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
35761–35784 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 15, 2014
WELL LEAD HYDROPHILIC SILICONE FOLEY CATHETER
K140667 · EZL
Well Lead Medical Co., Ltd.
Gastroenterology & Urology · 272d
Cleared Dec 15, 2014
NEXTGEN ALTIUS OCT SYSTEM
K140734 · KWP
Ebi, LLC
Orthopedic · 266d
Cleared Dec 15, 2014
ENDO-CORD
K141330 · FST
Enroxtech, Inc.
General & Plastic Surgery · 208d
Cleared Dec 15, 2014
INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM
K141513 · KCT
Summit Medical, Inc.
General Hospital · 189d
Cleared Dec 15, 2014
PLAC TEST FOR LP-PLA2 ACTIVITY
K141575 · NOE
Diadexus, Inc.
Chemistry · 186d
Cleared Dec 15, 2014
BBS REVOLUTION
K142329 · IYO
Dbmedx, Inc.
Radiology · 117d
Cleared Dec 15, 2014
Intact Advance and Intact Excision XL, Intact BLES
K142477 · KNW
Intact Medical Corporation
Gastroenterology & Urology · 103d
Cleared Dec 15, 2014
ProxiFuse Hammer Toe Device
K142490 · HWC
Cartiva, Inc.
Orthopedic · 102d
Cleared Dec 15, 2014
Stabilynx PEEK Suture Anchor
K142643 · MBI
D3 Dc, LLC /Stabilynx, Inc.
Orthopedic · 89d
Cleared Dec 15, 2014
The Panthera Anti-Snoring Device
K143244 · LRK
Panthera Dental, Inc.
Dental · 33d
Cleared Dec 15, 2014
BruxZir Anterior
K143330 · EIH
Prismatik Dentalcraft, Inc.
Dental · 25d
Cleared Dec 12, 2014
SUMMED INFLATION DEVICE KIT
K133795 · MAV
Sunny Medical Device (Shenzhen) Co.,...
Cardiovascular · 364d
Cleared Dec 12, 2014
XPEED ANYRIDGE INTERNAL IMPLANT SYSYEM
K140091 · DZE
Megagen Implant Co., Ltd.
Dental · 332d
Cleared Dec 12, 2014
TRAUSIM DENTAL IMPLANT SYSTEM
K140202 · DZE
Jiangsu Trausim Medical Instrument
Dental · 319d
Cleared Dec 12, 2014
VELLA 5% SODIUM FLUORIDE VARNISH WITH NUFLUOR AND XYLITOL
K140350 · LBH
Preventive Technologies, Inc.
Dental · 304d
Cleared Dec 12, 2014
THERASNORE
K140663 · LRK
Distar, LLC
Dental · 269d
Cleared Dec 12, 2014
LEADPOINT FOCUS WORKSTSTION, LEADPOINT FOCUS NOTEBOOK SYSTEM
K140680 · GZL
Alpine Biomed Aps
Neurology · 269d
Cleared Dec 12, 2014
IPACS MEDICAL IMAGE MANAGEMENT SYSTEM
K140797 · LLZ
Visbion Limited
Radiology · 256d
Cleared Dec 12, 2014
ZHIDA NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLOR
K141303 · LZA
Zhida Glove Co., Ltd.
General Hospital · 207d
Cleared Dec 12, 2014
YONGXIN NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLOR
K141304 · LZA
Yongxin Healthcare Co., Ltd.
General Hospital · 207d
Cleared Dec 12, 2014
INFINITY EXPLORER SOFTWARE, C700 FOR IT PATIENT VICINITY WORKSTATION
K141756 · MSX
Draeger Medical Systems, Inc.
Cardiovascular · 165d
Cleared Dec 12, 2014
CONTRAST MONITORING SYSTEM DISPLAY, CONTRAST MONITORING SYSTEM SYRINGES
K142081 · DXT
Osprey Medical, Inc.
Cardiovascular · 134d
Cleared Dec 12, 2014
POOL NORM
K142132 · GGN
Diagnostics Stago S.A.S.
Hematology · 130d
Cleared Dec 12, 2014
TELESENSE
K142180 · DSI
Scottcare Corporation
Cardiovascular · 126d