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
10537–10560 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 29, 2023
OverStitch NXT Endoscopic Suturing System
K231553 · OCW
Apollo Endosurgery, Inc.
General & Plastic Surgery · 30d
Cleared Jun 29, 2023
Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System
K231549 · OTN
Boston Scientific Corporation
Gastroenterology & Urology · 30d
Cleared Jun 29, 2023
Flume Catheter
K231101 · EZL
Flume Catheter Company, Ltd.
Gastroenterology & Urology · 72d
Cleared Jun 29, 2023
HotDog Warming Mattress + Return Electrode
K230866 · DWJ
Augustine Temperature Management, LLC
Cardiovascular · 92d
Cleared Jun 29, 2023
OsteoCentric ACL Fixation System
K230595 · HWC
OsteoCentric Technologies
Orthopedic · 118d
Cleared Jun 29, 2023
Coronary Dilatation Balloon Catheter (VesPenetrator®), Coronary Dilatation...
K230374 · LOX
Dongguan TT Medical, Inc.
Cardiovascular · 136d
Cleared Jun 29, 2023
EarliPoint
K230337 · QPF
Earlitec Diagnostics, Inc.
Neurology · 142d
Cleared Jun 29, 2023
Upper Arm Blood Pressure Monitor
K230176 · DXN
Shenzhen Yolanda Technology Co., Ltd.
Cardiovascular · 157d
Cleared Jun 29, 2023
SQ.line KERRISON
K223596 · HAE
Aesculap, Inc.
Neurology · 209d
Cleared Jun 29, 2023
NeuroSwift Pro
K223047 · GWN
Neurobit Technologies Co., Ltd.
Ear, Nose, Throat · 273d
Cleared Jun 29, 2023
MYAH
K222933 · MXK
Visia Imaging S.R.L.
Ophthalmic · 276d
Cleared Jun 29, 2023
F&P 950 Accessory Breathing Circuit Kits
K221436 · BZD
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 408d
Cleared Jun 28, 2023
Curiteva Laminoplasty System
K231232 · NQW
Curiteva, Inc.
Orthopedic · 61d
Cleared Jun 28, 2023
Aneroid Sphygmomanometer
K230859 · DXQ
Wenzhou Kangshun Medical Devices Co.,Ltd
Cardiovascular · 91d
Cleared Jun 28, 2023
Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KVl-5K
K230075 · DXN
Microlife Intellectual Property GmbH
Cardiovascular · 169d
Cleared Jun 28, 2023
MIO Blood Glucose Monitoring System
K223722 · NBW
Mio Labs, Inc.
Chemistry · 198d
Cleared Jun 28, 2023
Medi Lift PLUS
K220198 · NFO
Ya-Man, Ltd.
Neurology · 520d
Cleared Jun 28, 2023
Cresilon Hemostatic Gel, CHG, Cresilon Hemostatic Gel (CHG)
K213652 · QSY
Cresilon, Inc.
General & Plastic Surgery · 586d
Cleared Jun 28, 2023
e-Celsius Medical System
K210924 · FLL
Bodycap
General Hospital · 821d
Cleared Jun 27, 2023
LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal...
K231636 · NKB
L & K Biomed Co., Ltd.
Orthopedic · 22d
Cleared Jun 27, 2023
NobelZygoma PureSet™ Tray
K231219 · KCT
Nobel Biocare Services AG
General Hospital · 60d
Cleared Jun 27, 2023
Unistik® 3 Single-Use Safety Lancets:- Extra (21G), Normal (23G), Comfort...
K231124 · FMK
Owen Mumford, Ltd.
General & Plastic Surgery · 68d
Cleared Jun 27, 2023
RI.KNEE Adjustable Tibia Cut Guide
K230876 · OLO
Enztec Limited
Orthopedic · 89d
Cleared Jun 27, 2023
VADER® Pedicle System Navigated Instruments
K230861 · OLO
Icotec AG
Orthopedic · 90d