Apr 18, 2017
Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator...
K162297 · PTF
Diazyme Laboratories
Microbiology · 245d
Cleared Apr 18, 2017
PICO Single Use Negative Pressure Wound Therapy System
K163387 · OMP
Smith & Nephew Medical Limited
General & Plastic Surgery · 137d
Cleared Apr 18, 2017
ECHELON CIRCULAR Powered Stapler
K163523 · GDW
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 124d
Cleared Apr 18, 2017
EndoRotor
K170120 · PTE
Interscope, Inc.
Gastroenterology & Urology · 95d
Cleared Apr 18, 2017
Lacriflow CL
K170247 · OKS
Kaneka Pharma America, LLC
Ophthalmic · 81d
Cleared Apr 18, 2017
Plato MICROCATH 27B Microcatheter
K170406 · DQO
Scientia Vascular, LLC
Cardiovascular · 67d
Cleared Apr 18, 2017
Model 330 Multifunction Aspirator
K170533 · BTA
ZOLL Medical Corporation
General & Plastic Surgery · 54d
Cleared Apr 18, 2017
Mako Total Hip Application
K170593 · OLO
Mako Surgical Corp.
Orthopedic · 49d
Cleared Apr 17, 2017
Pressio 2 ICP Monitoring System
K162108 · GWM
Sophysa SA
Neurology · 262d