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

Filters: Cleared only ×
175,820 results
19633–19656 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 13, 2020
Medline Powder Free Examination Gloves (Tested for use with Chemotherapy Drugs)
K200960 · LZA
Medline Industires, Inc.
General Hospital · 94d
Cleared Jul 13, 2020
Biodesign Staple Line Reinforcement
K201000 · FTM
Cook Biotech Incorporated
General & Plastic Surgery · 88d
Cleared Jul 13, 2020
PROBEAT-CR
K201042 · LHN
Hitachi , Ltd.
Radiology · 84d
Cleared Jul 13, 2020
ExacTrac Dynamic
K201276 · IYE
Brainlab AG
Radiology · 61d
Cleared Jul 13, 2020
Allograft MIS Delivery System
K201338 · FMF
Lifenet Health
General & Plastic Surgery · 54d
Cleared Jul 12, 2020
Automatic Upper Arm Blood Pressure Monitor
K193627 · DXN
Dongguan E-Test Technology Co., Ltd.
Cardiovascular · 199d
Cleared Jul 12, 2020
AGE Automatic Wrist Blood Pressure Monitor
K193628 · DXN
Dongguan E-Test Technology Co., Ltd.
Cardiovascular · 199d
Cleared Jul 10, 2020
Ezra Plexo Software
K192969 · QIH
Ezra Ai, Inc.
Radiology · 261d
Cleared Jul 10, 2020
Paragon 28 APEX 3D Total Ankle Replacement System
K192994 · HSN
Paragon 28, Inc.
Orthopedic · 259d
Cleared Jul 10, 2020
AI-Rad Companion Engine
K193294 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 226d
Cleared Jul 10, 2020
NextAR TKA Platform
K193559 · SBF
Medacta Inernational SA
Orthopedic · 200d
Cleared Jul 10, 2020
Automatic Upper Arm Blood Pressure Monitor
K193624 · DXN
Dongguan E-Test Technology Co., Ltd.
Cardiovascular · 197d
Cleared Jul 10, 2020
ExcelsiusGPS Cranial 1.0 Module
K200047 · OLO
Globus Medical, Inc.
Neurology · 183d
Cleared Jul 10, 2020
Infrascanner
K200203 · OPT
Infrascan, Inc.
Neurology · 164d
Cleared Jul 10, 2020
Pelvital System
K200409 · HIR
Pelvital USA, Inc.
Gastroenterology & Urology · 142d
Cleared Jul 10, 2020
Sonicision Cordless Ultrasonic Dissector
K200427 · LFL
Covidien, LLC
General & Plastic Surgery · 140d
Cleared Jul 10, 2020
X-Cube 90
K200449 · IYN
Alpinion Medical Systems Co., Ltd.
Radiology · 137d
Cleared Jul 10, 2020
X-Cube 70
K200450 · IYN
Alpinion Medical Systems Co., Ltd.
Radiology · 137d
Cleared Jul 10, 2020
DreamStation 2 System, DreamStation 2 Advanced System
K200480 · BZD
Respironics, Inc.
Anesthesiology · 134d
Cleared Jul 10, 2020
B&J MHP800 Deep Vein Thrombosis (DVT) Prevention System
K200568 · JOW
B&J Manufacturing , Ltd.
Cardiovascular · 128d
Cleared Jul 10, 2020
SmartLinx Vitals Plus Patient Monitoring System
K200856 · MWI
Capsule Technologie Sas
Cardiovascular · 100d
Cleared Jul 10, 2020
Disposable Specimen Retrieval Bag
K201243 · GCJ
Beijing Biosis Healing Biolog Ical...
General & Plastic Surgery · 63d
Cleared Jul 10, 2020
ASSISTO Universal Applicator Clamping Device
K201279 · JAQ
Geomed Medizin-Technik GmbH & Co. KG
Radiology · 58d
Cleared Jul 10, 2020
HD Steth
K201299 · DQD
Hd Medical, Inc.
Cardiovascular · 56d