Search FDA 510(k) Database

7,162 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
22801–22824 of 174,061
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
Cleared Nov 01, 2018
N Latex FLC kappa assay, N Latex FLC lambda assay
K182098 · DFH
Siemens Healthcare Diagnostics...
Immunology · 90d
Cleared Nov 01, 2018
MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD...
K182273 · DXT
Bayer Medical Care, Inc.
Cardiovascular · 71d
Cleared Nov 01, 2018
MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit
K182276 · DXT
Bayer Medical Care, Inc.
Cardiovascular · 71d
Cleared Nov 01, 2018
Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens
K182523 · LPL
Largan Medical Co., Ltd.
Ophthalmic · 49d
Cleared Oct 31, 2018
AVIEW
K171199 · LLZ
Coreline Soft Co., Ltd.
Radiology · 555d
Cleared Oct 31, 2018
LUXEN Zr, LUXEN Smile
K171585 · EIH
Dentalmax Co., Ltd.
Dental · 518d
Cleared Oct 31, 2018
Panpac Flexi Shelf Pessary
K173351 · HHW
Panpac Medical Corporation
Obstetrics & Gynecology · 371d