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
28489–28512 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 18, 2017
HEALIX ADVANCE Anchor with PERMATAPE Suture
K170639 · MAI
Medos International SARL
Orthopedic · 77d
Cleared May 18, 2017
The Solstice OCT System
K170804 · NKG
Life Spine, Inc.
Orthopedic · 62d
Cleared May 18, 2017
Lipogems System
K171135 · MUU
Lipogems International Spa
General & Plastic Surgery · 31d
Cleared May 18, 2017
LaparoLight Veress Needle
K171139 · HIF
Buffalo Filter, LLC
Obstetrics & Gynecology · 30d
Cleared May 18, 2017
SmartByte Device
K171165 · ONY
Scientific Intake
Gastroenterology & Urology · 28d
Cleared May 17, 2017
AirLife Misty Finity Nebulizer
K153748 · CAF
Care Fusion
Anesthesiology · 505d
Cleared May 17, 2017
MRI Compatibility for Existing Zimmer Dental Implant Systems
K160398 · DZE
Zimmer Dental, Inc.
Dental · 460d
Cleared May 17, 2017
Dynamika
K161601 · LLZ
Image Analysis Limited
Radiology · 342d
Cleared May 17, 2017
FREND PSA PLUS (reagent cartridge)
K162378 · LTJ
Nanoentek USA, Inc.
Immunology · 266d
Cleared May 17, 2017
TinniLogic Mobile Tinnitus Management Device
K163094 · KLW
Jiangsu Betterlife Medical Co., Ltd.
Ear, Nose, Throat · 194d
Cleared May 17, 2017
Humeris Shoulder
K163669 · PHX
Fx Solutions
Orthopedic · 141d
Cleared May 17, 2017
Medisono Color Doppler Ultrasound System, models P11 Portable, P11 EXPERT...
K170078 · IYN
Medisono, LLC
Radiology · 128d
Cleared May 17, 2017
Test of Variables of Attention (T.O.V.A.) Version 9.0
K170082 · LQD
The Tova Company
Neurology · 127d
Cleared May 17, 2017
QuantX
K170195 · LLZ
Quantitative Insights, Inc.
Radiology · 114d
Cleared May 17, 2017
A&D Medical UB-1100BLE UltraConnect Digital Blood Pressure Monitor
K170196 · DXN
A&D Company, Ltd.
Cardiovascular · 114d
Cleared May 17, 2017
Cardiac Trigger Monitor
K170828 · DRT
Ivy Biomedical Systems, Inc.
Cardiovascular · 58d
Cleared May 17, 2017
Nexus DR Digital X-ray Imaging System
K171138 · MQB
Varex Imaging Corporation
Radiology · 29d
Cleared May 17, 2017
Surefire Precision Infusion System
K171355 · DQO
Surefire Medical, Inc.
Cardiovascular · 8d
Cleared May 16, 2017
VerteFIT Corpectomy Cage System
K162133 · MQP
Ldr Spine USA, Inc.
Orthopedic · 288d
Cleared May 16, 2017
Kangaroo Feeding Tube with IRIS Technology
K163002 · KNT
Covidien (Dba Medtronic)
Gastroenterology & Urology · 200d
Cleared May 16, 2017
TRANSLACE™ Spinal Tethering System
K163181 · OWI
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 183d
Cleared May 16, 2017
EPIC Extremely Small Staple
K163226 · JDR
Epic Extremely, LLC
Orthopedic · 180d
Cleared May 16, 2017
iSR'obot Biopsy Kit
K163502 · ITX
Biobot Surgical Pte., Ltd.
Radiology · 153d
Cleared May 16, 2017
Direxion and Direxion HI-FLO Torqueable Microcatheters
K163701 · KRA
Boston Scientific Corporation
Cardiovascular · 138d