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
7393–7416 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 12, 2024
TOSAMA Reusable Applicator
K232060 · HEB
Tosama, D.O.O.
Obstetrics & Gynecology · 276d
Cleared Apr 12, 2024
Disposable Extension Set
K222766 · FPA
Shandong Ande Healthcare Apparatus...
General Hospital · 577d
Cleared Apr 11, 2024
TiLink-P SI Joint Fusion System
K240720 · OUR
SurGenTec, LLC
Orthopedic · 27d
Cleared Apr 11, 2024
OC JuggerKnot Soft Anchor
K240719 · MBI
Riverpoint Medical
Orthopedic · 27d
Cleared Apr 11, 2024
TitanPico Laser Workstation (PICO-450)
K233757 · GEX
Rhein Laser Technologies Co., Ltd.
General & Plastic Surgery · 139d
Cleared Apr 11, 2024
True Enhance DL
K233698 · JAK
Ge Healthcare Japan Corporation
Radiology · 146d
Cleared Apr 11, 2024
Lyric4 Hearing Aid
K232999 · ESD
Sonova AG
Ear, Nose, Throat · 202d
Cleared Apr 11, 2024
Ni2 Implant System
K221847 · DZE
Newton Implant Systems, Inc.
Dental · 657d
Cleared Apr 11, 2024
Azer Scientific Universal Transport Medium
K202531 · JSM
Azer Scientific, Inc.
Microbiology · 1318d
Cleared Apr 10, 2024
CELERITY HP Indicator Tape
K240760 · JOJ
Steris
General Hospital · 21d
Cleared Apr 10, 2024
uMR 680
K240744 · LNH
Shanghai United Imaging Healthcare...
Radiology · 23d
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