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
25945–25968 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 10, 2018
OrthoPediatrics PediNail Intramedullary Platform
K172583 · HSB
Orthopediatrics, Inc.
Orthopedic · 255d
Cleared May 10, 2018
Nitrile Examination Powder Free Glove, Black, Nitrile Examination Powder Free...
K172867 · LZA
Gmp Medicare Sdn Bhd (F25)
General Hospital · 232d
Cleared May 10, 2018
UINCARE HOME
K172882 · LXJ
Uincare Corp.
Physical Medicine · 231d
Cleared May 10, 2018
ANGIO-PRESS LITE DVT Compression Device
K173012 · JOW
Pegasus Medical Supply, Inc.
Cardiovascular · 225d
Cleared May 10, 2018
OsteoMed QuickFix Hybrid MMF Sterilization Tray
K173391 · KCT
Osteomed, LLC
General Hospital · 192d
Cleared May 10, 2018
2008T BlueStar Hemodialysis Machine
K173972 · KDI
Fresenius Medical Care Renal...
Gastroenterology & Urology · 132d
Cleared May 10, 2018
FORE-SIGHT ELITE Module Tissue Oximeter
K180003 · MUD
Cas Medical Systems, Inc.
Cardiovascular · 128d
Cleared May 10, 2018
HEALIX ADVANCE KNOTLESS BR Anchor
K180101 · MAI
Medos International SARL
Orthopedic · 114d
Cleared May 10, 2018
OKTAGON Implant System
K180360 · DZE
Hager& Meisinger GmbH
Dental · 90d
Cleared May 10, 2018
Rondek PGA Suture (Beige or Violet)
K180625 · GAM
Rk Manufacturing Corporation
General & Plastic Surgery · 62d
Cleared May 10, 2018
Pro-Link® Ti Stand-Alone Cervical Spacer System
K180642 · OVE
Life Spine, Inc.
Orthopedic · 59d
Cleared May 10, 2018
Graftgun Universal Graft Delivery System
K180937 · FMF
SurGenTec, LLC
General Hospital · 30d
Cleared May 10, 2018
RadiForce MX194
K180961 · PGY
Eizo Corporation
Radiology · 28d
Cleared May 09, 2018
Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound...
K172145 · OMP
Medela AG
General & Plastic Surgery · 296d
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 CT 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