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

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175,820 results
29953–29976 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 09, 2017
Hubble I System
K163566 · NKB
Orbbo Surgical, LLC
Orthopedic · 52d
Cleared Feb 09, 2017
Pinnacle Radiation Therapy Planning System
K170086 · MUJ
Philips Medical Systems (Cleveland),...
Radiology · 30d
Cleared Feb 09, 2017
UA-Cellular Complete
K170091 · JJW
Streck
Chemistry · 30d
Cleared Feb 09, 2017
pixium 4343RCE
K170113 · MQB
Philips Medical Systems Dmc GmbH
Radiology · 28d
Cleared Feb 08, 2017
FB-U Hemodialyzer
K160444 · KDI
Nipro Medical Corporation
Gastroenterology & Urology · 357d
Cleared Feb 08, 2017
MyNeWT Negative Pressure Wound Therapy System
K161432 · OMP
Stortford Medical, LLC
General & Plastic Surgery · 260d
Cleared Feb 08, 2017
Transformair Indoor Air Purifier
K161468 · FRA
Transformair, LLC
General Hospital · 257d
Cleared Feb 08, 2017
Arm-Type Fully Automatic Digital Blood Pressure Monitor
K161577 · DXN
Sejoy Electronics & Instruments Co.,...
Cardiovascular · 246d
Cleared Feb 08, 2017
OptosAdvance 4.0 Software
K162039 · NFJ
Optos Plc.
Ophthalmic · 201d
Cleared Feb 08, 2017
Smart Pain Reliever, Model LT5019
K162479 · NUH
Shenzhen Dongdixin Technology Co., Ltd.
Neurology · 155d
Cleared Feb 08, 2017
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue)
K162491 · LZA
Hartalega Sdn Bhd
General Hospital · 154d
Cleared Feb 08, 2017
Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D...
K162840 · MRG
Roche Diagnostics
Chemistry · 120d
Cleared Feb 08, 2017
Finessis Zero Chemo Flexylon Powder Free Sterile White Surgical Glove
K162852 · KGO
Lucenxia Prescience AG
General Hospital · 120d
Cleared Feb 08, 2017
Fully Automatic Electronic Blood Pressure Monitor
K162915 · DXN
Andon Health Co, Ltd.
Cardiovascular · 114d
Cleared Feb 08, 2017
Handheld Diode Laser for Hair Removal
K163173 · OHT
Liaoning Sidey Optoelectronics...
General & Plastic Surgery · 86d
Cleared Feb 08, 2017
VIVIX-S 1417N
K163703 · MQB
Vieworks Co., Ltd.
Radiology · 41d
Cleared Feb 07, 2017
PUREtrace™
K153262 · OSP
Nemo Healthcare BV
Obstetrics & Gynecology · 455d
Cleared Feb 07, 2017
EndyGel
K161715 · GYB
Endymed Medical, Ltd.
Neurology · 231d
Cleared Feb 07, 2017
Fuselier Intraoral Nighttime Device (FIND)
K161980 · LRK
Fuselier Enterprises, LLC
Dental · 204d
Cleared Feb 07, 2017
Proficient™ Posterior Cervical Spine System
K162639 · NKG
Spine Wave, Inc.
Orthopedic · 138d
Cleared Feb 07, 2017
Zilver 518TM Biliary Stent
K163169 · FGE
Cook Ireland, Ltd.
Gastroenterology & Urology · 85d
Cleared Feb 07, 2017
Unicare System, Unicare Manipulator
K163214 · LKF
Clearpath Surgical, Inc.
Obstetrics & Gynecology · 83d
Cleared Feb 07, 2017
Fitmore® Hip Stem
K170072 · KWY
Zimmer GmbH
Orthopedic · 29d
Cleared Feb 06, 2017
UC-CARE NaviGo Workstation
K160934 · LLZ
UC-CARE , Ltd.
Radiology · 308d