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
32257–32280 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 12, 2016
Powder Free Nitrile Patient Examination Gloves, Blue Color
K151680 · LZA
Suqian Xingye Glove Co,Ltd
General Hospital · 235d
Cleared Feb 12, 2016
MetaFix LS Locking Screws, Merete Cannulated PCS, Merete CS Cortical Screws,...
K152187 · HWC
Merete Medical GmbH
Orthopedic · 191d
Cleared Feb 12, 2016
Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 Guidewire
K152231 · DQX
Boston Scientific Corporation
Cardiovascular · 189d
Cleared Feb 12, 2016
Adena-Zina System
K152781 · NKB
Shanghai Sanyou Medical Co, Ltd.
Orthopedic · 140d
Cleared Feb 12, 2016
Clear Guide SCENERGY
K153004 · JAK
Clear Guide Medical
Radiology · 122d
Cleared Feb 12, 2016
Microlife Upper Arm Automatic Digital Blood Pressure Monitor
K153077 · DXN
Microlife Intellectual Property GmbH
Cardiovascular · 112d
Cleared Feb 12, 2016
CARESTREAM Vue PACS
K153103 · LLZ
Carestream Health, Inc.
Radiology · 109d
Cleared Feb 12, 2016
Arthrex Synergy UHD4 System
K153218 · GCJ
Arthrex, Inc.
General & Plastic Surgery · 99d
Cleared Feb 12, 2016
PTFE Super Sheath Introducer 2.1
K153246 · DYB
Medcomp (Medical Components, Inc.)
Cardiovascular · 95d
Cleared Feb 12, 2016
HS SutureTape
K153307 · GAT
Riverpoint Medical
General & Plastic Surgery · 88d
Cleared Feb 12, 2016
BD Vacutainer UltraTouch Push Button Blood Collection Set
K153309 · JKA
Becton, Dickinson and Company
Chemistry · 87d
Cleared Feb 12, 2016
Relieva Scout Multi-Sinus Dilation System
K153341 · LRC
Acclarent, Inc.
Ear, Nose, Throat · 85d
Cleared Feb 12, 2016
WHILL Model M
K153543 · ITI
Whill, Inc.
Physical Medicine · 63d
Cleared Feb 12, 2016
Vitoss BiModal Bone Graft Substitute Foam Strip
K153608 · MQV
Orthovita, Inc.
Orthopedic · 57d
Cleared Feb 12, 2016
Single Use Injector NM600/610
K153625 · FBK
Olympus Medical Systems Corp.
Gastroenterology & Urology · 56d
Cleared Feb 12, 2016
Spirit Hair Removal laser Family
K153718 · GEX
Active Optical Systems , Ltd.
General & Plastic Surgery · 46d
Cleared Feb 12, 2016
TraumaCad Mobile Release 2.0
K160001 · LLZ
Voyant Health, Ltd.
Radiology · 39d
Cleared Feb 12, 2016
Digital Electrocardiograph
K160092 · DPS
Shenzhen Biocare Bio-Medical...
Cardiovascular · 28d
Cleared Feb 11, 2016
Dimension Vista LOCI Total Testosterone Flex reagent cartridge, Dimension...
K151529 · CDZ
Siemens Healthcare Diagnostics, Inc.
Chemistry · 248d
Cleared Feb 11, 2016
Biotrue ONEday with NaturMoist, Biotrue ONEday for Presbyopia with...
K151918 · LPL
Bausch & Lomb, Incorporated
Ophthalmic · 213d
Cleared Feb 11, 2016
ARCHITECT SHBG
K152185 · CDZ
Biokit, S.A.
Chemistry · 190d
Cleared Feb 11, 2016
Dental Implant System
K152555 · DZE
Ariabio International, Inc.
Dental · 156d
Cleared Feb 11, 2016
C-VBR
K152568 · PLR
Cardinal Spine, LLC
Orthopedic · 155d
Cleared Feb 11, 2016
OptoWire Deux
K152991 · DQX
Opsens
Cardiovascular · 121d