Search FDA 510(k) Devices

5,377 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
457–480 of 174,061
Cleared Feb 06, 2026
Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro)
K253221 · IYO
Eieling Technology (Shenzhen) Limited
Radiology · 130d
Cleared Feb 06, 2026
Q Interbody Instruments
K252873 · OLO
K2m, Inc.
Orthopedic · 149d
Cleared Feb 06, 2026
Spine Guidance 5.3 Software
K252871 · OLO
Stryker Leibinger GmbH & Co KG
Orthopedic · 149d
Cleared Feb 06, 2026
IntelliVue Multi-Measurement Module X3 (867030)
K252726 · MHX
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 162d
Cleared Feb 06, 2026
Kneevoice Cartilage Evaluation System (750-3600-001)
K252076 · DQD
Kneevoice, Inc.
Cardiovascular · 219d
Cleared Feb 06, 2026
ROSA Knee System with UltraSound Imaging Platform (USIP)
K252058 · OLO
Balmoral Medical, LLC
Orthopedic · 220d
Cleared Feb 06, 2026
Dermatrix Duo
K251836 · GEI
Shenzhen Gsd Technology Co., Ltd.
General & Plastic Surgery · 235d
Cleared Feb 06, 2026
Stainless Steel Surgical Kits
K251614 · KCT
Dentsply Sirona, Inc.
General Hospital · 255d
Cleared Feb 06, 2026
LAIA XR
K251577 · LLZ
Augmented Reality Software S.L.
Radiology · 260d
Cleared Feb 06, 2026
Atellica® IM TSH3-Ultra II (TSH3ULII)
K251543 · JLW
Siemens Healthcare Diagnostics, Inc.
Chemistry · 262d
Cleared Feb 06, 2026
INTEGRE LIO
K251507 · HQF
Quantel Medical
Ophthalmic · 266d
Cleared Feb 06, 2026
Median LCS (internal name) / eyonis LCS (trade name) (1.0)
K251474 · QDQ
Median Technologies
Radiology · 269d
Cleared Feb 06, 2026
Spectra S1 Pro
K251423 · HGX
Uzinmedicare Co., Ltd.
Obstetrics & Gynecology · 274d
Cleared Feb 06, 2026
SafeBeat Rx App
K251218 · DQK
Safebeat Rx, Inc.
Cardiovascular · 291d
Cleared Feb 06, 2026
Aptiva APS IgA Reagent
K243979 · MSV
Inova Diagnostics, Inc.
Immunology · 410d
Cleared Feb 06, 2026
Athelas Home
K243348 · GKZ
Athelas, Inc.
Hematology · 466d
Cleared Feb 05, 2026
CLEANER™ Vac Thrombectomy System, CLEANER™ Vac Aspiration Catheter with...
K260028 · QEW
Argon Medical Devices, Inc.
Cardiovascular · 31d
Cleared Feb 05, 2026
Primevision 3D
K253959 · OAS
Dentsply Sirona
Radiology · 57d
Cleared Feb 05, 2026
SIGNA™ Sprint Select
K253779 · LNH
Ge Medical Systems, LLC
Radiology · 71d
Cleared Feb 05, 2026
INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK
K251949 · QEW
Penumbra, Inc.
Cardiovascular · 225d
Cleared Feb 05, 2026
Encora X1
K251517 · QBC
Encora, Inc.
Neurology · 265d
Cleared Feb 04, 2026
Signature™ ONE System
K260104 · QHE
Orthosoft Inc. (d/b/a) Zimmer CAS
Orthopedic · 22d
Cleared Feb 04, 2026
E3D™-C Interbody System
K260038 · OVE
Evolution Spine
Orthopedic · 29d
Cleared Feb 04, 2026
UltraScore™ Focused Force PTA Balloon
K260012 · PNO
Bard Peripheral Vascular, Inc.
Cardiovascular · 30d