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"
649–672 of 5,275
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
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
Cleared Nov 10, 2022
FUJIFILM Endoscope Model EB-710P
K220957 · EOQ
Fujifilm Corporaton
Ear, Nose, Throat · 223d
Cleared Nov 08, 2022
Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing
K222734 · OCX
Diversatek Healthcare
Gastroenterology & Urology · 60d
Cleared Nov 07, 2022
Durex Patronus CloseFit, Durex Patronus Regular
K220489 · HIS
Rb Health (Us), LLC
Obstetrics & Gynecology · 258d
Cleared Nov 07, 2022
Eclipse MINI Model 98900
K212317 · MWJ
Spacelabs Healthcare, Ltd.
Cardiovascular · 469d
Cleared Nov 02, 2022
Powder Free Nitrile Examination Gloves (Blue), Tested for Use with...
K223320 · LZA
Lingshi Hongruida Health Protection...
General Hospital · 5d
Cleared Nov 01, 2022
POSE™ Health Care Surgical Mask
K223270 · FXX
America?S Supply Chains
General Hospital · 8d
Cleared Nov 01, 2022
Current Health System
K222550 · MSX
Current Health , Ltd.
Cardiovascular · 70d
Cleared Oct 27, 2022
AlphaID™ At Home Genetic Health Risk Service
K221420 · PTA
Progenika Biopharma S.A., A Grifols...
Immunology · 164d
Cleared Oct 27, 2022
uMR Omega with uWS-MR-MRS
K220332 · LNH
Shanghai United Imaging Healthcare...
Radiology · 265d