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"
169–192 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Aug 22, 2025
Monoject™ 1mL Tuberculin Syringe Luer-Lock Tip (1180100777)
K243660 · FMF
Cardinalhealth
General Hospital · 268d
Cleared Aug 21, 2025
LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910)
K251588 · OHS
Shenzhen Fittop Health Technology...
General & Plastic Surgery · 90d
Cleared Aug 21, 2025
Transcutaneous Electrical Nerve Stimulator ( K6133/ K6134/ K6135/ K6136/...
K250784 · NUH
Shenzhen Yicai Health Technology Co.,...
Neurology · 160d
Cleared Aug 14, 2025
3nethra neo HD FA
K243600 · HKI
Forus Health Pvt.Ltd
Ophthalmic · 266d
Cleared Aug 12, 2025
Eko Foundation Analysis Software with Transformers (EFAST)
K251494 · DQD
Eko Health, Inc.
Cardiovascular · 89d
Cleared Aug 11, 2025
Saige-Dx
K251873 · QDQ
DeepHealth, Inc.
Radiology · 54d
Cleared Aug 08, 2025
Coretech Compression System (Coretech RHB3003)
K250817 · JOW
Vive Health, LLC
Cardiovascular · 143d
Cleared Aug 05, 2025
Chemfort Female Luer Lock Adaptor
K251411 · ONB
Simplivia Healthcare , Ltd.
General Hospital · 90d
Cleared Aug 05, 2025
uMR Jupiter
K250246 · LNH
Shanghai United Imaging Healthcare...
Radiology · 190d
Cleared Aug 05, 2025
iPETcertum (v1.0)
K244016 · LLZ
Claritas Healthtech Pte, Ltd.
Radiology · 221d
Cleared Aug 04, 2025
iHealth Compare Wireless Blood Pressure Monitor(BP-300C)
K251113 · DXN
Andon Health Co, Ltd.
Cardiovascular · 115d
Cleared Aug 01, 2025
AK 98 Dialysis Machine (955607)
K250508 · KDI
Vantive US Healthcare, LLC
Gastroenterology & Urology · 161d
Cleared Jul 29, 2025
PRORAD ATLAS ULTRAPORTABLE
K243473 · IZL
Prognosys Medical Systems Private...
Radiology · 263d
Cleared Jul 28, 2025
SIGMA Spectrum Infusion Pump with Master Drug Library
K251640 · FRN
Baxter Healthcare Corporation
General Hospital · 60d
Cleared Jul 28, 2025
Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)
K251636 · FRN
Baxter Healthcare Corporation
General Hospital · 60d
Cleared Jul 25, 2025
Profoject™ Disposable Syringe, Profoject™ Disposable Syringe with Needle
K252033 · FMF
CMT Health PTE., Ltd.
General Hospital · 25d
Cleared Jul 22, 2025
Granudacyn® Wound Irrigation Solution
K243415 · FRO
P.G.F. Industry Solutions GmbH
General & Plastic Surgery · 263d
Cleared Jul 18, 2025
Profoject™ Enteral Feeding Syringe
K251585 · PNR
CMT Health PTE., Ltd.
Gastroenterology & Urology · 56d
Cleared Jul 17, 2025
uMI Panvivo (uMI Panvivo)
K251839 · KPS
Shanghai United Imaging Healthcare...
Radiology · 31d
Cleared Jul 17, 2025
uMR Ultra
K243547 · LNH
Shanghai United Imaging Healthcare...
Radiology · 244d
Cleared Jul 16, 2025
uMR 680
K243397 · LNH
Shanghai United Imaging Healthcare...
Radiology · 258d
Cleared Jul 14, 2025
PeekMed web
K251096 · QIH
Peek Health, S.A.
Radiology · 95d
Cleared Jul 14, 2025
F&P Optiflow Air/Oxygen Flow Source
K243917 · BZR
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 206d
Cleared Jul 09, 2025
EZ-FIDUCIALS
K250505 · HAW
Phasor Health, LLC
Neurology · 138d