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
9937–9960 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 30, 2023
Unistik® ShieldLock, Unistik VacuFlip
K223854 · JKA
Owen Mumford, Ltd.
General Hospital · 189d
Cleared Jun 30, 2023
Tinearity G1 (6103)
K223694 · KLW
Duearity AB
Ear, Nose, Throat · 203d
Cleared Jun 30, 2023
Blood Pressure Monitor
K223374 · DXN
Guangdong Transtek Medical...
Cardiovascular · 238d
Cleared Jun 30, 2023
AblatePal Radiofrequency Ablation System
K223135 · GEI
Compal Electronics, Inc.
General & Plastic Surgery · 270d
Cleared Jun 30, 2023
AirTom
K222466 · QEB
Bilab
Anesthesiology · 318d
Cleared Jun 30, 2023
preCARDIA Occlusion System
K221294 · MJN
Abiomed, Inc.
Cardiovascular · 422d
Cleared Jun 30, 2023
Pixyl.Neuro
K213253 · LLZ
Pixyl SA
Radiology · 638d
Cleared Jun 30, 2023
Ulspira TS Nitric Oxide Therapy System
K212409 · MRN
Airgas Therapeutics
Anesthesiology · 696d
Cleared Jun 29, 2023
Phantom XL Insulated Dilators
K231691 · GXZ
TeDan Surgical Innovations, Inc.
Neurology · 20d
Cleared Jun 29, 2023
XENOVIEW 3.0T Chest Coil
K231647 · MOS
Polarean, Inc.
Radiology · 24d
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