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"
505–528 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jul 27, 2023
Cardinal Health™ SmartGown™ EDGE Breathable Surgical Gown with ASSIST™...
K230838 · FYA
Cardinal Health200, LLC
General Hospital · 122d
Cleared Jul 26, 2023
uMI Panorama
K231572 · KPS
Shanghai United Imaging Healthcare...
Radiology · 56d
Cleared Jul 25, 2023
A-LYTE® Integrated Multisensor (IMT Na K Cl)
K222438 · JGS
Siemens Healthcare Diagnostics, Inc.
Chemistry · 347d
Cleared Jul 25, 2023
Emit® II Plus Buprenorphine Assay
K221605 · DJG
Siemens Healthcare Diagnostics, Inc.
Toxicology · 418d
Cleared Jul 20, 2023
uOmnispace
K230039 · QIH
Shanghai United Imaging Healthcare...
Radiology · 195d
Cleared Jul 19, 2023
syngo.CT Lung CAD (Version VD30)
K231157 · OEB
Siemens Healthcare GmbH
Radiology · 86d
Cleared Jul 14, 2023
JiveX (Model Number / Release: 5.4)
K231041 · LLZ
Visus Health IT GmbH
Radiology · 93d
Cleared Jul 13, 2023
ECHELON Synergy MRI system
K223426 · LNH
Fujifilm Healthcare Corporation
Radiology · 241d
Cleared Jul 13, 2023
Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra...
K222116 · JLW
Siemens Healthcare Diagnostics, Inc.
Chemistry · 360d
Cleared Jul 07, 2023
ANDORATE® Valve Kit
K230932 · OCX
Ga Health Company Limited
Gastroenterology & Urology · 95d
Cleared Jul 07, 2023
AeviceMD
K223382 · DSH
Aevice Health Pte. , Ltd.
Anesthesiology · 242d
Cleared Jul 03, 2023
Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 3 )
K230569 · FXX
Cardinalhealth
General Hospital · 124d
Cleared Jun 29, 2023
F&P 950 Accessory Breathing Circuit Kits
K221436 · BZD
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 408d
Cleared Jun 21, 2023
Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110)
K223376 · MEG
Cardinal Health200, LLC
General Hospital · 229d
Cleared Jun 20, 2023
HepaFatSmart (V2.0.0)
K231459 · LNH
Resonance Health Analysis Services...
Radiology · 32d
Cleared Jun 20, 2023
Belle Sensilube
K230781 · NUC
Rb Health (Us), LLC
Obstetrics & Gynecology · 90d
Cleared Jun 16, 2023
Surgical Gown
K222999 · FYA
Hubei Woozon Healthcare Co., Ltd.
General Hospital · 261d
Cleared Jun 16, 2023
F&P 950 Respiratory Humidifier
K220703 · BTT
Fisher & Paykel Healthcare
Anesthesiology · 463d
Cleared Jun 12, 2023
Atellica® CH Diazo Direct Bilirubin (D_DBil)
K223078 · CIG
Siemens Healthcare Diagnostics, Inc.
Chemistry · 255d
Cleared Jun 07, 2023
Ambra PACS
K231360 · LLZ
Dicom Grid Dba Ambra Health
Radiology · 28d
Not Cleared Jun 06, 2023
Cue COVID-19 Molecular Test
DEN220028 · QWB
Cue Health, Inc.
Microbiology · 400d
Cleared Jun 02, 2023
ADVIA Centaur® Anti-Müllerian Hormone (AMH)
K221801 · PQO
Siemens Healthcare Diagnostics, Inc.
Toxicology · 346d
Cleared Jun 02, 2023
vWF Ag
K220728 · GGP
Siemens Healthcare Diagnostics...
Hematology · 445d
Cleared Jun 01, 2023
ANT-X System
K230185 · OWB
Ndr Medical Technology Pte. , Ltd.
Radiology · 129d