FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
7129–7152 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 10, 2024
SAFECARE Fentanyl Urine Test Cassette
K240654 · NGL
Safecare Biotech (Hangzhou) Co., Ltd.
Toxicology · 34d
Cleared Apr 10, 2024
Face Patches (MT-12MA, MT-12MC)
K240089 · OHS
Shenzhen Kaiyan Medical Equipment...
General & Plastic Surgery · 89d
Cleared Apr 10, 2024
NIRVANA
K234057 · GEX
El.En S.P.A.
General & Plastic Surgery · 110d
Cleared Apr 10, 2024
8Q10 Surclear Smoke Plume Evacuation System
K233789 · FYD
Surnic Corporation
General Hospital · 134d
Cleared Apr 10, 2024
3D Optical Coherence Tomography (3D OCT-1(type: Maestro2))
K233561 · OBO
Topcon Corporation
Ophthalmic · 156d
Cleared Apr 10, 2024
Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer...
K233509 · MAX
Zavation Medical Products, LLC
Orthopedic · 162d
Cleared Apr 10, 2024
Keikku Electronic stethoscope
K233313 · DQD
Lapsi Health Holding B.V.
Cardiovascular · 194d
Cleared Apr 10, 2024
Neorad Pacs (Neorad Pacs)
K232641 · LLZ
Everrtech Software Pvt, Ltd.
Radiology · 224d
Cleared Apr 10, 2024
Sodium Chloride Inhalation Solution, USP 0.9%, 3% & 7%
K232523 · CAF
Mankind Pharma Limited
Anesthesiology · 236d
Cleared Apr 10, 2024
Electromagnetic Stimulation Systems
K232409 · NGX
Shanghai Apolo Medical Technology...
Physical Medicine · 244d
Cleared Apr 09, 2024
GalaFLEX LITE Scaffold
K233999 · OOD
Tepha, Inc.
General & Plastic Surgery · 113d
Cleared Apr 09, 2024
Disposable Trocars
K233263 · GCJ
Hangzhou Kangji Medical Instrument...
General & Plastic Surgery · 193d
Cleared Apr 09, 2024
Universal Endometrial Applicator Set (GM11009840)
K232623 · JAQ
Varian Medical Systems, Inc.
Radiology · 224d
Cleared Apr 09, 2024
TransForm McCarthy Mitral Annuloplasty Ring (TF)
K232599 · KRH
Genesee Biomedical, Inc.
Cardiovascular · 225d
Cleared Apr 09, 2024
CAAS Workstation
K232147 · QHA
Pie Medical Imaging BV
Radiology · 265d
Cleared Apr 08, 2024
TDM Anterior Cervical Plate System
K240423 · KWQ
Tdm Co., Ltd.
Orthopedic · 55d
Cleared Apr 08, 2024
EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM
K240291 · QAS
Ever Fortune.Ai, Co., Ltd.
Radiology · 67d
Cleared Apr 08, 2024
Powder Free Nitrile Examination Glove 3.5, Blue Color, Non-Sterile, and...
K240021 · LZA
Yue Kang Anhui Medical Products Co.,...
General Hospital · 96d
Cleared Apr 08, 2024
BiWaze Clear System
K231728 · NHJ
Abmrc, LLC
Anesthesiology · 300d
Cleared Apr 08, 2024
Sample preservation solution
K212878 · QBD
Zhejiang Gene Science Co., Ltd.
Microbiology · 942d
Cleared Apr 05, 2024
G Surgical Marksman MIS System
K240737 · NKB
G Surgical, LLC
Orthopedic · 18d
Cleared Apr 05, 2024
Virage® Navigation System
K240647 · OLO
Zimvie Spine (Zimmer Biomet Spine, Inc.)
Orthopedic · 29d
Cleared Apr 05, 2024
Wrinkle Treatment Device (JM2)
K240360 · OHS
Shenzhen Qianyu Technology Co., Ltd.
General & Plastic Surgery · 59d
Cleared Apr 05, 2024
ACESO Early Pregnancy Test
K234152 · LCX
Aceso Laboratories, Inc.
Chemistry · 98d