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"
337–360 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Aug 19, 2024
HealthCCSng
K241440 · JAK
Nano-X AI , Ltd.
Radiology · 90d
Cleared Aug 15, 2024
uMI Panvivo
K241596 · KPS
Shanghai United Imaging Healthcare...
Radiology · 73d
Cleared Aug 15, 2024
CoLumbo
K241211 · QIH
Smart Soft Healthcare
Radiology · 107d
Cleared Aug 13, 2024
ECHELON Synergy MRI System
K241429 · LNH
Fujifilm Healthcare Corporation
Radiology · 84d
Cleared Aug 09, 2024
F&P Optiflow Flow Diverter
K234053 · CBP
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 231d
Cleared Aug 09, 2024
F&P Airvo 3 NIV (PT311US)
K233643 · MNT
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 270d
Cleared Aug 08, 2024
SynthVISION 1.0.0
K240724 · LLZ
Synthesis Health Intelligence, Inc.
Radiology · 143d
Cleared Aug 08, 2024
F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility...
K234058 · BTT
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 230d
Cleared Aug 06, 2024
myAblation Guide (VB80A)
K240796 · QTZ
Siemens Healthcare GmbH
Radiology · 137d
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