FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
12601–12624 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 29, 2022
Auxilock Titanium Screw-In Suture Anchor
K213104 · MBI
Auxein Medical Private Limited
Orthopedic · 308d
Cleared Jul 29, 2022
ABMD Software
K213760 · KGI
HeartLung Corporation
Radiology · 240d
Cleared Jul 29, 2022
Microstream CO2 NanoPod
K213911 · CCK
Covidien, LLC
Anesthesiology · 226d
Cleared Jul 29, 2022
Injection Needle
K213914 · FBK
Jiangsu Vedkang Medical Science and...
Gastroenterology & Urology · 226d
Cleared Jul 29, 2022
NobelProcera Zirconia N1 Base
K220048 · NHA
Nobel Biocare Services AG
Dental · 204d
Cleared Jul 29, 2022
091 Balloon Guide Catheter
K220331 · DQY
Inneuroco, Inc.
Neurology · 175d
Cleared Jul 29, 2022
Vascette HP (hemostatic pad)
K220566 · QSY
Koag, LLC
General & Plastic Surgery · 151d
Cleared Jul 29, 2022
Dental Handpiece, Model CA160, CA160L, and CA500L
K220577 · EGS
Micro-Nx Co., Ltd.
Dental · 151d
Cleared Jul 29, 2022
OptiVu ROSA MxR
K220733 · SBF
Orthosoft Inc. (d/b/a) Zimmer CAS
Orthopedic · 137d
Cleared Jul 29, 2022
S-Core Implant System
K220901 · MBI
Subchondral Solutions, Inc.
Orthopedic · 123d
Cleared Jul 29, 2022
Deep Learning Image Reconstruction
K220961 · JAK
Ge Healthcare Japan Corporation
Radiology · 119d
Cleared Jul 29, 2022
Next Generation NetKonnect
K220989 · MHX
Nihon Kohden Digital Health...
Cardiovascular · 116d
Cleared Jul 29, 2022
Vsmilehappyzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
K221242 · EIH
Hunan Vsmile Biotechnology Co., Ltd.
Dental · 88d
Cleared Jul 29, 2022
Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C)
K221251 · NUH
Guangzhou Huakai Electronic...
Neurology · 88d
Cleared Jul 29, 2022
Dexcom G6 Continuous Glucose Monitoring (CGM) System, Dexcom G6 Glucose...
K221259 · QBJ
Dexcom, Inc.
Chemistry · 88d
Cleared Jul 29, 2022
EleGARD
K221901 · FOA
Advancedcpr Solutions, LLC
General Hospital · 29d
Cleared Jul 29, 2022
RhinAer® Stylus (FG1393)
K221907 · GEI
Aerin Medical, Inc.
Ear, Nose, Throat · 29d
Cleared Jul 29, 2022
Catapult Guide Sheath
K221914 · DYB
Contract Medical International, GmbH
Cardiovascular · 29d
Cleared Jul 28, 2022
MagXtract Collection Tube
K212113 · QBD
Magbio Genomics, Inc.
Microbiology · 386d
Cleared Jul 28, 2022
cvi42 Auto Imaging Software Application
K213998 · QIH
Circle Cardiovascular Imaging, Inc.
Radiology · 219d
Cleared Jul 28, 2022
BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial Panel
K214122 · PCI
Becton, Dickinson and Company
Microbiology · 210d
Cleared Jul 28, 2022
Single Use Cytology Brush
K220063 · FDX
Zhejiang Chuangxiang Medical...
Gastroenterology & Urology · 199d
Cleared Jul 28, 2022
TRON
K221230 · OWB
Xoran Technologies, LLC
Radiology · 90d
Cleared Jul 28, 2022
neXus Ultrasonic Surgical Aspirator System
K221235 · LFL
Misonix, Inc.
General & Plastic Surgery · 90d