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
25369–25392 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 09, 2018
STERIZONE VP4 Sterilizer
K172191 · PJJ
Tso3, Inc.
General Hospital · 293d
Cleared May 09, 2018
CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia...
K173202 · JPA
Sekisui Medical Co., Ltd.
Hematology · 219d
Cleared May 09, 2018
Faxitron VisionCT
K173309 · MWP
Faxitron Bioptics, LLC
Radiology · 203d
Cleared May 09, 2018
ARTHRO-Pump PA304
K173311 · HRX
W.O.M. World of Medicine GmbH
Orthopedic · 203d
Cleared May 09, 2018
EmboTrap ll Revascularization Device
K173452 · NRY
Neuravi, Ltd.
Neurology · 184d
Cleared May 09, 2018
DSM Biomedical Calcium Phosphate Cement with Microspheres
K173572 · MQV
Kensey Nash Corporation Dba Dsm...
Orthopedic · 170d
Cleared May 09, 2018
Silk'n MODEL H5003 device
K180279 · NGX
Home Skinovations , Ltd.
Physical Medicine · 98d
Cleared May 09, 2018
Navi e/Navi s/Navi X Diagnostic Ultrasound System
K180461 · IYN
Shenzhen Wisonic Medical Technology...
Radiology · 78d
Cleared May 09, 2018
VSI Micro-Introducer Kit
K180913 · DYB
Vascular Solutions, Inc.
Cardiovascular · 30d
Cleared May 09, 2018
Klassic HD® Hip System
K180929 · LZO
Total Joint Orthopedics, Inc.
Orthopedic · 30d
Cleared May 09, 2018
Diamond Orthopedic Bone Fixation Screws and Pins
K180932 · HWC
Diamond Orthopedic, LLC
Orthopedic · 29d
Cleared May 09, 2018
Halcyon
K181032 · IYE
Varian Medical Systems, Inc.
Radiology · 21d
Cleared May 08, 2018
Trident Extremity Fixation System
K171690 · HRS
Trident Orthopedics
Orthopedic · 335d
Cleared May 08, 2018
VENTANA CD30 (Ber-H2) RxDx Assay
K172471 · DEH
Ventana Medical Systems, Inc.
Medical Genetics · 266d
Cleared May 08, 2018
A-CIFT SoloFuse
K172484 · OVE
Spinefrontier, Inc.
Orthopedic · 264d
Cleared May 08, 2018
Fetzer Medical Gynecological Forceps
K172661 · HCZ
Fetzer Medical GmbH & Co. KG
Obstetrics & Gynecology · 245d
Cleared May 08, 2018
SB Soft Hood - Straight type, SB Soft Hood - Undercut type
K173004 · FDS
Sumitomo Bakelite Co., Ltd.
Gastroenterology & Urology · 223d
Cleared May 08, 2018
STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX,...
K173347 · MAX
Centinel Spine, Inc.
Orthopedic · 195d
Cleared May 08, 2018
BioStamp nPoint
K173510 · DRG
Mc10, Inc.
Cardiovascular · 176d
Cleared May 08, 2018
Glidesheath Slender
K173831 · DYB
Terumo Medical Corporation
Cardiovascular · 141d
Cleared May 08, 2018
MyoSure MANUAL Tissue Removal Device
K173901 · HIH
Hologic, Inc.
Obstetrics & Gynecology · 137d
Cleared May 08, 2018
BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc...
K173912 · JOH
Smiths Medical Asd, Inc.
Anesthesiology · 137d
Cleared May 08, 2018
Meron Plus QM
K180386 · EMA
Voco GmbH
Dental · 85d
Cleared May 08, 2018
Empower H100, Cyber Ho 100, Litho 100
K180922 · GEX
Quanta System Spa
General & Plastic Surgery · 29d