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"
385–408 of 5,275
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Aug 05, 2024
Sleepio®
K233577 · QVO
Big Health, Inc.
Neurology · 272d
Cleared Aug 02, 2024
Actifuse ABX
K241564 · MQV
Baxter Healthcare Corporation
Orthopedic · 63d
Cleared Aug 02, 2024
Disposable Ureteral Guide Sheath
K241181 · FED
Dongguan Zsr Biomedical Technology...
Gastroenterology & Urology · 95d
Cleared Jul 26, 2024
Symbia SPECT and SPECT/CT Systems
K241898 · KPS
Siemens Healthineers
Radiology · 28d
Cleared Jul 26, 2024
Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC)
K241800 · MRR
Siemens Healthcare Diagnostics, Inc.
Chemistry · 35d
Cleared Jul 26, 2024
“LARGAN Health AI-Tech” Sleep Apnea and Sleep Quality Examination System...
K233501 · MNR
Largan Medical Co., Ltd.
Anesthesiology · 269d
Cleared Jul 25, 2024
Atellica® IM High-Sensitivity Troponin I (TnIH)
K241165 · MMI
Siemens Healthcare Diagnostics, Inc.
Chemistry · 90d
Cleared Jul 22, 2024
Transcutaneous Electrical Nerve Stimulator (K6106)
K241119 · NUH
Shenzhen Yicai Health Technology Co.,...
Neurology · 90d
Cleared Jul 03, 2024
Upper Arm Electronic Blood Pressure Monitor
K241129 · DXN
Shenzhen Goodlymed Technology Co., Ltd.
Cardiovascular · 70d
Cleared Jul 02, 2024
ViewPoint 6
K241300 · LLZ
Ge Healthcare GmbH
Radiology · 54d
Cleared Jul 02, 2024
Freedom® Total Knee System
K240863 · JWH
Maxx Orthopedics, Inc.
Orthopedic · 96d
Cleared Jul 01, 2024
Reprocessed Super Torque and Super Torque Plus Diagnostic Angiographic Catheters
K231015 · NLI
Innovative Health, LLC
Cardiovascular · 448d
Cleared Jun 28, 2024
Electric Wheelchair (YFWB-63)
K241154 · ITI
If Health (Xiamen) Intelligent...
Physical Medicine · 63d
Cleared Jun 21, 2024
Merge Hemo, Model RCSV2
K233326 · DQK
Merge Healthcare Incorporated
Cardiovascular · 266d
Cleared Jun 21, 2024
PRESSUREALERT® Pressure Monitoring System
K233096 · SBO
Position Health, LLC
General Hospital · 269d
Cleared Jun 14, 2024
Clarius OB AI
K233955 · IYN
Clarius Mobile Health Corp.
Radiology · 182d
Cleared Jun 14, 2024
Smart Scope® CX
K233043 · HEX
Periwinkle Technologies Pvt., Ltd.
Obstetrics & Gynecology · 263d
Cleared Jun 13, 2024
F&P Optiflow Oxygen Kit (AA451J)
K233821 · BTT
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 195d
Cleared Jun 13, 2024
Double Balloon Endoscope EN-840T, Over-tube TS-1214C
K233321 · FDA
Fujifilm Healthcare Americas Corporation
Gastroenterology & Urology · 258d
Cleared Jun 07, 2024
Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter
K233825 · NLH
Innovative Health
Cardiovascular · 189d
Cleared Jun 03, 2024
ANNE Chest
K240251 · DRG
Sibel Health, Inc.
Cardiovascular · 125d
Cleared May 31, 2024
Bone Suppression Software
K240281 · LLZ
Konica Minolta, Inc.
Radiology · 120d
Cleared May 31, 2024
iHealth COVID-19 Antigen Rapid Test
K233842 · QYT
Ihealth Labs, Inc.
Microbiology · 179d
Cleared May 28, 2024
ANNE Limb
K240305 · DQA
Sibel Health, Inc.
Cardiovascular · 116d