Search FDA 510(k) Devices

5,517 clearances indexed · Search by device name, K-number, manufacturer or product code

Filters: 2025–2025 ×
3,225 results
2401–2424 of 3,225
Cleared Apr 09, 2025
FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)
K243966 · BZQ
Faceheart Corp.
Anesthesiology · 107d
Cleared Apr 09, 2025
Luminopia
K243819 · QQU
Luminopia, Inc.
Ophthalmic · 118d
Cleared Apr 09, 2025
autoSCORE (V 2.0.0)
K243743 · OMB
Holberg Eeg AS
Neurology · 126d
Cleared Apr 09, 2025
Patch-TEA (Model TRI-21)
K243613 · NUH
Transtimulation Research, Inc.
Neurology · 138d
Cleared Apr 09, 2025
Dexcom G7 15 Day Continuous Glucose Monitoring System
K243214 · QBJ
Dexcom, Inc.
Chemistry · 188d
Cleared Apr 09, 2025
CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion...
K242429 · SEF
Becton Dickinson Inc. (Bd)
General Hospital · 237d
Cleared Apr 09, 2025
Ceribell Seizure Detection Software
K241589 · OMB
Ceribell, Inc.
Neurology · 310d
Not Cleared Apr 09, 2025
Tango® Belt (Model SAS-001-01 (XS)
DEN240021 · SEC
Active Protective Technologies, Inc.
Physical Medicine · 328d
Cleared Apr 08, 2025
TriMed Fusion Cup System
K250948 · HRS
TriMed, Inc.
Orthopedic · 18d
Cleared Apr 08, 2025
NPseal
K250708 · OKO
Guard Medical, Inc.
General & Plastic Surgery · 29d
Cleared Apr 08, 2025
Electric Wheelchair (LW01301A07)
K250366 · ITI
Anhui Longway Medical Technology Co.,...
Physical Medicine · 57d
Cleared Apr 08, 2025
LuxCreo Clear Aligner System
K250343 · NXC
LuxCreo, Inc.
Dental · 61d
Cleared Apr 08, 2025
Globalcare Blood Pressure Monitor (GUS610)
K250136 · DXN
Globalcare Medical Technology Co., Ltd.
Cardiovascular · 81d
Cleared Apr 08, 2025
ONE Nitrile Condom
K243967 · MOL
Global Protection Corp.
Obstetrics & Gynecology · 106d
Cleared Apr 08, 2025
Jmoon Conductive Gel
K243749 · GYB
Shenzhen Ulike Smart Electronics Co.,...
Neurology · 124d
Cleared Apr 08, 2025
Pre-B Seal Lung Biopsy Plug System - 15cm Model (FG0001)
K243722 · OMT
Selio Medical Limited
Anesthesiology · 126d
Cleared Apr 08, 2025
Disposable Aqueous Humor Collector (SnovoDAHC I-50, SnovoDAHC II-50,...
K243027 · QLY
Hangzhou Sightnovo Medical Technology...
General Hospital · 193d
Cleared Apr 08, 2025
Horos Mobile
K242552 · LLZ
Icat Solutions, Ltd.
Radiology · 224d
Cleared Apr 08, 2025
BunkerHill BMD
K242295 · KGI
BunkerHill Health
Radiology · 249d
Cleared Apr 08, 2025
Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, HD-69, HD-69A,...
K242151 · OHS
Shenzhen Nuon Medical Equipment Co.,...
General & Plastic Surgery · 259d
Cleared Apr 07, 2025
NanoBone® SBX Putty
K250521 · MQV
Biocomposites, Ltd.
Orthopedic · 45d
Cleared Apr 07, 2025
Ultraviolet Phototherapy Device
K250425 · FTC
APK Technology Co., Ltd.
General & Plastic Surgery · 52d
Cleared Apr 07, 2025
BioBrace ® RC Delivery System
K250395 · ORQ
Conmed Corporation
Orthopedic · 54d
Cleared Apr 07, 2025
Smart Pulse Relief (PZ-2622, PZ-2622T, PZ-2622E)
K250033 · NUH
Guangzhou Pinzhi Medical Technology...
Neurology · 90d