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
26905–26928 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 22, 2018
EZ Plate
K173306 · KWQ
Zavation Medical Products, LLC
Orthopedic · 96d
Cleared Jan 22, 2018
3M Attest Super Rapid Readout Biological Indicator, 3M Attest Auto-reader, 3M...
K173584 · FRC
3M Company
General Hospital · 63d
Cleared Jan 22, 2018
Centurion POCT System
K180025 · NKG
Orthofix, Inc.
Orthopedic · 19d
Cleared CT Jan 19, 2018
Fiji Anchor
K171228 · MAI
Sportwelding GmbH
Orthopedic · 268d
Cleared Jan 19, 2018
LINK® BiMobile(TM) Dual Mobility System
K171273 · MEH
Waldemar Link GmbH & Co. KG
Orthopedic · 263d
Cleared Jan 19, 2018
FUJIFILM Bronchoscope Model EB-530P
K171291 · EOQ
Fujifilm Medical Systems U.S.A, Inc.
Ear, Nose, Throat · 262d
Cleared CT Jan 19, 2018
EM-4000 Specular Microscope
K171313 · NQE
Tomey Corporation
Ophthalmic · 260d
Cleared Jan 19, 2018
Focus Cap
K171673 · FDF
Gce Medical Corporation
Gastroenterology & Urology · 227d
Cleared Jan 19, 2018
Angel Align System
K171674 · NXC
Smile Development Corp
Dental · 227d
Cleared Jan 19, 2018
KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit
K171731 · OIF
Kronus, Inc.
Chemistry · 221d
Cleared Jan 19, 2018
Straumann Dental Implant System
K171784 · DZE
Straumann USA, LLC
Dental · 218d
Cleared Jan 19, 2018
ReddyPort NIV Access Elbow
K171827 · MNS
Smd Manufacturing, LLC
Anesthesiology · 213d
Cleared Jan 19, 2018
FORZA® XP Expandable Spacer System
K172696 · MAX
Orthofix, Inc.
Orthopedic · 134d
Cleared CT Jan 19, 2018
DRI OCT Triton
K173119 · OBO
Topcon Corporation
Ophthalmic · 112d
Cleared Jan 19, 2018
Choice Spine Laminoplasty™ Fixation System
K173215 · NQW
Choicespine, LP
Orthopedic · 109d
Cleared Jan 19, 2018
Reliance Lumbar IBF System
K173283 · MAX
Reliance Medical Systems, LLC
Orthopedic · 95d
Cleared Jan 19, 2018
BioSphere MIS Putty (BioSphere MIS)
K173301 · MQV
Synergy Biomedical, LLC
Orthopedic · 94d
Cleared Jan 19, 2018
OnSight 3D Extremity System
K173478 · JAK
Carestream Health, Inc.
Radiology · 67d
Cleared Jan 19, 2018
PENTAX Medical Video Bronchoscopes, PENTAX Medical Video...
K173554 · EOQ
Pentax of America, Inc.
Ear, Nose, Throat · 63d
Cleared Jan 19, 2018
DIP Arthrodesis System
K173616 · HTY
In2bones Sas
Orthopedic · 58d
Cleared Jan 19, 2018
GENFlex2 Total Knee System - Ultra-Congruent CR Tibial Insert
K173875 · JWH
Stelkast, Inc.
Orthopedic · 29d
Cleared Jan 19, 2018
PreXion3D Excelsior
K173878 · OAS
Prexion Corporation
Radiology · 29d
Cleared Jan 19, 2018
Gel-Bead (600-800 micron) - 1 ml sphere volume, Gel-Bead (600-800 micron) - 2...
K173891 · KRD
Vascular Solutions, Inc.
Cardiovascular · 29d
Cleared Jan 18, 2018
Pelvifine Pelvic Muscle Trainer
K163288 · KPI
Shenzhen Konmed Technology Co., Ltd.
Gastroenterology & Urology · 422d