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"
577–600 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
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
Cleared Feb 06, 2023
Videa Perio Assist
K223296 · QIH
Videahealth, Inc.
Radiology · 103d
Cleared Feb 06, 2023
Care Team Portal
K222398 · DRG
Vivify Health, Inc.
Cardiovascular · 182d
Cleared Jan 27, 2023
FUJIFILM Endoscope Model EI-740D/S
K221551 · FDS
Fujifilm Corporaton
Gastroenterology & Urology · 241d
Cleared Jan 27, 2023
F&P Airvo 3
K221338 · QAV
Fisher & Paykel Healthcare
Anesthesiology · 263d
Cleared Jan 26, 2023
Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile, Tested for...
K223415 · LZA
Mah Sing Healthcare Sdn. Bhd.
General Hospital · 77d
Cleared Jan 26, 2023
ECHELON Oval V6.2 MRI System
K221619 · LNH
Fujifilm Healthcare Corporation
Radiology · 237d
Cleared Jan 23, 2023
Clarius AI
K222406 · QIH
Clarius Mobile Health Corp.
Radiology · 167d
Cleared Jan 20, 2023
DRX - Compass
K223842 · KPR
Carestream Health, Inc.
Radiology · 29d
Cleared Jan 19, 2023
Medaica M1 Telehealth Stethoscope
K223166 · DQD
Medaica, Inc.
Cardiovascular · 104d
Cleared Jan 13, 2023
Power Acute Triple Lumen Hemodialysis Catheter
K222170 · NIE
Health Line International Corporation
Gastroenterology & Urology · 176d
Cleared Jan 04, 2023
Surgical Face Mask
K222483 · FXX
Hubei Woozon Healthcare Co., Ltd.
General Hospital · 140d
Cleared Jan 03, 2023
3.0T 16ch AIR AA
K223378 · MOS
Ge Healthcare Coils (Usa Instruments,...
Radiology · 57d
Cleared Dec 30, 2022
PeekMed web (v1)
K222767 · LLZ
Peek Health, S.A.
Radiology · 108d
Cleared Dec 29, 2022
Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA), Well-Life...
K222528 · KPI
Well-Life Healthcare Limited
Gastroenterology & Urology · 129d
Cleared Dec 22, 2022
Philips CT 3500
K223311 · JAK
Philips Healthcare (Suzhou) Co., Ltd.
Radiology · 55d