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"
601–624 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
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
Cleared Nov 30, 2022
Rhino Non-Sterile, Powder-Free Nitrile Exam Gloves – Periwinkle Color Tested...
K221082 · LZA
Rhino Health, Inc.
General Hospital · 231d
Cleared Nov 28, 2022
Infrared Thermometer, Model: JKH-300, JKH-301, JKH-302, JKH-303, JKH-304
K211050 · FLL
Jkh Health Co., Ltd.
General Hospital · 599d
Cleared Nov 23, 2022
Closed System Transfer Device
K201460 · ONB
Shinva Ande Healthcare Apparatus Co.,...
General Hospital · 904d
Cleared Nov 22, 2022
Cala kIQ
K222237 · QBC
Cala Health, Inc.
Neurology · 119d
Cleared Nov 22, 2022
Avenda Health AI Prostate Cancer Planning Software
K221624 · POK
Avenda Health, Inc.
Radiology · 169d
Cleared Nov 20, 2022
Empatica Health Monitoring Platform
K221282 · DQA
Empatica S.R.L.
Anesthesiology · 201d
Cleared Nov 18, 2022
Hillrom Heart and Respiration Rate Monitoring System powered by EarlySense
K223246 · BZQ
Baxter Healthcare Corproration
Anesthesiology · 29d
Cleared Nov 18, 2022
Banded Face Mask
K223003 · FXX
Hubei Medlink Healthcare Co., Ltd.
General Hospital · 50d
Cleared Nov 18, 2022
Opulent TiNbN Coated Knee
K222816 · JWH
Meril Healthcare Pvt. , Ltd.
Orthopedic · 60d
Cleared Nov 17, 2022
SKR 3000
K223267 · MQB
Konica Minolta, Inc.
Radiology · 24d
Cleared Nov 17, 2022
Blood Administration Sets
K220558 · BRZ
Baxter Healthcare Corporation
General Hospital · 262d
Cleared Nov 14, 2022
uPMR 790
K222540 · OUO
Shanghai United Imaging Healthcare...
Radiology · 84d
Cleared Nov 10, 2022
AquaPulse® Irrigation Tubing
K223171 · OCX
Ga Health Company Limited
Gastroenterology & Urology · 30d
Cleared Nov 10, 2022
Synapse 3D Base Tools v6.6
K221677 · LLZ
Fujifilm Corporation
Radiology · 154d
Cleared Nov 10, 2022
AEYE-DS
K221183 · PIB
Aeye Health, Inc.
Ophthalmic · 199d