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"
97–120 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Not Cleared Jan 16, 2026
Sana Device
DEN250005 · QYN
Sana Health
Neurology · 319d
Cleared Jan 15, 2026
BIOGRAPH One
K253023 · OUO
Siemens Healthineers AG
Radiology · 118d
Cleared Jan 14, 2026
Cardinal Health Nitrile Examination Gloves Extended Cuff
K252313 · LZC
Cardinalhealth
General Hospital · 173d
Cleared Jan 12, 2026
Dr. Yglo Skin Tag Remover
K251524 · GEH
Theotclab Healthcare B.V.
General & Plastic Surgery · 241d
Cleared Jan 09, 2026
Core Metabolic
K251157 · CIX
Truvian Health
Chemistry · 269d
Cleared Jan 08, 2026
3DICOM MD Cloud
K253784 · LLZ
Singular Health Pty, Ltd.
Radiology · 43d
Cleared Jan 08, 2026
View
K253639 · LLZ
Ge Healthcare
Radiology · 50d
Cleared Jan 07, 2026
Reprocessed Agilis NxT Steerable Introducer
K250305 · PNE
Innovative Health
Cardiovascular · 338d
Cleared Jan 05, 2026
Atellica IM Total PSA II (tPSAII)
K251630 · LTJ
Siemens Healthcare Diagnostics, Inc.
Immunology · 222d
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