FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

5,198 results for "health"
73–96 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Mar 06, 2026
Bunkerhill Contrast CAC
K260166 · JAK
BunkerHill Health
Radiology · 45d
Cleared Mar 02, 2026
Disposable Microwave Ablation Antenna (DW-XR-II1, DW-XR-II3, DW-XR-II4,...
K253771 · NEY
Nanjing Devin Medical Technology Co.,...
General & Plastic Surgery · 96d
Cleared Mar 02, 2026
Clarius Ejection Fraction AI
K253593 · QIH
Clarius Mobile Health Corp.
Radiology · 105d
Cleared Mar 02, 2026
Microwave Ablation Device
K252632 · NEY
Nanjing Dewen Medical Technology Co.,...
General & Plastic Surgery · 194d
Cleared Feb 27, 2026
Atellica CH Diazo Total Bilirubin (D_TBil)
K251998 · CIG
Siemens Healthcare Diagnostics, Inc.
Chemistry · 245d
Cleared Feb 26, 2026
ANNE Maternal
K253021 · HGM
Sibel Health, Inc.
Obstetrics & Gynecology · 160d
Cleared Feb 23, 2026
Profoject™ Insulin Syringes
K253068 · FMF
CMT Health PTE., Ltd.
General Hospital · 154d
Cleared Feb 19, 2026
Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe
K252814 · QNQ
CMT Health PTE., Ltd.
General Hospital · 168d
Cleared Feb 17, 2026
FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display Unit
K250550 · FDS
Fujifilm Corporation
Gastroenterology & Urology · 357d
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