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
27481–27504 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 16, 2017
Symetrex Long Term Hemodialysis Catheter
K171618 · MSD
Medcomp (Dba Medical Components, Inc.)
Gastroenterology & Urology · 167d
Cleared Nov 16, 2017
Kardia Band System
K171816 · DXH
AliveCor, Inc.
Cardiovascular · 150d
Cleared Nov 16, 2017
Resorbable Mesh Device
K172130 · MQV
SeaSpine Orthopedics Corporation
Orthopedic · 125d
Cleared Nov 16, 2017
Minimally Invasive Bunion Plating System
K172178 · HRS
Trilliant Surgical, Ltd.
Orthopedic · 120d
Cleared Nov 16, 2017
Bipolar applicator CELON ProCurve V
K172535 · GEI
Olympus Winter & Ibe GmbH
General & Plastic Surgery · 86d
Cleared Nov 16, 2017
OEC Elite
K172550 · OXO
Ge Oec Medical Systems, Inc.
Radiology · 85d
Cleared Nov 16, 2017
Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components
K172634 · MBH
Howmedica Osteonics Corp. A.K.A....
Orthopedic · 76d
Cleared Nov 16, 2017
Intellijoint HIP System (Cart), Intellijoint HIP System (Portable),...
K172849 · OLO
Intellijoint Surgical, Inc.
Orthopedic · 57d
Cleared Nov 16, 2017
Reprocessed LigaSure Blunt Tip Laparoscopic Sealer/Divider
K172856 · GEI
Stryker Sustainability Solutions
General & Plastic Surgery · 57d
Cleared Nov 16, 2017
Orthofix MJ-FLEX THE NEW METAIZEAU NAIL
K173051 · HTY
Orthofix Srl
Orthopedic · 49d
Cleared Nov 16, 2017
Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses
K173136 · MRC
Menicon Co, Ltd.
Ophthalmic · 48d
Cleared Nov 16, 2017
MobileDiagnost M50
K173187 · IZL
Philips India Limited
Radiology · 45d
Cleared Nov 16, 2017
OptiCross HD, 60 MHz Coronary Imaging Catheter (Paper DFU)
K173284 · OBJ
Boston Scientific Corporation
Cardiovascular · 31d
Cleared Nov 16, 2017
LessRay System
K173314 · OWB
Nu Vasive, Incorporated
Radiology · 28d
Cleared Nov 16, 2017
KaVo NOMAD Pro 2 Handheld X-ray System
K173319 · EHD
Aribex
Radiology · 27d
Cleared Nov 16, 2017
JOURNEY II XR Knee Instruments
K173331 · JWH
Smith & Nephew, Inc.
Orthopedic · 24d
Cleared Nov 15, 2017
Arthrex FiberTape Cerclage
K170206 · JDQ
Arthrex, Inc.
Orthopedic · 295d
Cleared Nov 15, 2017
VORTEK HYDRO-COATED DOUBLE LOOP URETERAL STENTS
K170362 · FAD
Coloplast Corp.
Gastroenterology & Urology · 282d
Cleared Nov 15, 2017
Geri Embryo Incubator and Geri Dish
K171736 · MQG
Genea Biomedx Pty, Ltd.
Obstetrics & Gynecology · 156d
Cleared Nov 15, 2017
Registrado Scan
K171815 · EBF
Voco GmbH
Dental · 149d
Cleared Nov 15, 2017
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non Sterile,...
K171873 · LZA
Zhonghong Pulin Medical Products Co.,...
General Hospital · 145d
Cleared Nov 15, 2017
OverStitch SX Endoscopic Suturing System (ESS)
K171886 · OCW
Apollo Endosurgery, Inc.
General & Plastic Surgery · 142d
Cleared Nov 15, 2017
uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15,...
K171901 · MHX
Shenzhen Mindray Bio-Medical...
Cardiovascular · 142d
Cleared Nov 15, 2017
Microcyn Plus Antimicrobial Wound Care Solution
K172851 · FRO
Sonoma Pharmaceuticals, Inc.
General & Plastic Surgery · 56d