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
19729–19752 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 29, 2020
Twin-Pass Dual Access Catheter
K193119 · DQY
Vascular Solutions, LLC
Cardiovascular · 230d
Cleared Jun 29, 2020
Arthrex DynaNite K-Wire
K200068 · HTY
Arthrex, Inc.
Orthopedic · 168d
Cleared Jun 29, 2020
Electronic stimulator
K200354 · NUH
Shenzhen Dongjilian Electronics Co.,...
Neurology · 137d
Cleared Jun 29, 2020
Echelon Contour Curved Cutter with blue reload, Echelon Contour Curved Cutter...
K200420 · GDW
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 130d
Cleared CT Jun 29, 2020
Somnera System
K200698 · QBY
Fresca Medical, Inc.
Anesthesiology · 104d
Cleared Jun 29, 2020
ARTIS pheno (VE2)
K201156 · OWB
Siemens Medical Solution USA, Inc.
Radiology · 60d
Cleared Jun 29, 2020
MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32...
K201423 · LTT
Beckman Coulter, Inc.
Microbiology · 31d
Cleared Jun 29, 2020
Edge Air(1417) Digital Flat Panel X-ray Detector
K201503 · MQB
Osko, Inc.
Radiology · 24d
Cleared Jun 29, 2020
Cadence Total Ankle System
K201507 · HSN
Integra LifeSciences Corporation
Orthopedic · 24d
Cleared Jun 27, 2020
OMNIBotics Knee System
K200888 · OLO
Corin, Ltd.
Orthopedic · 85d
Cleared Jun 26, 2020
JDentalCare Implant System JDIcon
K182081 · DZE
Jdentalcare Srl
Dental · 694d
Cleared Jun 26, 2020
MSDI Dental Implants System
K191443 · DZE
Medical Systems and Devices...
Dental · 393d
Cleared Jun 26, 2020
Optimized Positioning System (OPS) ReView
K193042 · LLZ
Corin USA
Radiology · 239d
Cleared Jun 26, 2020
LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx...
K193473 · MXD
Boston Scientific Corporation
Cardiovascular · 193d
Cleared Jun 26, 2020
Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200...
K193525 · CZP
HORIBA ABX SAS
Immunology · 190d
Cleared Jun 26, 2020
EndoGI Biliary Stent System
K193600 · FGE
Endogi Medical, Ltd.
Gastroenterology & Urology · 186d
Cleared Jun 26, 2020
Streamline Navigated Instruments
K200095 · OLO
Pioneer Surgical Technology, Inc....
Orthopedic · 162d
Cleared Jun 26, 2020
RetroFix
K200226 · HWC
Retrofix Screws, LLC
Orthopedic · 148d
Cleared Jun 26, 2020
Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne...
K200250 · FYD
Megadyne Medical Products, Inc.
General Hospital · 144d
Cleared Jun 26, 2020
D-Stat Radial Topical Hemostat
K200720 · QSX
Vascular Solutions, LLC
General & Plastic Surgery · 99d
Cleared Jun 26, 2020
StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762)
K200723 · PGW
Medtronic Navigation, Inc.
Ear, Nose, Throat · 99d
Cleared Jun 26, 2020
Stardust Med
K200736 · GEX
I.T.S. Group S.R.L.
General & Plastic Surgery · 95d
Cleared Jun 26, 2020
Rapid ASPECTS
K200760 · POK
Ischemaview, Inc.
Radiology · 94d
Cleared Jun 26, 2020
NOVEOS Specific IgE (sIgE), Capture Reagent Cat Dander - E001, Felis Domesticus
K200825 · DHB
Hycor Biomedical
Immunology · 88d