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
18169–18192 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 15, 2021
PERLA® TL posterior osteosynthesis system
K203506 · NKB
Spineart
Orthopedic · 46d
Cleared Jan 15, 2021
ViewPoint 6
K203677 · LLZ
GE Medical Systems Ultrasound &...
Radiology · 29d
Cleared Jan 15, 2021
CD HORIZON™ Spinal System
K203678 · NQP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 29d
Cleared Jan 15, 2021
CarboClear Lumbar Cage System
K203683 · MAX
Carbofix Orthpedics , Ltd.
Orthopedic · 29d
Cleared Jan 14, 2021
EasyPath RF Introducer Sheath
K200702 · EOQ
Broncus Medical, Inc.
Ear, Nose, Throat · 302d
Cleared Jan 14, 2021
Vital Sleep
K201719 · LRK
The Snore Reliever Company, LLC
Dental · 205d
Cleared Jan 14, 2021
Trophikos Vaginal Moisturizer
K201922 · NUC
Trophikos, LLC
Obstetrics & Gynecology · 188d
Cleared Jan 14, 2021
Maven Patient-Specific Instrumentation
K202019 · HSN
Paragon 28, Inc.
Orthopedic · 177d
Cleared Jan 14, 2021
BioGuard EUS Air/Water and Suction Valves
K202104 · ODC
STERIS Corporation
Gastroenterology & Urology · 169d
Cleared Jan 14, 2021
Lockado Repositionable Hemostasis Clip
K202333 · PKL
Micro-Tech (Nanjing) Co., Ltd.
Gastroenterology & Urology · 150d
Cleared Jan 14, 2021
Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment...
K202694 · GZT
Vycor Medical, Inc.
Neurology · 120d
Cleared Jan 14, 2021
ART-Plan
K202700 · QKB
Therapanacea
Radiology · 120d
Cleared Jan 14, 2021
VELYS™ Robotic-Assisted Solution
K202769 · OLO
Depuy Ireland UC
Orthopedic · 115d
Cleared Jan 14, 2021
OmniGuide BeamPath OTO-U Fiber
K203241 · GEX
Omniguide, Inc.
General & Plastic Surgery · 72d
Cleared Jan 14, 2021
Mobius3D
K203669 · IYE
Varian Medical Systems, Inc.
Radiology · 29d
Cleared Jan 13, 2021
Polyisoprene Powder Free, Black Colour Surgical Gloves
K192933 · KGO
Emerson & Co. Srl
General Hospital · 454d
Cleared Jan 13, 2021
ENTity WiFi Video Nasopharyngoscope System
K200609 · EOB
Optim, LLC
Ear, Nose, Throat · 310d
Cleared Jan 13, 2021
MyOnyx System
K201014 · KPI
Thought Technology , Ltd.
Gastroenterology & Urology · 271d
Cleared Jan 13, 2021
BEGO Semados® RS/RSX Implant System
K201700 · DZE
Bego Implant Systems GmbH & Co. KG
Dental · 205d
Cleared Jan 13, 2021
Procedure face mask (Model: KKF-2A)
K202314 · FXX
Han Zhaoqing Sporting Goods Company...
General Hospital · 149d
Cleared Jan 13, 2021
Inion CompressOn Screw
K203105 · HWC
Inion OY
Orthopedic · 90d
Cleared Jan 13, 2021
StealthStation Cranial Software v1.3.2
K203639 · HAW
Medtronic Navigation, Inc.
Neurology · 30d
Cleared Jan 13, 2021
M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System
K203671 · OUR
Medacta International S.A.
Orthopedic · 28d
Cleared Jan 12, 2021
Disposable Medical Surgical Mask
K201625 · FXX
Tianjin Saiyuan Technology Co., Ltd.
General Hospital · 211d