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
21961–21984 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 27, 2019
ETEST Eravacycline (ERV) (0.002 – 32 µg/mL)
K192050 · JWY
Biomerieux S.A.
Microbiology · 58d
Cleared Sep 27, 2019
FlexBand Plus
K192112 · FTL
International Life Sciences
General & Plastic Surgery · 53d
Cleared Sep 27, 2019
ClearColor 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact...
K192129 · LPL
Clearlab SG Pte, Ltd.
Ophthalmic · 51d
Cleared Sep 27, 2019
MiniMAX
K192352 · LZO
Medacta International S.A.
Orthopedic · 29d
Cleared Sep 27, 2019
CATSmart
K192368 · CAC
Fresenius Kabi AG
Cardiovascular · 28d
Cleared Sep 27, 2019
EpiFaith Syringe
K192421 · FMF
Flat Medical Co., Ltd.
Anesthesiology · 23d
Cleared Sep 26, 2019
Dia-Proseal
K182009 · KIF
DiaDent Group International
Dental · 426d
Cleared Sep 26, 2019
Disposable Bladeless Trocar, Disposable Optical Trocar, Disposable Blunt-Tip...
K190029 · GCJ
Changzhou Xin Neng Yuan Medical...
General & Plastic Surgery · 262d
Cleared Sep 26, 2019
SepaSperm Washing Solution, SepaSperm Solution
K190199 · MQL
Kitazato Corporation
Obstetrics & Gynecology · 234d
Cleared Sep 26, 2019
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs...
K190454 · LZA
Hartalega NGC Sdn. Bhd.
General Hospital · 213d
Cleared Sep 26, 2019
PF Nitrile Exam Glove with pH coating, Black-Gray & White-Black Colors,...
K190466 · LZA
Shen Wei (Usa), Inc.
General Hospital · 212d
Cleared Sep 26, 2019
PRECICE System
K191336 · HSB
Nuvasive Specialized Orthopedics, Inc.
Orthopedic · 132d
Cleared Sep 26, 2019
StoneChecker
K191530 · LLZ
Imaging Biometrics, LLC
Radiology · 108d
Cleared Sep 26, 2019
eCarbon IBDs
K191537 · ODP
Back 2 Basics Direct, LLC
Orthopedic · 108d
Cleared Sep 26, 2019
Exogenesis Hernia Mesh
K191545 · FTL
Exogenesis Corporation
General & Plastic Surgery · 107d
Cleared Sep 26, 2019
Genesys Spine Sacroiliac Joint Fusion System
K191748 · OUR
Genesys Spine
Orthopedic · 87d
Cleared Sep 26, 2019
Sterile Dilator
K192195 · DRE
Galt Medical Corp.
Cardiovascular · 44d
Cleared Sep 26, 2019
GXR-Series Diagnostic X-Ray System
K192364 · KPR
DRGEM Corporation
Radiology · 27d
Cleared Sep 26, 2019
BioZorb SP Marker
K192371 · NEU
Focal Therapeutics
General & Plastic Surgery · 27d
Cleared Sep 26, 2019
Spectralis HRA+OCT and Variants
K192391 · OBO
Heidelberg Engineering GmbH
Ophthalmic · 23d
Cleared Sep 26, 2019
NuVasive NuvaLine
K192435 · LLZ
Nu Vasive, Incorporated
Radiology · 21d
Cleared Sep 25, 2019
NuStat
K183190 · POD
Beeken Biomedical, LLC
General & Plastic Surgery · 310d
Cleared Sep 25, 2019
3D Visualization System
K183675 · GCJ
Scivita Medical Technology Co., Ltd.
Obstetrics & Gynecology · 271d
Cleared Sep 25, 2019
LifeWindow LW8 Lite
K183687 · MWI
Digicare Biomedical Technology, Inc.
Cardiovascular · 271d