FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
13177–13200 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 26, 2022
Barrigel Injectable Gel
K220641 · OVB
Palette Life Sciences
Radiology · 83d
Cleared May 25, 2022
restor3d MTP Implant
K201393 · KWD
Restor3D, Inc.
Orthopedic · 728d
Cleared May 25, 2022
OptiComp
K202920 · EBF
Pac-Dent, Inc.
Dental · 603d
Cleared May 25, 2022
CRYO Arctic, CRYO Penguin
K203661 · MLY
Cryoscience North America, Inc.
Physical Medicine · 526d
Cleared May 25, 2022
Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter
K210655 · OWQ
Innovative Health, LLC
Cardiovascular · 447d
Cleared May 25, 2022
Well-life TM Pen Needles, Well-life TM Safety Pen Needles
K210748 · FMI
W. L. Med Co., Ltd.
General Hospital · 439d
Cleared May 25, 2022
Renuvion Dermal Handpiece, Renuvion Dermal System
K211652 · GEI
Apyx Medical Corporation(Formerly...
General & Plastic Surgery · 362d
Cleared May 25, 2022
Disposable Sterilized Latex Surgical Gloves
K211953 · KGO
Jiangxi Kemei Medical Apparatus &...
General Hospital · 336d
Cleared May 25, 2022
Micro-current facial cold and hot service (model: TPML-100)
K213039 · OLP
Li-Tek Electronics Technology C0., Ltd.
General & Plastic Surgery · 245d
Cleared May 25, 2022
Digital Thermometer, Models: AOJ-25A, AOJ-25B, AOJ-25C, AOJ-25D and AOJ-25E
K213485 · FLL
Shenzhen AOJ Medical Technology Co.,...
General Hospital · 208d
Cleared May 25, 2022
780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM and...
K214046 · GCJ
Stryker
General & Plastic Surgery · 149d
Cleared May 25, 2022
Single Use Ureteral Access Sheath
K220065 · FED
Zhejiang Chuangxiang Medical...
Gastroenterology & Urology · 135d
Cleared May 25, 2022
LDV((Low Dead Volume )Syringe
K220083 · QNQ
Anhui Hongyu Wuzhou Medical...
General Hospital · 135d
Cleared May 25, 2022
Paltop Conical Implant System
K220200 · DZE
Paltop Advanced Dental Solutions, Ltd.
Dental · 121d
Cleared May 25, 2022
KardiaMobile 6L
K220350 · DXH
AliveCor, Inc.
Cardiovascular · 107d
Cleared May 25, 2022
SwiftMR
K220416 · LLZ
Airs Medical, Inc.
Radiology · 100d
Cleared May 25, 2022
Remanufactured LigaSure Exact Dissector, Without Nano-coating (LF2019)
K220481 · GEI
Stryker Sustainability Solutions
General & Plastic Surgery · 96d
Cleared May 25, 2022
Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1)
K220578 · GZJ
Bozhou Rongjian Medical Appliance...
Neurology · 86d
Cleared May 25, 2022
InnoVoyce Laser Fiber
K220793 · GEX
Innovoyce, LLC
General & Plastic Surgery · 68d
Cleared May 25, 2022
Anteralign(TM) Spinal System with Titan NanoLOCK Surface Technology Navigated...
K221180 · OLO
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 30d
Cleared May 25, 2022
CD Horizon™ Spinal System
K221244 · NKB
Medtronic
Orthopedic · 23d
Cleared May 24, 2022
BENCOX Mirabo Z Cup Cortinium
K210614 · LPH
Corentec Co., Ltd.
Orthopedic · 449d
Cleared May 24, 2022
M-Vizion Monobloc
K212327 · LZO
Medacta International S.A.
Orthopedic · 301d
Cleared May 24, 2022
S-Line
K213191 · LGZ
Barkey GmbH & Co. KG
General Hospital · 237d