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
33745–33768 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 07, 2015
Philips Spectral CT Applications
K150665 · JAK
Philips Medical Systems Nethrlands BV
Radiology · 144d
Cleared Aug 07, 2015
Assure Prism multi Blood Glucose Monitoring System
K151164 · NBW
I-Sens, Inc.
Chemistry · 98d
Cleared Aug 07, 2015
Synchro-Medical TIGER TRACK Screw System
K151241 · HWC
Synchro Medical
Orthopedic · 88d
Cleared Aug 07, 2015
syngo.MR Neurology, syngo.MR Oncology
K151353 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 79d
Cleared Aug 07, 2015
.decimal p.d
K151369 · MUJ
.Decimal, LLC
Radiology · 78d
Cleared Aug 07, 2015
Corvocet Coaxial Introducer
K151373 · FCG
Merit Medical Systems, Inc.
Gastroenterology & Urology · 78d
Cleared Aug 07, 2015
Selectra Catheters and Selectra Accessory Kit
K151409 · DQY
Biotronik, Inc.
Cardiovascular · 73d
Cleared Aug 07, 2015
Digital Automatic Wrist Blood Pressure Monitor MD3900
K151583 · DXN
Grandway Technology (Shenzhen) Limited
Cardiovascular · 57d
Cleared Aug 07, 2015
Digital Automatic Wrist Blood Pressure Monitor MD3200
K151587 · DXN
Grandway Technology (Shenzhen) Limited
Cardiovascular · 57d
Cleared Aug 07, 2015
8ch Foot Ankle Coil
K151653 · MOS
Shenzhen RF Tech Co., Ltd.
Radiology · 50d
Cleared Aug 07, 2015
Shielded Applicator Set, Cervical Stop
K151657 · JAQ
Varian Medical Systems, Inc.
Radiology · 49d
Cleared Aug 07, 2015
Precision Spine Interspinous Plate System
K151863 · PEK
Precision Spine, Inc.
Orthopedic · 30d
Cleared Aug 07, 2015
STA R MAX
K151867 · JPA
Diagnostica Stago S.A.S
Hematology · 29d
Cleared Aug 07, 2015
MicroTract Access System
K151877 · DRE
Arstasis, Inc.
Cardiovascular · 29d
Cleared Aug 07, 2015
Wingman Crossing Catheter
K151880 · DQY
Reflow Medical
Cardiovascular · 29d
Cleared Aug 07, 2015
Q-Rad Radiographic System with Auto-Tracker Option
K151924 · KPR
Quantum Medical Imaging Divison of...
Radiology · 25d
Cleared Aug 07, 2015
Confida Adaptive Sheath
K152054 · DYB
Medtronic, Inc.
Cardiovascular · 15d
Cleared Aug 06, 2015
GAL-1F Blood Glucose Monitoring System, GAL-1F Pro Blood Glucose Monitoring...
K142689 · CGA
Apex BioTechnology Corp.
Chemistry · 318d
Cleared Aug 06, 2015
Elecsys CA-125 II assay
K143534 · LTK
Roche Professional Diagnostics
Immunology · 237d
Cleared Aug 06, 2015
Total Knee Application (TKA)
K143752 · OLO
Mako Surgical Corp.
Orthopedic · 218d
Cleared Aug 06, 2015
ReDs Wearable System
K150095 · DSB
Sensible Medical Innovations , Ltd.
Cardiovascular · 202d
Cleared Aug 06, 2015
EUM 100Pro
K150398 · HGM
Ob Tools, Ltd.
Obstetrics & Gynecology · 169d
Cleared Aug 06, 2015
Reveal LINQ
K150614 · MXD
Medtronic, Inc.
Cardiovascular · 149d
Cleared Aug 06, 2015
Triglycerides
K150819 · CDT
Randox Laboratories Limited
Chemistry · 132d