Search FDA 510(k) Devices

5,404 clearances indexed · Search by device name, K-number, manufacturer or product code

Filters: 2025–2025 ×
3,225 results
553–576 of 3,225
Cleared Oct 28, 2025
Fine Osteotomy™
K253300 · HRS
Bodycad Laboratories, Inc.
Orthopedic · 29d
Cleared Oct 28, 2025
Navigated Instruments
K252742 · OLO
Tyber Medical, LLC
Orthopedic · 61d
Cleared Oct 28, 2025
TheraSphere 360™ Y-90 Management Platform
K252547 · LLZ
Boston Scientific Corporation
Radiology · 77d
Cleared Oct 28, 2025
Yomi S Robotic System
K252376 · PLV
Neocis, Inc.
Dental · 90d
Cleared Oct 28, 2025
UniSpace® TPLIF Cage
K252351 · MAX
Cg Medtech Co., Ltd.
Orthopedic · 91d
Cleared Oct 28, 2025
ZIRCONOMER P
K252165 · EMA
Shofu Dental Corporation
Dental · 110d
Cleared Oct 28, 2025
VenAir, Sequential Compression System (9P-089000)
K251466 · JOW
Wellell, Inc.
Cardiovascular · 168d
Cleared Oct 28, 2025
PrecisePath™ Radiofrequency Puncture Generator and PrecisePath™ Footswitch
K250275 · GEI
Baylis Medical Technologies, Inc.
General & Plastic Surgery · 270d
Cleared Oct 27, 2025
Electric Breast Pump (HL-3060, F5113)
K252630 · HGX
Fimilla (Shanghai) Maternity & Baby...
Obstetrics & Gynecology · 68d
Cleared Oct 27, 2025
Electric Breast Pump (HL-3058, F5112)
K252629 · HGX
Fimilla (Shanghai) Maternity & Baby...
Obstetrics & Gynecology · 68d
Cleared Oct 27, 2025
Disposable Vinyl Examination Gloves
K252467 · LYZ
Viet Phu Trade and Import Export Co.,...
General Hospital · 82d
Cleared Oct 27, 2025
VITA Multi-Function Head Brush (TB-2443F, TB-2442AF, TB-2343F, TB-2442F)
K252053 · OHS
Touchbeauty Beauty & Health...
General & Plastic Surgery · 118d
Cleared Oct 27, 2025
LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system
K251875 · SAN
Affinity Biosensors, LLC
Microbiology · 131d
Cleared Oct 27, 2025
Patriot Duo
K251824 · GEX
Patriot Laser, LLC
General & Plastic Surgery · 136d
Cleared Oct 27, 2025
Blood Pressure Monitor (B73, BE23T)
K251331 · DXN
Shenzhen Jamr Technology Co., Ltd.
Cardiovascular · 180d
Cleared Oct 27, 2025
cvi42 Coronary Plaque Software Application
K251027 · QIH
Circle Cardiovascular Imaging, Inc.
Radiology · 208d
Cleared Oct 27, 2025
OsteoCentric Navigated Instruments System
K250520 · OLO
Osteocentric Technologies, Inc.
Orthopedic · 248d
Cleared Oct 27, 2025
TECHFIT Patient-Specific Cranial System
K250297 · GWO
Techfit Digital Surgery, Inc.
Neurology · 269d
Cleared Oct 24, 2025
Expandable Titanium PLIF/TLIF System
K253377 · MAX
Spectrum Spine, Inc.
Orthopedic · 24d
Cleared Oct 24, 2025
CD Horizon™ Spinal System
K253335 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 24d
Cleared Oct 24, 2025
CoaguChek XS Plus System
K253188 · GJS
Roche Diagnostics
Hematology · 28d
Cleared Oct 24, 2025
Cryon-X Cold Compression
K253150 · IRP
Jkh Health Co., Ltd.
Physical Medicine · 29d
Cleared Oct 24, 2025
Infinity™ OCT System
K253129 · NKG
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 29d
Cleared Oct 24, 2025
Parietene™ Flat Sheet Mesh
K253125 · FTL
Medtronic - Sofradim Production
General & Plastic Surgery · 29d