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
29185–29208 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 08, 2017
VariAx 2 Foot System
K170771 · HRS
Stryker GmbH
Orthopedic · 55d
Cleared May 08, 2017
Thermi Reusable Non-invasive RF Electrode
K171094 · GEI
Thermgen, L.L.C
General & Plastic Surgery · 26d
Cleared May 05, 2017
MINISCAV
K160950 · CBN
Sedation Systems, LLC
Anesthesiology · 395d
Cleared May 05, 2017
Rusch Silicone Foley Catheter
K161770 · EZL
Teleflexmedical, Inc.
Gastroenterology & Urology · 311d
Cleared May 05, 2017
Solero MTA System, Solero Microwave Tissue Ablation Applicator (14cm), Solero...
K162449 · NEY
AngioDynamics, Inc.
General & Plastic Surgery · 246d
Cleared May 05, 2017
Kent Camera
K163070 · MUD
Kent Imaging, Inc.
Cardiovascular · 184d
Cleared May 05, 2017
A08 Power wheelchair
K163204 · ITI
Kunshan Aoshida Electric Technology...
Physical Medicine · 171d
Cleared May 05, 2017
Colink™ Plating System
K163293 · HRS
In2bones USA, LLC
Orthopedic · 164d
Cleared May 05, 2017
Internal Distraction - Sterile
K163315 · PBJ
KLS-Martin L.P.
Neurology · 163d
Cleared May 05, 2017
ImmunoCAP Allergen w1, Common ragweed
K163370 · DHB
Phadia AB
Immunology · 155d
Cleared May 05, 2017
MATRx plus
K163665 · MNR
Zephyr Sleep Technologies
Anesthesiology · 129d
Cleared May 05, 2017
Nanova Screw-In Suture Anchor, Nanova Push-In Suture Anchor
K163672 · MAI
Nanova Biomaterials, Inc.
Orthopedic · 129d
Cleared May 05, 2017
Softcure 96
K170068 · ILY
Wellray Medical Laser, Inc.
Physical Medicine · 116d
Cleared May 05, 2017
POLYCHLOROPRENE POWDER FREE SURGICAL GLOVE (GREEN)
K170152 · KGO
Hartalega Sdn Bhd
General Hospital · 108d
Cleared May 05, 2017
SICAGE™ System
K170475 · OUR
Sicage, LLC
Orthopedic · 78d
Cleared May 05, 2017
LENSAR Laser System - fs 3D (LLS-fs 3D)
K170576 · OOE
Lensar, Inc.
Ophthalmic · 67d
Cleared May 05, 2017
In Reach
K170789 · JAK
Curvebeam, LLC
Radiology · 50d
Cleared May 05, 2017
Medical Video Endoscope System
K171076 · FGB
Zhuhai Pusen Medical Technology Co.,...
Gastroenterology & Urology · 24d
Cleared May 05, 2017
Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS...
K171082 · NKB
Orthofix, Inc.
Orthopedic · 24d
Cleared May 04, 2017
Restore Moisturizing Vaginal Lubricant
K162207 · NUC
Good Clean Love
Obstetrics & Gynecology · 272d
Cleared May 04, 2017
Cedic Enteral ENFit Transition Connectors
K162254 · PIO
Cedic S.R.L.
Gastroenterology & Urology · 267d
Cleared May 04, 2017
Flex Robotic System and Flex Colorectal Drive
K162330 · FDF
Medrobotics Corporation
Gastroenterology & Urology · 258d
Cleared May 04, 2017
Foundation 3D Interbody
K162496 · ODP
Corelink, LLC
Orthopedic · 239d
Cleared May 04, 2017
Eclipse Kiss Zirconia
K163238 · EIH
Ams
Dental · 167d