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
28393–28416 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 03, 2017
Arzzt 3.5 / 4.5 Small & Large Fragments System
K162507 · HRS
Truemed Group, LLC
Orthopedic · 329d
Cleared Aug 03, 2017
Everyway OTC EMS, Model EV-805
K162744 · NGX
Everyway Medical Instrument Co., Ltd.
Physical Medicine · 307d
Cleared Aug 03, 2017
The TiBow Expandable Spacer System
K170919 · MAX
Life Spine, Inc.
Orthopedic · 127d
Cleared Aug 03, 2017
CADence System
K170928 · DQD
Aum Cardiovascular, Inc.
Cardiovascular · 127d
Cleared Aug 03, 2017
U-Lite EXP
K171164 · IYN
Sonoscanner
Radiology · 105d
Cleared Aug 03, 2017
eCareManager 4.1
K171322 · MSX
Visicu, Inc.
Cardiovascular · 90d
Cleared Aug 03, 2017
Clarity Reveal
K171356 · LLZ
Ceevra, Inc.
Radiology · 86d
Cleared Aug 03, 2017
dpl II Panel
K171390 · OHS
Led Technologies, Inc.
General & Plastic Surgery · 84d
Cleared Aug 03, 2017
Thunderbolt™ Minimally Invasive and Lancer™ Open Pedicle Screw Systems
K171456 · NKB
Choicespine
Orthopedic · 78d
Cleared Aug 03, 2017
Medrobotics Flex Robotic System
K172036 · FDF
Medrobotics Corporation
Gastroenterology & Urology · 29d
Cleared Aug 03, 2017
CATHTONG II PICC Catheter
K172039 · LJS
L&Z Us, Inc.
General Hospital · 29d
Cleared Aug 02, 2017
731 Series Ventilators
K162832 · CBK
ZOLL Medical Corporation
Anesthesiology · 295d
Cleared Aug 02, 2017
Healgen Multi-Drug Urine Test Cup
K163704 · JXM
Healgen Scientific, LLC
Toxicology · 216d
Cleared Aug 02, 2017
Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe...
K170651 · MEG
Yangzhou Medline Industry, Co., Ltd.
General Hospital · 152d
Cleared Aug 02, 2017
Accutorr 7/VS-900 Vital Signs Monitor
K170712 · MWI
Shenzhen Mindray Bio-Meidcal...
Cardiovascular · 146d
Cleared Aug 02, 2017
Hearing Healthcare Pro
K171038 · ETY
Db Diagnostic Systems, Inc.
Ear, Nose, Throat · 118d
Cleared Aug 02, 2017
Skyn Original Polyisoprene Lubricated Male Condom - Flavored
K171172 · MOL
Ansell Healthcare Products, LLC
Obstetrics & Gynecology · 103d
Cleared Aug 02, 2017
M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System
K171595 · OUR
Medacta International S.A.
Orthopedic · 63d
Cleared Aug 02, 2017
AUTOCON III 400
K171717 · GEI
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 54d
Cleared Aug 02, 2017
truSculpt
K172004 · PBX
Cutera, Inc.
General & Plastic Surgery · 30d
Cleared Aug 01, 2017
AED Sinuscope
K170285 · EOB
National Advanced Endoscopy Devices,...
Ear, Nose, Throat · 183d
Cleared Aug 01, 2017
LifeWatch Mobile Cardiac Telemetry 3 Lead LifeWatch MCT 3L
K170565 · QYX
Lifewatch Services, Inc.
Cardiovascular · 155d
Cleared Aug 01, 2017
DD cubeX2 HS
K170885 · EIH
Dental Direkt GmbH
Dental · 127d
Cleared Aug 01, 2017
Zirconia Dental Ceramics
K170894 · EIH
Chengdu Besmile Biotechnology Co., Ltd.
Dental · 127d