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"
553–576 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Apr 03, 2023
Kendall SCD SmartFlow Controller, Cardinal Health Element Sleeves, Kendall...
K230028 · JOW
Cardinal Health200, LLC
Cardiovascular · 89d
Cleared Mar 31, 2023
Spectrum IQ Infusion System with Dose IQ Safety Software
K230041 · FRN
Baxter Healthcare Corporation
General Hospital · 84d
Cleared Mar 31, 2023
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library
K230022 · FRN
Baxter Healthcare Corporation
General Hospital · 86d
Cleared Mar 28, 2023
Gas Insufflator
K221995 · HIF
Surgnova Healthcare Technologies...
Obstetrics & Gynecology · 265d
Cleared Mar 24, 2023
SmartMTA Capsule
K230797 · KIF
Sprig Oral Health Technologies, Inc.
Dental · 2d
Cleared Mar 24, 2023
Nitrile Powder Free Black Patient Examination Gloves, Non-sterile, Tested for...
K230002 · LZA
Mah Sing Healthcare Sdn. Bhd.
General Hospital · 80d
Cleared Mar 24, 2023
Canary Tibial Extension (CTE) with Canary Health Implanted Reporting...
K223803 · QPP
Canary Medical USA, LLC
Orthopedic · 95d
Cleared Mar 23, 2023
3M V.A.C. Veraflo Cleanse Choice Dressing Kit, 3M Veraflo Cleanse Choice...
K221585 · OMP
3M Healthcare Business Group
General & Plastic Surgery · 295d
Cleared Mar 22, 2023
Stativ® Knotted UHMWPE Suture Anchor
K223889 · MBI
Healthium Medtech Limited
Orthopedic · 85d
Cleared Mar 21, 2023
Syngo Carbon Space VA30A
K230561 · LLZ
Siemens Healthcare GmbH
Radiology · 21d
Cleared Mar 20, 2023
MOBINEURO Alita Intraoperative MRI System
K223875 · LNH
Sino Canada Health Engineering...
Radiology · 87d
Cleared Mar 20, 2023
Atellica® CH Diazo Total Bilirubin (D_TBil)
K222104 · CIG
Siemens Healthcare Diagnostics, Inc.
Chemistry · 245d
Cleared Mar 17, 2023
Prism
K222101 · HCC
Graymatters Health , Ltd.
Neurology · 242d
Cleared Mar 17, 2023
RCRP Flex reagent cartridge
K221119 · DCN
Siemens Healthcare Diagnostics, Inc.
Immunology · 333d
Cleared Mar 15, 2023
Air Compression Leg Massager (model: EMK-701)
K222991 · IRP
Xiamen Emoka Health Science &...
Physical Medicine · 168d
Cleared Mar 14, 2023
ONE-CUF
K230145 · DXQ
Ge Medical Systems Information...
Cardiovascular · 55d
Cleared Mar 10, 2023
uMI Panorama
K223325 · KPS
Shanghai United Imaging Healthcare...
Radiology · 130d
Cleared Mar 10, 2023
lntravascular Administration Sets with Stopcock and Manifold
K223175 · FMG
Baxter Healthcare Corporation
General Hospital · 150d
Cleared Mar 07, 2023
Visby Medical Sexual Health Test
K220407 · QEP
Visby Medical
Microbiology · 386d
Cleared Mar 07, 2023
Grosz Warming Liquid, Grosz Play Tingling, Grosz KY Yours & Mine
K213892 · NUC
Rb Health (Us), LLC
Obstetrics & Gynecology · 448d
Cleared Mar 06, 2023
Savvy Surgical Mask - Level 3
K230383 · FXX
Alg Health, LLC
General Hospital · 21d
Cleared Mar 02, 2023
NEBA® Compact EEG2R Mobile Headset
K223628 · OMC
Neba Health, LLC
Neurology · 87d
Cleared Mar 01, 2023
Xeleris V Processing and Review System
K221680 · LLZ
Ge Healthcare
Radiology · 265d
Not Cleared Feb 24, 2023
Caption Interpretation Automated Ejection Fraction Software
DEN220063 · QVD
Caption Health, Inc.
Radiology · 149d