Search FDA 510(k) Devices

5,531 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
3025–3048 of 174,061
Cleared Apr 18, 2025
SofWave System
K250146 · NGX
Sofwave Medical, Ltd.
Neurology · 87d
Cleared Apr 18, 2025
Wireless/ Wired X-Ray Flat Panel Detectors
K243734 · MQB
Allengers Medical Systems Limited
Radiology · 135d
Cleared Apr 18, 2025
LIAISON PLEX Gram-Negative Blood Culture Assay
K243013 · PEN
Luminex Corporation
Microbiology · 203d
Cleared Apr 18, 2025
K-ASSAY CRP (Ver.2)
K242170 · DCK
Kamiya Biomedical Company, LLC
Immunology · 268d
Cleared Apr 18, 2025
ULTRA 1040
K241996 · IZL
Ecoray Co., Ltd.
Radiology · 283d
Cleared Apr 18, 2025
Acucy® Influenza A&B Test with the Acucy® 2 System
K241188 · PSZ
SEKISUI Diagnostics, LLC
Microbiology · 354d
Cleared Apr 18, 2025
PeriBeam® Pericardial Membrane
K240775 · DXZ
Tamabio
Cardiovascular · 393d
Cleared Apr 18, 2025
FROG (Filter Removal of Glass)
K240355 · FMI
Carrtech Corp
General Hospital · 438d
Cleared Apr 17, 2025
EXULT Knee Replacement System
K250889 · JWH
Corentec Co., Ltd.
Orthopedic · 23d
Cleared Apr 17, 2025
Lacevo Wearable Breast Pump (Model S70)
K250829 · HGX
Shenzhen TPH Technology Co., Ltd.
Obstetrics & Gynecology · 29d
Cleared Apr 17, 2025
RELiZORB (100300/100301)
K250499 · PLQ
Alcresta Therapeutics, Inc.
Gastroenterology & Urology · 56d
Cleared Apr 17, 2025
FLUOBEAM LX Imaging System (FBLX)
K250455 · QDG
Fluoptics Sas (A Getinge Group Company)
General & Plastic Surgery · 58d
Cleared Apr 17, 2025
Luja Set
K250270 · EZD
Coloplast Corp.
Gastroenterology & Urology · 77d
Cleared Apr 17, 2025
CLARUS (700)
K243878 · QER
Carl Zeiss Meditec, Inc.
Ophthalmic · 120d
Cleared Apr 17, 2025
SimpleStitch Suturing System
K243750 · OCW
Envision Endoscopy
Gastroenterology & Urology · 133d
Cleared Apr 17, 2025
Ultimate rTMS
K243460 · OBP
Brain Ultimate, Inc.
Neurology · 160d
Cleared Apr 17, 2025
Ultimate rTMS for OCD (M-series)
K243459 · QCI
Brain Ultimate, Inc.
Neurology · 160d
Cleared Apr 17, 2025
Dental Cone Beam Computed Tomography System
K243337 · OAS
Yofo Medical Technology Co., Ltd.
Radiology · 174d
Cleared Apr 17, 2025
RayCare (2024A SP1)
K242992 · MUJ
RaySearch Laboratories AB (PUBL)
Radiology · 203d
Cleared Apr 17, 2025
FlowGuide (FG60F)
K242337 · DQY
Imds Operations B.V.
Cardiovascular · 253d
Cleared Apr 17, 2025
VitalRhythm
K242129 · DQK
Vitalconnect, Inc.
Cardiovascular · 269d
Cleared Apr 17, 2025
miacare (DELiGHT daily wear/ DELiGHT 1-day/ CONFiDENCE Color daily...
K242056 · LPL
Benq Materials Corporation
Ophthalmic · 276d
Cleared Apr 16, 2025
Nanox.ARC X
K250850 · IZF
Nano-X Imaging , Ltd.
Radiology · 27d
Cleared Apr 16, 2025
Stellar M22
K250809 · GEX
Lumenis Be, Ltd.
General & Plastic Surgery · 30d