Search FDA 510(k) Devices

5,391 clearances indexed · Search by device name, K-number, manufacturer or product code

Filters: 2025–2025 ×
3,225 results
313–336 of 3,225
Cleared Nov 25, 2025
IPL Hair Removal Device (KA-10, KA-11, KA-11C, KA-11D, KA-18, KA-20, KA-21,...
K253304 · OHT
Dongguan Lide Electric Appliance Co.,...
General & Plastic Surgery · 57d
Cleared Nov 25, 2025
LeafPure-Echo (LM-LPNdA)
K253219 · GEX
Shenzhen Leaflife Technology Co., Ltd.
General & Plastic Surgery · 57d
Cleared Nov 25, 2025
Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)
K252889 · KNS
Olympus Medical Systems Corporation
Gastroenterology & Urology · 76d
Cleared Nov 25, 2025
HALO AP Dx
K252762 · QKQ
Indica Labs, LLC
Pathology · 88d
Cleared Nov 25, 2025
ZSFab Lumbar Interbody System
K252610 · MAX
Zsfab, Inc.
Orthopedic · 99d
Cleared Nov 25, 2025
Medusa Orthopedics Boa External Fixation System
K252555 · KTT
Medusa Orthopedics, LLC
Orthopedic · 104d
Cleared Nov 25, 2025
Eva Scalp Cooling System
K252289 · PMC
Stemtech Medical Devices Private Limited
General & Plastic Surgery · 125d
Cleared Nov 25, 2025
Geistlich Mucograft® /Geistlich Mucograft® Seal
K252253 · NPL
Geistlich Pharma AG
Dental · 127d
Cleared Nov 25, 2025
Hushd Avera
K252161 · LRK
Good Sleep CO Pte , Ltd.
Dental · 138d
Cleared Nov 25, 2025
enCore Night Guard
K252004 · OBR
Encore Guards
Dental · 151d
Cleared Nov 25, 2025
Spectra Platinum
K251932 · HGX
Uzinmedicare Co., Ltd.
Obstetrics & Gynecology · 154d
Cleared Nov 25, 2025
RCT700
K251798 · OAS
Ray Co., Ltd.
Radiology · 166d
Cleared Nov 25, 2025
NX01 (NX01)
K251550 · OMC
Naox Technologies Sas
Neurology · 188d
Cleared Nov 25, 2025
PennPET Explorer Positron Emission Tomograph
K251401 · KPS
Trustees of the University of...
Radiology · 203d
Cleared Nov 25, 2025
Akura Thrombectomy System
K251070 · QEW
Akura Medical
Cardiovascular · 232d
Cleared Nov 25, 2025
Scaida BrainCT-ICH (v1.0)
K250694 · QAS
Mlhealth 360
Radiology · 263d
Cleared Nov 25, 2025
FEops HEARTguide Simulation Application
K250635 · QQI
Feops NV
Cardiovascular · 267d
Cleared Nov 24, 2025
NeVa PV Thrombectomy Device
K253407 · QEX
Vesalio, Inc.
Cardiovascular · 55d
Cleared Nov 24, 2025
Thulium Fiber Laser System (TFL-A)
K252787 · GEX
Guangzhou Potent Medical Equipment...
General & Plastic Surgery · 83d
Cleared Nov 24, 2025
Holmium Laser System (Potent HP90)
K252771 · GEX
Guangzhou Potent Medical Equipment...
General & Plastic Surgery · 83d
Cleared Nov 24, 2025
F Care RF System (00MEDRF4000US, 05RAFAELOPROBE, 05SPHERAPROBE, 06OUTPUTKAB,...
K252704 · GEI
F Care Systems USA, LLC
General & Plastic Surgery · 89d
Cleared Nov 24, 2025
Transcutaneous Electrical Nerve Stimulator (RJTENS-2)
K252688 · NUH
Bozhou Rongjian Medical Appliance...
Neurology · 90d
Cleared Nov 24, 2025
AlphaVac Multipurpose Mechanical Aspiration System F1885
K252509 · QEZ
AngioDynamics, Inc.
Cardiovascular · 108d
Cleared Nov 24, 2025
a2z-Unified-Triage
K252366 · QAS
A2z Radiology Ai, Inc.
Radiology · 117d