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
22801–22824 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 14, 2019
Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments
K190172 · HBE
Stryker
Neurology · 133d
Cleared Jun 14, 2019
Moss Gastrostomy Tube, Moss Nasal Tube – Mark IV
K190414 · PIF
Moss Tubes, Inc.
Gastroenterology & Urology · 113d
Cleared Jun 14, 2019
ELECTRODES PAD
K190700 · GXY
Shenzhen Bestpad Technology...
Neurology · 88d
Cleared Jun 14, 2019
Silhouette Featherlift / Silhouette Lift
K191299 · GAW
Silhouette Lift, Inc.
General & Plastic Surgery · 31d
Cleared Jun 14, 2019
AEQUALIS FLEX REVIVE Shoulder System
K191318 · KWS
Tornier, Inc.
Orthopedic · 30d
Cleared Jun 14, 2019
ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding Tube
K191387 · KNT
Envizion Medical , Ltd.
Gastroenterology & Urology · 21d
Cleared Jun 13, 2019
SeraQuest HSV Type 2 Specific IgG
K181514 · MYF
Quest International, Inc.
Microbiology · 370d
Cleared Jun 13, 2019
Restore Toothpaste
K181965 · LBH
Dr. Collins, Inc.
Dental · 325d
Cleared Jun 13, 2019
Strome-Blitzer Cytology Balloon
K182159 · EOX
Adn International, LLC
Gastroenterology & Urology · 308d
Cleared Jun 13, 2019
Oyster ACIF Cage
K182608 · ODP
Silony Medical GmbH
Orthopedic · 265d
Cleared Jun 13, 2019
Treace Medical Concepts (TMC) Snap-Off Screw System
K183363 · HWC
Treace Medical Concepts, Inc.
Orthopedic · 191d
Cleared Jun 13, 2019
ClariCT.AI
K183460 · LLZ
Claripi, Inc.
Radiology · 182d
Cleared Jun 13, 2019
XenoSure Dura Biologic Patch
K183513 · GXQ
LeMaitre Vascular, Inc.
Neurology · 177d
Cleared Jun 13, 2019
Electrosurgical Generator
K183564 · GEI
Fulwell, LLC
General & Plastic Surgery · 175d
Cleared Jun 13, 2019
Fiberoptix IAB
K190117 · DSP
Arrow International, Inc.
Cardiovascular · 140d
Cleared Jun 13, 2019
Full Automatic (NIBP) Blood Pressure Monitor-HL158UB
K190133 · DXN
Health & Life Co., Ltd.
Cardiovascular · 136d
Cleared Jun 13, 2019
Transcranial Doppler Ultrasound System
K190228 · IYN
Shenzhen Delica Medical Equipment...
Radiology · 128d
Cleared Jun 13, 2019
HealthICH
K190424 · QAS
Zebra Medical Vision, Ltd.
Radiology · 111d
Cleared Jun 13, 2019
Sonopet iQ Sterilization Tray
K190667 · KCT
Paragon Medical
General Hospital · 90d
Cleared Jun 13, 2019
ProLift® Expandable System
K191005 · MAX
Life Spine, Inc.
Orthopedic · 58d
Cleared Jun 13, 2019
SyMRI
K191036 · LNH
Syntheticmr AB
Radiology · 56d
Cleared Jun 13, 2019
Edwards Pressure Cable
K191089 · DQK
Edwards Lifesciences, LLC
Cardiovascular · 50d
Cleared Jun 13, 2019
Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope,...
K191341 · FJL
Corinth Medtech, Inc.
Gastroenterology & Urology · 24d
Cleared Jun 12, 2019
LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine reagent,...
K172232 · JGS
Ams Diagnostics
Chemistry · 687d