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"
193–216 of 5,274
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Sep 19, 2025
uDR Aurora CX
K251167 · KPR
Shanghai United Imaging Healthcare...
Radiology · 157d
Cleared Sep 19, 2025
Videa Dental AI
K251002 · MYN
Videahealth, Inc.
Radiology · 171d
Cleared Sep 19, 2025
Sonicaid Team3
K250777 · HGM
Huntleigh Healthcare , Ltd.
Obstetrics & Gynecology · 189d
Cleared Sep 19, 2025
Bunkerhill ECG-EF
K250649 · QYE
BunkerHill Health
Cardiovascular · 199d
Cleared Sep 17, 2025
Air Compression Therapy Device (K1002/K1006/K1007/K1008/K1061)
K251623 · IRP
Shenzhen Yicai Health Technology Co.,...
Physical Medicine · 112d
Cleared Sep 17, 2025
ECHELON Synergy
K251386 · LNH
Fujifilm Corporation
Radiology · 135d
Cleared Sep 15, 2025
InferOperate Suite
K250237 · QIH
Beijing Infervision Healthcare...
Radiology · 231d
Cleared Sep 12, 2025
uWS-Angio
K250040 · LLZ
Shanghai United Imaging Healthcare...
Radiology · 247d
Cleared Sep 11, 2025
Vivatmo pro-S
K243926 · MXA
Bosch Healthcare Solutions GmbH
Chemistry · 265d
Cleared Sep 10, 2025
F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb...
K252173 · CBK
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 61d
Cleared Sep 09, 2025
AI-Rad Companion Prostate MR
K252608 · LLZ
Siemens Healthcare GmbH
Radiology · 22d
Cleared Sep 09, 2025
Electric Wheelchair (GY-E001)
K251891 · ITI
Shandong Guyue Healthcare Appliance...
Physical Medicine · 81d
Cleared Sep 04, 2025
Image Suite
K251168 · LLZ
Carestream Health, Inc.
Radiology · 142d
Cleared Aug 29, 2025
GLAM LED Facial Mask (TB-2386F)
K251727 · GEX
Touchbeauty Beauty & Health...
General & Plastic Surgery · 85d
Cleared Aug 27, 2025
Vital Signs
K243687 · QME
Oxehealth Limited
Cardiovascular · 271d
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