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
7105–7128 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 12, 2024
OASIS MRI System
K240571 · LNH
Fujifilm Healthcare Corporation
Radiology · 43d
Cleared Apr 12, 2024
Ceramic Femoral Head
K240452 · LZO
Microport Orthopedics, Inc.
Orthopedic · 57d
Cleared Apr 12, 2024
UltraThineer Zirconia Slurry (5Y-B)
K240419 · EIH
Boston Micro Fabrication
Dental · 59d
Cleared Apr 12, 2024
Stryker Orthopaedics Hip Systems Labeling Update
K240418 · JDI
Howmedica Osteonics Corp., Dba...
Orthopedic · 59d
Cleared Apr 12, 2024
Vantage Fortian/Orian 1.5T, MRT-1550, V9.0 with AiCE Reconstruction...
K240238 · LNH
Canon Medical Systems Corporation
Radiology · 74d
Cleared Apr 12, 2024
Medical electronic thermometer (FC01, FC02)
K240109 · FLL
Zhuzhou Goldenhot Medical Technology...
General Hospital · 87d
Cleared Apr 12, 2024
HCG One Step Pregnancy Test Strip OTC, HCG One Step Pregnancy Test Strip Rx,...
K233624 · LCX
Hangzhou Aichek Medical Technology...
Chemistry · 151d
Cleared Apr 12, 2024
Mobility+ Enteral Feeding System OTC
K233034 · PIF
Rockfield Medical
Gastroenterology & Urology · 200d
Cleared Apr 12, 2024
Duo Hands-free Breast Pump
K232608 · HGX
Medela, LLC
Obstetrics & Gynecology · 228d
Cleared Apr 12, 2024
MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay...
K232587 · MRG
Shenzhen New Industries Biomedical...
Chemistry · 231d
Cleared Apr 12, 2024
VenusX
K232489 · IYE
Linatech, LLC
Radiology · 239d
Cleared Apr 12, 2024
Disposable Injection Needles
K232200 · FBK
Ningbo Xinwell Medical Technology...
Gastroenterology & Urology · 262d
Cleared Apr 12, 2024
Access NT-proBNP
K232164 · NBC
Beckman Coulter, Inc.
Chemistry · 266d
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