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
28873–28896 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 08, 2017
UTF Stem, reduced, #0, #00
K163193 · LPH
United Orthopedic Corporation
Orthopedic · 205d
Cleared Jun 08, 2017
ASD Oral Appliances
K163580 · LRK
American Sleep Dentistry
Dental · 170d
Cleared Jun 08, 2017
Valiant Curing Light
K170101 · EBZ
Inter-Med/Vista Dental Products
Dental · 148d
Cleared Jun 08, 2017
Laser Peripherals, LLC Family of Bare Laser Fibers
K170366 · GEX
Laser Peripherals, LLC
General & Plastic Surgery · 122d
Cleared Jun 08, 2017
Sorin Connect
K170460 · DXJ
Sorin Group Deutschland GmbH
Cardiovascular · 113d
Cleared Jun 08, 2017
Novosyn Quick Absorbable Suture
K170661 · GAM
Aesculap, Inc.
General & Plastic Surgery · 97d
Cleared Jun 08, 2017
Continuous Single Culture -NX (CSCM-NX)
K170681 · MQL
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 94d
Cleared Jun 08, 2017
Gentrix Surgical Matrix Thick
K170763 · FTM
Acell, Inc.
General & Plastic Surgery · 87d
Cleared Jun 08, 2017
ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation System
K170821 · NKB
Choicespine, LP
Orthopedic · 80d
Cleared Jun 08, 2017
NuVasive CoRoent Small Interlock II System
K170961 · OVE
Nu Vasive, Incorporated
Orthopedic · 69d
Cleared Jun 08, 2017
Intraskan DC Plus
K170967 · EHD
Skanray Technologies Private Limited
Radiology · 69d
Cleared Jun 08, 2017
BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider
K171066 · GEI
Covidien, LLC
General & Plastic Surgery · 59d
Cleared Jun 08, 2017
Accuray Precision Treatment Planning System
K171086 · IYE
Accuray Incorporated
Radiology · 57d
Cleared Jun 08, 2017
Trifore(tm) Cervical Plating System
K171112 · KWQ
Neurostructures, Inc.
Orthopedic · 55d
Cleared Jun 08, 2017
Vitrea Software Toshiba Package
K171222 · LLZ
Toshibamedical Systems Corporation
Radiology · 43d
Cleared Jun 08, 2017
Quingo Flyte Mobility Scooter
K171256 · INI
Agile Distributors, LLC
Physical Medicine · 41d
Cleared Jun 07, 2017
Insulin Algorithms System
K160673 · NDC
Insulin Algorithms
General Hospital · 454d
Cleared Jun 07, 2017
Kwart Retro-Inject Ureteral Stent
K162109 · FAD
Cook Incorporated
Gastroenterology & Urology · 313d
Cleared Jun 07, 2017
Medisign GH81 Blood Glucose Monitoring System, Medisign GH82 Blood Glucose...
K162564 · NBW
Tianjin Empecs Medical Device Co., Ltd.
Chemistry · 266d
Cleared Jun 07, 2017
OneTouch Via On-Demand Insulin Delivery System
K163357 · OPP
Lifescan Europe, A Division of Cilag...
General Hospital · 189d
Cleared Jun 07, 2017
Advanced Perfusion System 1
K163531 · DTQ
Terumo Cardiovascular Systems...
Cardiovascular · 173d
Cleared Jun 07, 2017
Digital Automatic Blood Pressure Monitor MD3600
K163679 · DXN
Grandway Technology (Shenzhen) Limited
Cardiovascular · 162d
Cleared Jun 07, 2017
StentBoost Live
K170144 · OWB
Philips Medical Stystems Nederland BV
Radiology · 141d
Cleared Jun 07, 2017
SmartTarget
K170250 · LLZ
Smarttarget, Ltd.
Radiology · 131d