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"
625–648 of 5,275
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
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
Cleared Dec 21, 2022
AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS)
K222867 · NUH
Andon Health Co, Ltd.
Neurology · 90d
Cleared Dec 21, 2022
inspired™ VHB20 Heated Humidifier
K222351 · BTT
Vincent Healthcare Products Limited
Anesthesiology · 139d
Cleared Dec 20, 2022
Kangaroo OMNI™ Enteral Feeding Pump (385400 )
K221603 · LZH
Cardinal Health, LLC
General Hospital · 201d
Cleared Dec 16, 2022
Saige-Density
K222275 · QIH
DeepHealth, Inc.
Radiology · 140d
Cleared Dec 16, 2022
CardioPhase® hsCRP
K212559 · NQD
Siemens Healthcare Diagnostics...
Chemistry · 490d
Cleared Dec 13, 2022
Conductive Gel
K222770 · GYB
Top-Rank Health Care Co., Ltd.
Neurology · 90d
Cleared Dec 09, 2022
Wearable breast pump
K221598 · HGX
Mayborn (Uk) Limited
Obstetrics & Gynecology · 190d
Cleared Dec 03, 2022
truSculpt flex
K212866 · NGX
Johari Digital Healthcare Limited
Physical Medicine · 451d
Cleared Dec 01, 2022
Nitrile Patient Examination Gloves Tested For Use With Chemotherapy Drugs
K221747 · LZA
Fitone Latex Products Co., Ltd....
General Hospital · 168d