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
22081–22104 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 13, 2019
NCB Plating System Distal Femur and Proximal Tibia
K192217 · HRS
Zimmer GmbH
Orthopedic · 29d
Cleared Sep 13, 2019
SIS Software Version 3.6.0
K192304 · LLZ
Surgical Information Sciences, Inc.
Radiology · 21d
Cleared Sep 12, 2019
UPnRIDE
K182257 · IPL
Upnride Robotics , Ltd.
Physical Medicine · 387d
Cleared Sep 12, 2019
Saline Wound Wash, SteriCleanse(TM)
K183662 · FRO
Ascent Consumer Products, Inc.
General & Plastic Surgery · 259d
Cleared Sep 12, 2019
OrthoAnalysis Software
K183695 · PNN
Inteware Co., Ltd.
Dental · 255d
Cleared Sep 12, 2019
Sterile Hypodermic Syringe for Single use, with/without needle, Sterile...
K190002 · FMF
Shanghai Kohope Medical Devices Co.,...
General Hospital · 253d
Cleared Sep 12, 2019
Republic Spine Restore Intervertebral Body Fusion System
K190398 · MAX
Republic Spine, LLC
Orthopedic · 205d
Cleared Sep 12, 2019
ARTIS icono
K190768 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 170d
Cleared Sep 12, 2019
syngo Application Software
K190780 · LLZ
Siemens Medical Solution USA, Inc.
Radiology · 169d
Cleared Sep 12, 2019
Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™...
K191148 · PML
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 135d
Cleared Sep 12, 2019
MectaLock Ti Suture Anchor
K191300 · MBI
Medacta International S.A.
Orthopedic · 121d
Cleared CT Sep 12, 2019
Revolution Peripheral Atherectomy System, Revolution Peripheral Atherectomy...
K191419 · MCW
Rex Medical, L.P.
Cardiovascular · 107d
Cleared Sep 12, 2019
Ali Interbody Fusion System
K191516 · MAX
Raed M. Ali, M.D., Inc.
Orthopedic · 97d
Cleared Sep 12, 2019
CO2 Laser System
K191518 · GEX
Shenzhen Gsd Tech Co., Ltd.
General & Plastic Surgery · 97d
Cleared Sep 12, 2019
L360 Thigh System
K191587 · GZI
Bioness, Inc.
Neurology · 90d
Cleared Sep 12, 2019
faceLITE
K191629 · OHS
Ismart Marketing Svcs, Ltd.
General & Plastic Surgery · 85d
Cleared Sep 12, 2019
mont blanc & mont blanc MIS Spinal Systems
K191726 · NKB
Spineway SA
Orthopedic · 77d
Cleared Sep 12, 2019
Capillus 112, Capillus 244
K192012 · OAP
Capillus
General & Plastic Surgery · 45d
Cleared Sep 12, 2019
CRC PC Smart Chamber K1
K192199 · KPT
Capintec, Inc.
Radiology · 30d
Cleared Sep 12, 2019
uDR 592h, uDR 596i
K192293 · KPR
Shanghai United Imaging Healthcare...
Radiology · 20d
Cleared Sep 11, 2019
PeraMobile and PeraWatch
K183370 · MWI
Perahealth, Inc.
Cardiovascular · 281d
Cleared Sep 11, 2019
CNAP Monitor
K183521 · DXN
Cnsystems Medizintechnik GmbH
Cardiovascular · 266d
Cleared CT Sep 11, 2019
BrainScope TBI
K190815 · PIW
Brainscope Company, Inc.
Neurology · 166d
Cleared Sep 11, 2019
Ceribell Pocket EEG Device
K191301 · OMB
Ceribell, Inc.
Neurology · 120d