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"
145–168 of 5,274
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Dec 30, 2025
Lipids
K251091 · CHH
Truvian Health
Chemistry · 264d
Cleared Dec 23, 2025
Philips Lumea IPL
K253754 · OHT
Philips Consumer Lifestyle B.V.
General & Plastic Surgery · 28d
Cleared Dec 22, 2025
SKOUT system
K253664 · QNP
Iterative Health
Gastroenterology & Urology · 32d
Cleared Dec 22, 2025
PeekMed web
K252856 · QIH
Peek Health, S.A.
Radiology · 104d
Cleared Dec 19, 2025
Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)
K253479 · BTT
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 66d
Cleared Dec 19, 2025
MAGNETOM Sola
K252838 · LNH
Siemens Healthcare GmbH
Radiology · 105d
Cleared Dec 19, 2025
Tru Liver Health Test Panel
K251074 · CJE
Truvian Health
Chemistry · 255d
Cleared Dec 16, 2025
Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)
K251745 · DXQ
Baxter Healthcare Corporation
Cardiovascular · 193d
Cleared Dec 12, 2025
iHealth Flu A&B/COVID-19 Rapid Test
K251092 · SCA
Ihealth Labs, Inc.
Microbiology · 246d
Cleared Dec 12, 2025
iHealth Flu A&B/COVID-19/RSV Rapid Test
K251085 · SCA
Ihealth Labs, Inc.
Microbiology · 247d
Cleared Dec 12, 2025
FUJIFILM Ultrasonic Endoscope EB-710US
K250863 · EOQ
Fujifilm Corporation
Ear, Nose, Throat · 266d
Cleared Dec 09, 2025
DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW)
K250805 · CAW
Devilbiss Healthcare, LLC
Anesthesiology · 267d
Cleared Dec 09, 2025
INFINITT DPS
K243449 · QKQ
Infinitt Healthcare Co., Ltd.
Pathology · 397d
Cleared Dec 04, 2025
ADVIA Centaur Anti-Thyroglobulin II (aTgII)
K250816 · JNL
Siemens Healthcare Diagnostics, Inc.
Immunology · 261d
Cleared Dec 02, 2025
Disposable Endoscopic Injection Needles
K252021 · FBK
Changzhou New Med Micro-Medtech Co.,...
Gastroenterology & Urology · 155d
Cleared Dec 02, 2025
Aura Wave
K250896 · SGT
Aura Wellness, LLC
Physical Medicine · 252d
Cleared Nov 26, 2025
uDR Arria & uDR Aris
K252000 · KPR
Shanghai United Imaging Healthcare...
Radiology · 152d
Cleared Nov 26, 2025
Tru Kidney Health Test Panel
K251058 · CGX
Truvian Health
Chemistry · 236d
Cleared Nov 25, 2025
Scaida BrainCT-ICH (v1.0)
K250694 · QAS
Mlhealth 360
Radiology · 263d
Cleared Nov 21, 2025
LEGACY
K252696 · HBG
Phasor Health, LLC
Neurology · 86d
Cleared Nov 20, 2025
syngo.MR Applications (VB80)
K253495 · LLZ
Siemens Healthineers AG
Radiology · 23d
Cleared Nov 19, 2025
OptiPAP Junior Flexi Tube US (OPTIPAPFUS)
K250651 · SGR
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 260d
Cleared Nov 14, 2025
IPL Hair Removal Device (I6 S1, I6 D1, I6 M1)
K252618 · OHT
Alovea Healthcare Co. , Ltd.
General & Plastic Surgery · 87d
Cleared Nov 13, 2025
Dental Computed Tomography X-ray System
K251842 · OAS
Fussen Technology Co., Ltd.
Radiology · 150d