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
23617–23640 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 01, 2019
CurvaFix Intramedullary Rodscrew System
K180050 · HWC
Curvafix, Inc.
Orthopedic · 417d
Cleared Mar 01, 2019
Manual Wheelchair
K180852 · IOR
Jiangyin Newrise Medical Equipment...
Physical Medicine · 333d
Cleared Mar 01, 2019
DxH 520 Hematology Instrument
K181475 · GKZ
Beckman Coulter
Hematology · 270d
Cleared Mar 01, 2019
BD Vacutainer Eclipse UltraFill Blood Collection Needle
K181730 · FMI
Becton, Dickinson and Company
General Hospital · 245d
Cleared Mar 01, 2019
Lead-free Chemical Indicators for Steam Sterilization
K181788 · JOJ
Kem Medical Products Corp.
General Hospital · 239d
Cleared Mar 01, 2019
EliA Celikey IgG Immunoassay
K181871 · MVM
Phadia AB
Immunology · 232d
Cleared Mar 01, 2019
DTX Studio design
K181932 · PNP
Nobel Biocare AB
Dental · 225d
Cleared Mar 01, 2019
Fetal Doppler, Model FD88
K182710 · KNG
Shenzzhen Luckcome Technology Inc., Ltd.
Obstetrics & Gynecology · 155d
Cleared Mar 01, 2019
Traditional Length GJ Feeding Device
K182804 · KNT
Applied Medical Technology, Inc.
Gastroenterology & Urology · 150d
Cleared Mar 01, 2019
Guardian Angel Rx GA 1001 Digital Vital Sign Monitoring System
K182822 · DQA
Taiwan Aulisa Medical Devices...
Anesthesiology · 148d
Cleared Mar 01, 2019
Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System
K183067 · DQA
Taiwan Aulisa Medical Devices...
Anesthesiology · 116d
Cleared Mar 01, 2019
BrackFix
K183147 · DYH
Voco GmbH
Dental · 108d
Cleared Mar 01, 2019
Idys™ TLIF TiVac
K183259 · MAX
Clariance, Sas
Orthopedic · 100d
Cleared Mar 01, 2019
EP-TRACER System
K183266 · DQK
Schwarzer Cardiotek GmbH
Cardiovascular · 98d
Cleared Mar 01, 2019
Vis-U-All Low Temperature Sterilization Pouch/Tubing
K183401 · FRG
STERIS Corporation
General Hospital · 84d
Cleared Mar 01, 2019
PRO-LITE Sterilization Tray
K183402 · KCT
STERIS Corporation
General Hospital · 84d
Cleared Mar 01, 2019
ClearON Mobile
K183478 · LLZ
Rayence Co., Ltd.
Radiology · 74d
Cleared Mar 01, 2019
Tenodesis Screw System
K183690 · MBI
Paragon 28, Inc.
Orthopedic · 60d
Cleared Mar 01, 2019
Polar Care Wave
K183702 · IRP
Breg, Inc.
Physical Medicine · 60d
Cleared Mar 01, 2019
IdentiTi Porous Ti Interbody System
K183705 · MAX
Alphatec Spine, Inc.
Orthopedic · 60d
Cleared Mar 01, 2019
Vydence Laser Family
K190007 · GEX
Vydence Medical Industria E Comercio...
General & Plastic Surgery · 58d
Cleared Mar 01, 2019
ODI HD Dental Sensor
K190234 · MUH
Cnd Global Technologies, Inc.
Radiology · 23d
Cleared Feb 28, 2019
ReDS System
K180479 · DSB
Sensible Medical Innovations , Ltd.
Cardiovascular · 371d
Cleared Feb 28, 2019
Austin Miller Large External Fixation System
K181528 · KTT
Austin Miller Trauma, LLC
Orthopedic · 262d