Search FDA 510(k) Devices

5,501 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
2521–2544 of 174,061
Cleared Jun 12, 2025
Second Opinion® CS
K243234 · MYN
Pearl, Inc.
Radiology · 245d
Cleared Jun 12, 2025
iDart Lyme IgM ImmunoBlot Kit
K242872 · LSR
Id-Fish Technology, Inc.
Microbiology · 262d
Cleared Jun 12, 2025
Synicem Hip Spacer
K242865 · KWL
Biocomposites, Ltd.
Orthopedic · 265d
Cleared Jun 11, 2025
Frova Intubating Introducer (C-CAE-14.0-70-FII)
K251499 · BTR
William Cook Europe Aps
Anesthesiology · 27d
Cleared Jun 11, 2025
LORRAINE 2.5/3.5mm Distal Humerus System
K250933 · HRS
Bonebridge AG
Orthopedic · 75d
Cleared Jun 11, 2025
Liberant Thrombectomy System
K250787 · QEW
Medtronic, Ireland
Cardiovascular · 89d
Cleared Jun 11, 2025
Injectable Root Canal Bioceramic Sealer (nRoot SP)
K250710 · KIF
Enpuno Co., Ltd.
Dental · 93d
Cleared Jun 11, 2025
Impact PEEK Union Nail System
K250646 · HTY
Nvision Biomedical Technologies
Orthopedic · 99d
Cleared Jun 11, 2025
Rezum System
K250584 · KNS
Boston Scientific Corporation
Gastroenterology & Urology · 104d
Cleared Jun 11, 2025
Ambu® aScope™ 5 Cysto HD (Standard Deflection)
K250269 · FAJ
Ambu A/S
Gastroenterology & Urology · 132d
Cleared Jun 11, 2025
Self-Forming Magnet (Flexagon)
K243482 · SAH
GI Windows, Inc.
General & Plastic Surgery · 215d
Cleared Jun 11, 2025
MICOR 700 System (N/A)
K242801 · HQC
Carl Zeiss Meditec Cataract...
Ophthalmic · 267d
Cleared Jun 11, 2025
da Vinci X Surgical System (IS4200)
K240852 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 440d
Cleared Jun 10, 2025
Elecsys Anti-SARS-CoV-2
K250768 · QVP
Roche Diagnostics
Microbiology · 89d
Cleared Jun 10, 2025
Dental Barrier and Sleeves
K250735 · PEM
Fomed Industries, Inc.
Dental · 91d
Cleared Jun 10, 2025
Viz Subdural+, Viz SUBDURAL PLUS
K250354 · QIH
Viz. Ai, Inc.
Radiology · 123d
Cleared Jun 10, 2025
EXTRON 3
K250010 · OWB
DRTECH Corporation
Radiology · 159d
Cleared Jun 10, 2025
TG-980P CO2 Sensor Kit (TG-980P)
K243956 · CCK
Nihon Kohden Corporation
Anesthesiology · 169d
Cleared Jun 10, 2025
FUJIFILM Endoscope Model EG-840N
K243512 · FDS
Fujifilm Corporation
Gastroenterology & Urology · 210d
Cleared Jun 10, 2025
EndyMed PRO MAX
K242996 · GEI
Endymed Medical, Ltd.
General & Plastic Surgery · 257d
Cleared Jun 10, 2025
5300600-5301000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed,...
K242921 · BTO
Vitaltec Corporation
Anesthesiology · 259d
Cleared Jun 09, 2025
MallyaG Injection Pen Adapter (MallyaG)
K251500 · QOG
Biocorp Production
General Hospital · 25d
Cleared Jun 09, 2025
Bonvadis®
K251093 · FRO
Oneness Biotech Co., Ltd.
General & Plastic Surgery · 60d
Cleared Jun 09, 2025
LED Light Therapy Mask (G15, G15P, G15K, G11P, G11, G10, G13, G14, G17, VISO,...
K250830 · OHS
Shenzhen Sungrow Led Technology Co.,...
General & Plastic Surgery · 82d