FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
24241–24264 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 02, 2018
FUJIFILM Duodenoscope Model
K182051 · FDT
Fujifilm Corporation
Gastroenterology & Urology · 63d
Cleared Oct 01, 2018
MPS2 Myocardial Protection System Console
K173716 · DTR
Quest Medical, Inc.
Cardiovascular · 300d
Cleared Oct 01, 2018
AMSure Hydrophilic Intermittent Catheter
K181445 · EZD
Amsino International, Inc.
Gastroenterology & Urology · 122d
Cleared Oct 01, 2018
StrataMR guider tool
K181622 · JXG
Medtronic Neurosurgery
Neurology · 103d
Cleared Sep 28, 2018
Kawasumi Laboratories Blood Drawing Kit (BDK) System
K172957 · KSB
Kawasumi Laboratories, Inc.
General Hospital · 367d
Cleared Sep 28, 2018
FibriCheck
K173872 · DXH
Qompium NV
Cardiovascular · 282d
Cleared Sep 28, 2018
BioCode Gastrointestinal Pathogen Panel (GPP)
K180041 · PCH
Applied BioCode, Inc.
Microbiology · 266d
Cleared Sep 28, 2018
ORISE Gel
K180068 · PLL
Boston Scientific
Gastroenterology & Urology · 262d
Cleared Sep 28, 2018
Seidmon Antegrade AQ Stent Set
K180216 · FAD
Cook Incorporated
Gastroenterology & Urology · 246d
Cleared Sep 28, 2018
Orthocaps Twinaligner
K180241 · NXC
Ortho Caps GmbH
Dental · 242d
Cleared Sep 28, 2018
Endoscope Sterilization Tray
K180964 · KCT
Intuitive Surgical, Inc.
General Hospital · 169d
Cleared Sep 28, 2018
Libertas Hip Replacement System
K180973 · JDI
Maxx Orthopedics, Inc.
Orthopedic · 168d
Cleared Sep 28, 2018
BioHorizons CAD/CAM Bars
K180998 · NHA
BioHorizons Implant Systems, Inc.
Dental · 165d
Cleared Sep 28, 2018
TSP Crosser Transseptal Access System
K181088 · DYB
Transseptal Solutions , Ltd.
Cardiovascular · 156d
Cleared Sep 28, 2018
Acessa ProVu System
K181124 · HFG
Acessa Health, Inc.
Obstetrics & Gynecology · 151d
Cleared Sep 28, 2018
E-CUBE 12
K181277 · IYN
Alpinion Medical Systems Co., Ltd.
Radiology · 137d
Cleared Sep 28, 2018
Prime&Bond active Universal Adhesive
K181476 · KLE
Dentsply Sirona
Dental · 115d
Cleared Sep 28, 2018
Coated Vicryl Plus Antibacterial (Polyglactin 910) Absorable Suture
K181652 · GAM
Ethicon, Inc.
General & Plastic Surgery · 98d
Cleared Sep 28, 2018
MICRORAPTOR Knotless Suture Anchor
K181746 · MAI
Smith and Nephew, Inc.
Orthopedic · 88d
Cleared Sep 28, 2018
RightEye Vision System
K181771 · GWN
Righteye, LLC
Ophthalmic · 87d
Cleared Sep 28, 2018
Truliant Porous Femoral Components
K181794 · MBH
Exactech, Inc.
Orthopedic · 85d
Cleared Sep 28, 2018
Arthrex Univers Revers Porous Coated Baseplate and Universal Glenoid Inlay
K182039 · PHX
Arthrex, Inc.
Orthopedic · 60d
Cleared Sep 28, 2018
Harmony
K182376 · NFJ
Topcon Medical Systems, Inc.
Ophthalmic · 28d
Cleared Sep 28, 2018
Alphenix, INFX-8000F/B, V8.0
K182415 · OWB
Canon Medical Systems Corporation
Radiology · 24d