Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: General Hospital ×
17,825 results
2497–2520 of 17,825
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared May 06, 2019
Showa(R) Medical Exam Glove (Green) powder-free, disposable nitrile glove
K190159 · LZC
Showa Best Glove, Inc.
General Hospital · 96d
Cleared May 05, 2019
Wireless Intelligent Thermometer
K182437 · FLL
Shenzhen Jumper Medical Equipment...
General Hospital · 240d
Cleared May 02, 2019
K-Shield Advantage Port Access Infusion Set (PAIS)
K190233 · FPA
Kawasumi Laboratories, Inc.
General Hospital · 85d
Cleared Apr 30, 2019
Additive Cap
K190305 · KPE
International Medical Industries, Inc.
General Hospital · 77d
Cleared Apr 30, 2019
BD Intelliport System
K182092 · PHC
Becton, Dickinson and Company
General Hospital · 270d
Cleared Apr 26, 2019
Cardinal HealthTM Poly-Coated Open-Back Protective Gown
K182830 · QPC
Cardinal Health200, LLC
General Hospital · 203d
Cleared Apr 24, 2019
Medline Level 4 Surgical Gown (Sirus), Medline Level 4 Surgical Gown...
K182172 · FYA
Medline Industries, Inc.
General Hospital · 257d
Cleared Apr 23, 2019
Elcam Stopcocks and Manifolds
K190489 · FMG
Elcam Medical Acal
General Hospital · 54d
Cleared Apr 23, 2019
AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor
K181472 · FEB
Advanced Sterilization Products (Asp)
General Hospital · 323d
Cleared Apr 12, 2019
TEEClean(R) Automated TEE Probe Cleaner Disinfector with TEEZyme(R) Cleaner...
K182891 · PSW
Cs Medical, LLC
General Hospital · 179d
Cleared Apr 12, 2019
Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Blue and Violet...
K182640 · LZA
Shandong Hengya Packaging Printing...
General Hospital · 200d
Cleared Apr 10, 2019
Oryum and Ovem Epidermal Deri Prick Test Applicator
K182582 · SCL
Allergy & Applicator Depot, LLC
General Hospital · 203d
Cleared Apr 09, 2019
Adult Intraosseous Infusion Device
K182770 · FMI
Einstein Works, LLC
General Hospital · 193d
Cleared Apr 05, 2019
V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature...
K190103 · MLR
STERIS Corporation
General Hospital · 73d
Cleared Apr 05, 2019
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile,...
K183287 · LZA
Kossan International Sdn Bhd
General Hospital · 130d
Cleared Apr 05, 2019
EpiFaith Syringe (Luer Slip) , EpiFaith Syringe (NRFit)
K182268 · FMF
Flat Medical Co., Ltd.
General Hospital · 227d
Cleared Apr 04, 2019
HIgH-Flo Super26 Subcutaneous Needle Sets
K180843 · FPA
Repro-Med Systems, Inc. Dba Rms...
General Hospital · 367d
Cleared Apr 03, 2019
Infrared thermometer
K182597 · FLL
Shenzhen Pango Electronic Co., Ltd.
General Hospital · 195d
Cleared Mar 28, 2019
Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use...
K182176 · KGO
Pt. Medisafe Technologies
General Hospital · 230d
Cleared Mar 27, 2019
Tyto Thermometer
K190242 · FLL
Tyto Care , Ltd.
General Hospital · 49d
Cleared Mar 27, 2019
AMSCO 600 Steam Sterilizer
K183410 · FLE
STERIS Corporation
General Hospital · 107d
Cleared Mar 26, 2019
Velano Vascular Q2 Extension Set
K182897 · FPA
Velano Vascular
General Hospital · 161d
Cleared Mar 22, 2019
SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid...
K190104 · MED
Steris Corporations
General Hospital · 59d
Cleared Mar 22, 2019
Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy Drugs
K182948 · KGO
Ansell Healthcare Products, LLC
General Hospital · 150d