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

5,275 results for "health"
601–624 of 5,275
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Mar 21, 2023
Syngo Carbon Space VA30A
K230561 · LLZ
Siemens Healthcare GmbH
Radiology · 21d
Cleared Mar 20, 2023
MOBINEURO Alita Intraoperative MRI System
K223875 · LNH
Sino Canada Health Engineering...
Radiology · 87d
Cleared Mar 20, 2023
Atellica® CH Diazo Total Bilirubin (D_TBil)
K222104 · CIG
Siemens Healthcare Diagnostics, Inc.
Chemistry · 245d
Cleared Mar 17, 2023
Prism
K222101 · HCC
Graymatters Health , Ltd.
Neurology · 242d
Cleared Mar 17, 2023
RCRP Flex reagent cartridge
K221119 · DCN
Siemens Healthcare Diagnostics, Inc.
Immunology · 333d
Cleared Mar 15, 2023
Air Compression Leg Massager (model: EMK-701)
K222991 · IRP
Xiamen Emoka Health Science &...
Physical Medicine · 168d
Cleared Mar 14, 2023
ONE-CUF
K230145 · DXQ
Ge Medical Systems Information...
Cardiovascular · 55d
Cleared Mar 10, 2023
uMI Panorama
K223325 · KPS
Shanghai United Imaging Healthcare...
Radiology · 130d
Cleared Mar 10, 2023
lntravascular Administration Sets with Stopcock and Manifold
K223175 · FMG
Baxter Healthcare Corporation
General Hospital · 150d
Cleared Mar 07, 2023
Visby Medical Sexual Health Test
K220407 · QEP
Visby Medical
Microbiology · 386d
Cleared Mar 07, 2023
Grosz Warming Liquid, Grosz Play Tingling, Grosz KY Yours & Mine
K213892 · NUC
Rb Health (Us), LLC
Obstetrics & Gynecology · 448d
Cleared Mar 06, 2023
Savvy Surgical Mask - Level 3
K230383 · FXX
Alg Health, LLC
General Hospital · 21d
Cleared Mar 02, 2023
NEBA® Compact EEG2R Mobile Headset
K223628 · OMC
Neba Health, LLC
Neurology · 87d
Cleared Mar 01, 2023
Xeleris V Processing and Review System
K221680 · LLZ
Ge Healthcare
Radiology · 265d
Not Cleared Feb 24, 2023
Caption Interpretation Automated Ejection Fraction Software
DEN220063 · QVD
Caption Health, Inc.
Radiology · 149d
Cleared Feb 23, 2023
Jumong General
K230241 · KPR
Sg Healthcare Co, Ltd.
Radiology · 24d
Cleared Feb 16, 2023
uCT ATLAS Astound with uWS-CT-Dual Energy Analysis
K223028 · JAK
Shanghai United Imaging Healthcare...
Radiology · 140d
Cleared Feb 15, 2023
Arm Blood Pressure Monitor
K222869 · DXN
Andon Health Co, Ltd.
Cardiovascular · 146d
Cleared Feb 13, 2023
syngo.via View&GO VA40A
K230196 · LLZ
Siemens Healthcare GmbH
Radiology · 19d
Cleared Feb 13, 2023
Rhino Non-sterile Powder-Free Nitrile Exam Glove – Periwinkle Color Tested...
K223859 · LZA
Rhino Health, Inc.
General Hospital · 52d
Cleared Feb 13, 2023
SIGNA Victor
K223439 · LNH
Ge Healthcare (Tianjin) Company Limited
Radiology · 91d
Cleared Feb 10, 2023
PRIMUS Healthcare Sterilizer (Model PSS11-HC)
K221474 · FLE
Primus Sterilizer Company, LLC
General Hospital · 266d
Cleared Feb 10, 2023
SEJONG Surgical Gown Soft
K220435 · FYA
Sejong Healthcare Co., Ltd.
General Hospital · 361d
Cleared Feb 09, 2023
Toothsi, Smilealigners
K223338 · NXC
Makeo Healthcare Technologies Private...
Dental · 100d