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
24457–24480 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 14, 2018
Miracu
K172602 · NEW
Feeltech Co., Ltd.
General & Plastic Surgery · 441d
Cleared Nov 14, 2018
Apoller Flow Light Cure Flowable Composite
K180463 · EBF
Greenway Yw, LLC
Dental · 266d
Cleared Nov 14, 2018
Invacare® Solara® 3G and Solara® 3G Spree Manual Wheelchairs
K181090 · IOR
Invacare Corporation
Physical Medicine · 203d
Cleared Nov 14, 2018
SporView Rapid Read Biological Indicator SteamPlus Test Pack
K181434 · FRC
Crosstex/Spsmedical, A Division of...
General Hospital · 166d
Cleared Nov 14, 2018
HPM-6000UF
K181497 · KPI
BTL Industries, Inc.
Gastroenterology & Urology · 160d
Cleared Nov 14, 2018
Velofix TLIF Cage
K181829 · MAX
U&I Corporation
Orthopedic · 128d
Cleared Nov 14, 2018
Inversa Implants
K181850 · DZE
Southern Implants (Pty), Ltd.
Dental · 126d
Cleared Nov 14, 2018
VivaSight-DL System
K181886 · CBI
Etview , Ltd.
Anesthesiology · 124d
Cleared Nov 14, 2018
ostaPek Interbody Fusion Cages
K181963 · MAX
Coligne AG
Orthopedic · 114d
Cleared Nov 14, 2018
React 71 Catheter
K182097 · DQY
Micro Therapeutics, Inc. d/b/a ev3...
Neurology · 103d
Cleared Nov 14, 2018
Riptide Aspiration System (React 71 Catheter)
K182101 · NRY
Micro Therapeutics, Inc. d/b/a ev3...
Neurology · 103d
Cleared Nov 14, 2018
JO Naturalove Personal Lubricant, JO Naturalove Strawberry Fields Flavored...
K182105 · NUC
United Consortium
Obstetrics & Gynecology · 103d
Cleared Nov 14, 2018
Wearable Device
K182543 · MSX
Snap40, Ltd.
Cardiovascular · 58d
Cleared Nov 14, 2018
Z6 Diagnostic Ultrasound System
K182603 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 54d
Cleared Nov 14, 2018
New Era
K182604 · GEX
Step UP Skin Laser, LLC
General & Plastic Surgery · 54d
Cleared Nov 14, 2018
Voyant Maryland Fusion Device
K182653 · GEI
Applied Medical Resources Corp.
General & Plastic Surgery · 50d
Cleared Nov 14, 2018
CrystalView Pro Irrigation Console, CrystalView Pro Autoclavable Remote Control
K182882 · HRX
Conmed Corporation
General & Plastic Surgery · 30d
Cleared Nov 13, 2018
Handheld Pulse Oximeter, Model SP-20
K172792 · DQA
Shenzhen Creative Industry Co., Ltd.
Anesthesiology · 424d
Cleared Nov 13, 2018
RectalPro 75 Endorectal Balloon
K180478 · PCT
Qlrad International , Ltd.
Radiology · 264d
Cleared Nov 13, 2018
Immucise Intradermal Injection System
K181369 · FMI
Terumo Corporation
General Hospital · 174d
Cleared Nov 13, 2018
Aspire Venting Tube
K182248 · KNT
Aspire Bariatrics, Inc.
Gastroenterology & Urology · 85d
Cleared Nov 13, 2018
Saxxony™ Posterior Cervical Thoracic System
K182508 · NKG
Nexxt Spine, LLC
Orthopedic · 62d
Cleared Nov 13, 2018
VersaLink™ Fixation System
K182598 · NKB
Premia Spine, Ltd.
Orthopedic · 54d
Cleared Nov 13, 2018
Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens, Largan U38...
K182674 · LPL
Largan Medical Co., Ltd.
Ophthalmic · 48d