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
25849–25872 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 23, 2018
DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips
K181024 · JIL
DFI Co., Ltd.
Chemistry · 35d
Cleared May 23, 2018
geko T-3 Neuromuscular Stimulator
K181059 · IPF
Firstkind Limited
Physical Medicine · 30d
Cleared May 23, 2018
AlignX Ankle Fusion System
K181067 · HRS
Extremity Medical, LLC
Orthopedic · 30d
Cleared May 22, 2018
DiLumen Endolumenal Interventional Scissors (DiLumen Is)
K173405 · GEI
Lumendi, LLC
General & Plastic Surgery · 203d
Cleared May 22, 2018
Pantheris System
K173862 · MCW
Avinger, Inc.
Cardiovascular · 153d
Cleared May 22, 2018
Cellvizio 100 Series Systems with Confocal Miniprobes
K180270 · GWG
Mauna Kea Technologies
Neurology · 111d
Cleared May 22, 2018
NeuralBot
K180455 · IYN
Neural Analytics, Inc.
Radiology · 91d
Cleared May 22, 2018
Arthrex FastThread Interference Screw
K180662 · MAI
Arthrex, Inc.
Orthopedic · 69d
Cleared May 22, 2018
Reusable and Self-Adhesive Electrodes
K180773 · GXY
Shaoxing Dongzhi Electrical...
Neurology · 60d
Cleared May 22, 2018
Omni Foot Plating System
K180808 · HRS
Extremity Medical, LLC
Orthopedic · 55d
Cleared May 21, 2018
Polypectomy Snare
K172729 · FDI
Hangzhou AGS MedTech Co., Ltd.
Gastroenterology & Urology · 252d
Cleared May 21, 2018
MECALL CLISIS SYSTEMS, Discovery RF180
K173395 · JAA
General Medical Merate S.P.A
Radiology · 203d
Cleared May 21, 2018
stay•safe catheter extension set with Safe-Lock, 12 inch, stay•safe catheter...
K173593 · KDJ
Fresenius Medical Care Renal...
Gastroenterology & Urology · 181d
Cleared May 21, 2018
Biowy PlCC Catheter
K173956 · LJS
Biowy Corporation
General Hospital · 144d
Cleared CT May 21, 2018
Erchonia FX-635
K180197 · NHN
Erchonia Corporation
Physical Medicine · 117d
Cleared May 21, 2018
SAGICO OSI Spinal System by Osimplant
K180220 · NKB
Spinal Analytics & Geometrical...
Orthopedic · 116d
Cleared May 21, 2018
VACUETTE SAFELINK Holder with male luer lock
K180545 · FMI
Greiner Bio-One Na, Inc.
General Hospital · 81d
Cleared May 21, 2018
AERIAL™ Interspinous Fixation
K180817 · PEK
Globus Medical, Inc.
Orthopedic · 53d
Cleared May 18, 2018
AURA ICP MONITORING SYSTEM
K172209 · GWM
Branchpoint Technologies, Inc.
Neurology · 298d
Cleared May 18, 2018
ArgenIS Titanium Abutments
K172430 · NHA
Argen Corporation
Dental · 280d
Cleared May 18, 2018
Esophageal Stent System
K172813 · ESW
Micro-Tech (Nanjing) Co., Ltd.
Gastroenterology & Urology · 242d
Cleared May 18, 2018
Smoklean
K173108 · FYD
Sejong Medical Co., Ltd.
General Hospital · 231d
Cleared May 18, 2018
GRAFTSITE
K173110 · BSP
Summit Medical , Ltd.
Anesthesiology · 231d
Cleared May 18, 2018
Magnesium
K173294 · JGJ
Abbott Laboratories
Chemistry · 214d