FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

5,274 results for "health"
121–144 of 5,274
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Feb 13, 2026
uMI Panvivo (uMI Panvivo)
K253564 · KPS
Shanghai United Imaging Healthcare...
Radiology · 88d
Cleared Feb 13, 2026
Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-61D2L,...
K252685 · DXN
Joytech Healthcare Co. , Ltd.
Cardiovascular · 171d
Cleared Feb 12, 2026
Well-Life Incontinence Stimulation System (WL-2405i(P))
K251760 · KPI
Well-Life Healthcare , Ltd.
Gastroenterology & Urology · 248d
Cleared Feb 06, 2026
Hood DH-084STR
K253568 · FDS
Fujifilm Corporation
Gastroenterology & Urology · 81d
Cleared Feb 06, 2026
Atellica® IM TSH3-Ultra II (TSH3ULII)
K251543 · JLW
Siemens Healthcare Diagnostics, Inc.
Chemistry · 262d
Cleared Feb 03, 2026
The Circadia C300 System (C300)
K252676 · DRT
Circadia Health, Inc.
Cardiovascular · 162d
Cleared Feb 02, 2026
Vital Signs
K251200 · QME
Oxehealth Limited
Cardiovascular · 290d
Cleared Jan 29, 2026
EZ-Protect Hydrophilic Closed System Intermittent Catheter
K251274 · EZD
HR Healthcare
Gastroenterology & Urology · 280d
Cleared Jan 23, 2026
3.0T AIR 32CH HNA
K253738 · MOS
Ge Healthcare Coils (Usa Instruments,...
Radiology · 60d
Cleared Jan 22, 2026
AI-Rad Companion Brain MR
K253057 · QIH
Siemens Healthcare GmbH
Radiology · 122d
Cleared Jan 22, 2026
Perin Health System (PHD80060-2)
K252984 · DRG
Perin Health Devices, LLC
Cardiovascular · 126d
Cleared Jan 20, 2026
uCT 780 with uWS-CT-Dual Energy Analysis
K253173 · JAK
Shanghai United Imaging Healthcare...
Radiology · 116d
Cleared Jan 20, 2026
DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35...
K250954 · KPR
Carestream Health
Radiology · 298d
Cleared Jan 16, 2026
VITAL Tubing Sets for Hemodialysis
K251341 · FJK
Vital Healthcare Sdn. Bhd.
Gastroenterology & Urology · 261d
Cleared Jan 16, 2026
WAVE Clinical Platform (2.0.000)
K250135 · MWI
Baxter Healthcare Corp/ Excel Medical
Cardiovascular · 364d
Not Cleared Jan 16, 2026
Sana Device
DEN250005 · QYN
Sana Health
Neurology · 319d
Cleared Jan 15, 2026
BIOGRAPH One
K253023 · OUO
Siemens Healthineers AG
Radiology · 118d
Cleared Jan 14, 2026
Cardinal Health Nitrile Examination Gloves Extended Cuff
K252313 · LZC
Cardinalhealth
General Hospital · 173d
Cleared Jan 12, 2026
Dr. Yglo Skin Tag Remover
K251524 · GEH
Theotclab Healthcare B.V.
General & Plastic Surgery · 241d
Cleared Jan 09, 2026
Core Metabolic
K251157 · CIX
Truvian Health
Chemistry · 269d
Cleared Jan 08, 2026
3DICOM MD Cloud
K253784 · LLZ
Singular Health Pty, Ltd.
Radiology · 43d
Cleared Jan 08, 2026
View
K253639 · LLZ
Ge Healthcare
Radiology · 50d
Cleared Jan 07, 2026
Reprocessed Agilis NxT Steerable Introducer
K250305 · PNE
Innovative Health
Cardiovascular · 338d
Cleared Jan 05, 2026
Atellica IM Total PSA II (tPSAII)
K251630 · LTJ
Siemens Healthcare Diagnostics, Inc.
Immunology · 222d