FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
7873–7896 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 15, 2024
EMPHASYS™ Dual Mobility System
K231522 · LPH
Depuy Ireland UC
Orthopedic · 265d
Cleared Feb 15, 2024
Bronchoscope System
K231107 · EOQ
Hunan Endoso Life Technology Co., Ltd.
Ear, Nose, Throat · 302d
Cleared Feb 15, 2024
PBC Separator with Selux AST System
K223493 · QZX
Selux Diagnostics, Inc.
Microbiology · 451d
Cleared Feb 15, 2024
Breathing circuit bacterial/viral filter
K222917 · CAH
Shaoxing Haitech Medical Products...
General Hospital · 507d
Cleared Feb 14, 2024
airVata™
K240427 · LRK
Gelb Practice Solutions, Inc.
Dental · 1d
Cleared Feb 14, 2024
Radiography 7000 M
K233678 · IZL
Philips Medical Systems Dmc GmbH
Radiology · 90d
Cleared Feb 14, 2024
Azure
K231514 · GEX
Daeshin Enterprise Co., Ltd.
General & Plastic Surgery · 265d
Cleared Feb 13, 2024
Easi-Vue® embolic microspheres System
K234123 · KRD
Abk Biomedical, Inc.
Cardiovascular · 47d
Cleared Feb 13, 2024
M.U.S.T. Pedicle Screw System - Extension
K234048 · NKB
Medacta International S.A.
Orthopedic · 54d
Cleared Feb 13, 2024
EPi-Ease Epicardial Access Device (EAS)
K233959 · DYB
AtriCure, Inc.
Cardiovascular · 60d
Cleared Feb 13, 2024
Chemi-SiL (HB, MB, LB, LBS)
K233954 · ELW
B&E Korea Co., Ltd.
Dental · 60d
Cleared Feb 13, 2024
EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic...
K233788 · IYN
Philips Ultrasound, LLC
Radiology · 77d
Cleared Feb 13, 2024
Black Nitrile Powder Free Patient Examination Glove, Non Sterile
K233740 · LZA
W.A. Rubbermate Co., Ltd.
General Hospital · 83d
Cleared Feb 13, 2024
Transorb™ Self-Gripping Resorbable Mesh
K233661 · OWT
Sofradim Production
General & Plastic Surgery · 90d
Cleared Feb 13, 2024
EXPD 4343S
K232082 · MQB
DRTECH Corporation
Radiology · 215d
Cleared Feb 13, 2024
Apex Locator
K231990 · LQY
Cefla S.C.
Dental · 223d
Cleared Feb 13, 2024
QOCA® image Smart RT Contouring System
K231855 · QKB
Quanta Computer, Inc.
Radiology · 235d
Cleared Feb 13, 2024
VerteLoc Spinal System
K231134 · MQP
Signature Orthopaedics Pty, Ltd.
Orthopedic · 298d
Cleared Feb 12, 2024
Facial Toning device (UIC-189)
K233667 · NFO
Body Trim Industrial Co., Ltd.
Neurology · 89d
Cleared Feb 12, 2024
SPY Cystoscope/Hysteroscope
K233635 · HIH
Stryker Endoscopy
Obstetrics & Gynecology · 91d
Cleared Feb 12, 2024
NerveTape
K233533 · JXI
Biocircuit Technologies, Inc.
Neurology · 102d
Cleared Feb 12, 2024
Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile)
K233401 · IYO
Eieling Technology Limited
Radiology · 131d
Cleared Feb 12, 2024
Univers Revers CA Head and Adapter
K233260 · HSD
Arthrex, Inc.
Orthopedic · 136d
Cleared Feb 12, 2024
Mimics Cardiac Planner
K233217 · LLZ
Materialise NV
Radiology · 137d