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
24553–24576 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 02, 2018
Afina
K181501 · NFJ
Neurovision Imaging, LLC
Ophthalmic · 148d
Cleared Nov 02, 2018
Panta 2 Arthrodesis Nail System
K181639 · HSB
Integra LifeSciences Corporation
Orthopedic · 134d
Cleared Nov 02, 2018
Spinal Elements Ti-Bond coated devices
K181837 · MAX
Spinal Elements, Inc.
Orthopedic · 115d
Cleared Nov 02, 2018
Interlude 100% Cotton Tampon
K181911 · HEB
Albaad Fem
Obstetrics & Gynecology · 108d
Cleared Nov 02, 2018
Mazor X System (Mazor X Stealth Edition)
K182077 · OLO
Mazor Robotics , Ltd.
Orthopedic · 93d
Cleared Nov 02, 2018
Halyard Purple Nitrile Max Powder-Free Exam Gloves for Use with Chemotherapy...
K182096 · LZA
Owens & Minor Halyard, Inc.
General Hospital · 91d
Cleared Nov 02, 2018
NavLock Trackers, Robotic Reference Frame
K182104 · OLO
Medtronic Navigation
Orthopedic · 91d
Cleared Nov 02, 2018
CDI Blood Parameter Monitoring System 550
K182110 · DRY
Terumo Cardiovascular Systems...
Cardiovascular · 88d
Cleared Nov 02, 2018
CD HORIZON Spinal System Instruments for use with MAZOR X Stealth Edition
K182121 · OLO
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 88d
Cleared Nov 02, 2018
Wrist Blood Pressure Monitor Model BP6100
K182127 · DXN
Omron Healthcare, Inc.
Cardiovascular · 88d
Cleared Nov 02, 2018
Cellene CO2 Laser System
K182270 · GEX
Bio-Med USA, Inc.
General & Plastic Surgery · 72d
Cleared Nov 02, 2018
Dexcom Pro Q Continuous Glucose Monitoring System
K182405 · QDL
Dexcom, Inc.
Chemistry · 59d
Cleared Nov 02, 2018
Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound System
K182427 · IYN
Canon Medical Systems Corporation
Radiology · 57d
Cleared Nov 02, 2018
MTS Eravacycline 0.002 - 32 µg/mL
K182557 · JWY
Liofilchem S. R. L.
Microbiology · 46d
Cleared Nov 02, 2018
Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System
K182596 · IYN
Canon Medical Systems Corporation
Radiology · 43d
Cleared Nov 02, 2018
NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System
K182616 · NQQ
Ninepoint Medical, Inc.
General & Plastic Surgery · 42d
Cleared Nov 02, 2018
PRODENSE Bone Graft Substitute
K182823 · MQV
Wrightmedicaltechnologyinc
Orthopedic · 29d
Cleared Nov 01, 2018
DAEHAN Adhesive Surface Electrodes
K180247 · GXY
Daehan Medical Systems Co., Ltd.
Neurology · 276d
Cleared Nov 01, 2018
DePuy Synthes Trauma Orthopedic Plates and Screws
K180310 · HRS
Synthes (Usa) Products, LLC / Depuy...
Orthopedic · 269d
Cleared Nov 01, 2018
Clear-Tip EUS-FNA
K180363 · FCG
Finemedix Co., Ltd.
Gastroenterology & Urology · 265d
Cleared Nov 01, 2018
Spectra Optia Apheresis System
K181049 · LKN
Terumobct, Inc.
Gastroenterology & Urology · 195d
Cleared Nov 01, 2018
Implantswiss Dental Implant System, Implantswiss Dental Abutment System
K181266 · DZE
Novodent SA
Dental · 171d
Cleared Nov 01, 2018
GLUCOCARD Shine Connex Blood Glucose Monitoring System, GLUCOCARD Shine...
K181273 · NBW
I-Sens, Inc.
Chemistry · 171d
Cleared Nov 01, 2018
Medline Unite Mini Plates and Screws
K181820 · HRS
Medline Industries, Inc.
Orthopedic · 115d