Search FDA 510(k) Devices

5,400 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
817–840 of 174,061
Cleared Dec 19, 2025
IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)
K253577 · MAX
Medicrea International S.A.S....
Orthopedic · 32d
Cleared Dec 19, 2025
Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)
K253479 · BTT
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 66d
Cleared Dec 19, 2025
C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48),...
K253409 · DQY
Medtronic, Inc.
Cardiovascular · 80d
Cleared Dec 19, 2025
Southern Craniomaxillofacial (CMF) System
K253373 · JEY
Southern Medical (Pty) , Ltd.
Dental · 80d
Cleared Dec 19, 2025
Diazyme Human Kappa (k) Free Light Chain Assay
K253358 · DFH
Diazyme Laboratories, Inc.
Immunology · 80d
Cleared Dec 19, 2025
Hoffmann LRF System
K253202 · KTT
Stryker GmbH
Orthopedic · 84d
Cleared Dec 19, 2025
Balanced Knee System TriMax Porous Femoral Components
K253161 · MBH
Ortho Development Corp.
Orthopedic · 84d
Cleared Dec 19, 2025
LED Light Therapy Device (Models: SG-FM, SG-FE)
K253086 · OHS
Sunglor Technology Co., Ltd.
General & Plastic Surgery · 87d
Cleared Dec 19, 2025
LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)
K253054 · OHS
Shenzhen Xinlong Precision Plastic...
General & Plastic Surgery · 88d
Cleared Dec 19, 2025
EMPOWR Knee
K252974 · JWH
Encore Medical, L.P.
Orthopedic · 93d
Cleared Dec 19, 2025
SCOUT MD Surgical Guidance System
K252892 · NEU
Merit Medical Systems, Inc.
General & Plastic Surgery · 99d
Cleared Dec 19, 2025
SANDRO Dual
K252877 · GEX
Wontech Co., Ltd.
General & Plastic Surgery · 100d
Cleared Dec 19, 2025
ClearCalc Model RADCA V2.6
K252863 · MUJ
Radformation, Inc.
Radiology · 101d
Cleared Dec 19, 2025
MAGNETOM Sola
K252838 · LNH
Siemens Healthcare GmbH
Radiology · 105d
Cleared Dec 19, 2025
MSFX MIKRON PEEK CAGES
K252781 · ODP
Mikron Makina Sanayi VE Tic. Ltd. Sti.
Orthopedic · 108d
Cleared Dec 19, 2025
LCD Monitor (CL1902A, CL2103F)
K252780 · PGY
Shenzhen Beacon Display Technology...
Radiology · 108d
Cleared Dec 19, 2025
Wearable Electric Breast Pump (YM-8803)
K252754 · HGX
Guangdong Youmeng Electrical...
Obstetrics & Gynecology · 112d
Cleared Dec 19, 2025
Alzevita
K252670 · QIH
TOPIA MEDTECH LIMITED
Radiology · 116d
Cleared Dec 19, 2025
CE Deliver (DLV)
K252480 · NEZ
CapsoVision, Inc.
Gastroenterology & Urology · 134d
Cleared Dec 19, 2025
Electric Breast Pump (YM-8807, YM-8805, YM-8806, YM-8810)
K252342 · HGX
Guangdong Youmeng Electrical...
Obstetrics & Gynecology · 144d
Cleared Dec 19, 2025
eMurmur Heart AI
K252284 · DQD
Csd Labs
Cardiovascular · 150d
Cleared Dec 19, 2025
Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling...
K252167 · FRO
Qingdao Bright Moon Biomedical...
General & Plastic Surgery · 162d
Cleared Dec 19, 2025
AI-CVD
K252029 · QIH
HeartLung Corporation
Radiology · 172d
Cleared Dec 19, 2025
Spo2 Sensor CSS032D
K251751 · DQA
Shenzhen Ykd Technology Co., Ltd.
Anesthesiology · 193d