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

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175,820 results
15937–15960 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 18, 2021
Hypodermic Safety Needle
K211555 · MEG
Anhui Hongyu Wuzhou Medical...
General Hospital · 152d
Cleared Oct 18, 2021
LOQTEQ Proximal Humerus Plate 3.5 System
K211582 · HRS
Aap Implantate AG
Orthopedic · 150d
Cleared Oct 18, 2021
Surgical Gown
K211809 · FYA
Wuhan Dymex Healthcare Co., Ltd.
General Hospital · 129d
Cleared Oct 18, 2021
Change Healthcare Cardiology
K212528 · LLZ
Change Healthcare Israel , Ltd.
Radiology · 68d
Cleared Oct 18, 2021
ClotTriever Thrombectomy System
K212632 · QEW
Inari Medical, Inc.
Cardiovascular · 60d
Cleared Oct 18, 2021
0909FCB, 1212FCA
K212753 · MQB
Rayence Co., Ltd.
Radiology · 48d
Cleared Oct 15, 2021
MultiSure GK Link Blood Glucose and Ketone Monitoring System
K201880 · NBW
Apex BioTechnology Corp.
Chemistry · 465d
Cleared Oct 15, 2021
Aqueduct 200 Cervical Dilation Balloon Catheter
K202433 · PON
Gtimd, LLC
Obstetrics & Gynecology · 416d
Cleared Oct 15, 2021
Arm Blood Pressure Monitor
K210563 · DXN
Alicn Medical (Shenzhen), Inc.
Cardiovascular · 232d
Cleared Oct 15, 2021
Deka Tiac II
K211091 · PBX
El.En Electronic Engineering Spa
General & Plastic Surgery · 186d
Cleared Oct 15, 2021
RM4 Control Unit
K211224 · KDN
Institut Georges Lopez
Gastroenterology & Urology · 175d
Cleared Oct 15, 2021
HIVOX OTC Electrical Stimulator, FT610-B
K211403 · NUH
Hivox Biotek, Inc.
Neurology · 162d
Cleared Oct 15, 2021
Ortho MI System
K211992 · OAT
Osteonic Co., Ltd.
Dental · 109d
Cleared Oct 15, 2021
Magicore System
K212517 · DZE
Innobiosurg Co., Ltd.
Dental · 66d
Cleared Oct 15, 2021
ViaCath, AcQRate Dx Steerable Catheter
K212593 · DRF
Biotronick, Inc.
Cardiovascular · 60d
Cleared Oct 15, 2021
CORUS Spinal System-X
K212636 · HRX
Providence Medical Technology, Inc.
Orthopedic · 57d
Cleared Oct 15, 2021
ACUSON AcuNav Volume Intracardiac Echocardiography(ICE) Catheter
K212959 · OBJ
Siemens Medical Solutions USA, Inc.
Cardiovascular · 29d
Cleared Oct 15, 2021
AxTiHA Stand-Alone ALIF System
K212967 · OVD
Innovasis, Inc.
Orthopedic · 29d
Cleared Oct 14, 2021
AFS Medical Sterile Single-Use Access Port System
K202688 · OTJ
Afs Medical Co. , Ltd.
General & Plastic Surgery · 394d
Cleared Oct 14, 2021
Brainance MD
K202808 · LLZ
Advantis Medical Imaging Single...
Radiology · 386d
Cleared Oct 14, 2021
Vittra APS Unique
K210231 · EBF
Dentscare Ltda
Dental · 259d
Cleared Oct 14, 2021
SwiftMR
K210999 · LLZ
Airs Medical, Inc.
Radiology · 195d
Cleared Oct 14, 2021
Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special...
K211121 · PTI
Intera Oncology, Inc.
General Hospital · 182d
Cleared Oct 14, 2021
ALGO 7i
K211147 · GWJ
Path Medical GmbH
Ear, Nose, Throat · 178d