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"
25–48 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jun 15, 2026
Saige-Dx
K253825 · QDQ
DeepHealth, Inc.
Radiology · 196d
Cleared Jun 15, 2026
LungMaps
K253690 · QIH
Siemens Healthineers AG
Radiology · 206d
Cleared Jun 12, 2026
Profoject™ Safety Needle
K260514 · FMF
CMT Health PTE., Ltd.
General Hospital · 115d
Cleared Jun 12, 2026
Universal 1417PI
K252996 · MQB
Konica Minolta Healthcare Americas, Inc.
Radiology · 267d
Cleared Jun 10, 2026
Profoject™ Safety Pen Needles
K260855 · FMI
CMT Health PTE., Ltd.
General Hospital · 86d
Cleared Jun 04, 2026
Dental Cone Beam Computed Tomography System
K260662 · OAS
Yofo Medical Technology Co., Ltd.
Radiology · 94d
Cleared Jun 04, 2026
Harmony Referral System with Harmony OCT Viewer (Octave)
K253893 · NFJ
Topcon Healthcare Solutions EMEA Oy
Ophthalmic · 182d
Cleared Jun 03, 2026
VITA Multi-Function Head Brush (TB-2343F, TB-2442F)
K260179 · NFO
Touchbeauty Beauty & Health...
Neurology · 133d
Cleared May 27, 2026
Helion Viewer Suite
K254265 · LLZ
Videomed Srl ( a Baxter Healthcare...
Radiology · 148d
Cleared May 27, 2026
Synapse Lung Nodule AI
K254075 · OEB
Fujifilm Corporation
Radiology · 160d
Cleared May 26, 2026
4K NIR/ICG Imaging System
K260318 · GCJ
Zhejiang Healnoc Technology Co., Ltd.
General & Plastic Surgery · 116d
Cleared May 22, 2026
uMR Astra
K260113 · LNH
Shanghai United Imaging Healthcare...
Radiology · 128d
Cleared May 22, 2026
Spectrum-2
K254129 · MUD
Neko Health AB
General & Plastic Surgery · 151d
Cleared May 22, 2026
AiSteth®
K252915 · DQD
Ai Health Highway India Pvt., Ltd.
Cardiovascular · 252d
Cleared May 21, 2026
BAC
K254131 · QIH
DeepHealth, Inc.
Radiology · 150d
Cleared May 21, 2026
uSONIQUE Nova, uSONIQUE Nova Elite, uSONIQUE Vita, uSONIQUE Vita Elite,...
K253720 · IYN
Wuhan United Imaging Healthcare Co.,Ltd
Radiology · 178d
Cleared May 20, 2026
The Circadia C300 System (C300)
K261286 · DRT
Circadia Health, Inc.
Cardiovascular · 30d
Cleared May 20, 2026
Derma-2
K253911 · LHQ
Neko Health AB
Radiology · 163d
Cleared May 15, 2026
uSONIQUE Genesis, uSONIQUE Genesis Pro, uSONIQUE Genesis Elite, uSONIQUE...
K253716 · IYN
Wuhan United Imaging Healthcare Co.,Ltd
Radiology · 172d
Cleared May 13, 2026
Morph
K260032 · QIH
BeauBrain Healthcare, Inc.
Radiology · 127d
Cleared Apr 30, 2026
Bayesian Health Sepsis Flagging Device
K250680 · SAK
Bayesian Health, Inc.
Gastroenterology & Urology · 420d
Cleared Apr 29, 2026
DeepHealth ProstateAI
K253682 · QDQ
Quantib B.V.
Radiology · 159d
Cleared Apr 29, 2026
Paptizer 360
K252471 · QXQ
LiViliti Health Products Corporation
General Hospital · 266d
Cleared Apr 28, 2026
Cardinal Health™ Poly Reinforced Surgical Gown
K253243 · FYA
Cardinal Health 200, LLC
General Hospital · 211d