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
1321–1344 of 17,825
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Mar 22, 2022
AMSafe Pre-Filled Normal Saline Flush Syringe
K213522 · NGT
Amsino International, Inc.
General Hospital · 139d
Cleared Mar 18, 2022
CELERITY 20 HP Challenge Pack
K220473 · FRC
Steris
General Hospital · 28d
Cleared Mar 18, 2022
Powder Free Nitrile Examination Gloves, Blue and Violet Blue, Test For Use...
K220228 · LZA
Shandong Blue Sail Health Technology...
General Hospital · 50d
Cleared Mar 18, 2022
Non-contact Infrared Thermometer (Models WL-301, WL-501, WL-601, WL-701)
K210171 · FLL
Sichuan Youkede Medical Equipment...
General Hospital · 420d
Cleared Mar 18, 2022
Dukal Sterile AAMI Level 3 Reinforced Surgical Gown, Sterile AAMI Level 3...
K203237 · FYA
Dukal Corporation
General Hospital · 500d
Cleared Mar 16, 2022
Intera Refill Kit
K213823 · PTI
Intera Oncology, Inc.
General Hospital · 98d
Cleared Mar 15, 2022
Disposable Nitrile Examination Glove
K213121 · LZA
Jiangsu Cureguard Glove Co., Ltd.
General Hospital · 169d
Cleared Mar 14, 2022
CareGUARD Sterilization Wrap
K213907 · FRG
Care Essentials Pty, Ltd.
General Hospital · 90d
Cleared Mar 14, 2022
DWFritz ASM2000
K213894 · FXX
Dwfritz Automation, Inc.
General Hospital · 90d
Cleared Mar 14, 2022
Yadu Medical Face Mask (Level 1)
K212330 · FXX
Henan Yadu Industrial Co., Ltd.
General Hospital · 230d
Cleared Mar 14, 2022
Qitexio
K203738 · FMF
Medex
General Hospital · 447d
Cleared Mar 12, 2022
Disposable Medical Face Mask
K213806 · FXX
Xiantao Zhibo Nonwoven Products Co.,...
General Hospital · 96d
Cleared Mar 11, 2022
Sterile Safety Syringe with Needle for Single Use, Sterile Safety Hypodermic...
K212920 · FMF
Shandong Weigao Group Medical Polymer...
General Hospital · 178d
Cleared Mar 11, 2022
Maxima Surgical Gown
K201351 · FYA
Elevate Textiles
General Hospital · 659d
Cleared Mar 10, 2022
Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide
K220361 · NZA
STERIS Corporation
General Hospital · 30d
Cleared Mar 10, 2022
Sterilization Wraps
K220133 · FRG
Weihai Hongyu Nonwoven Fabric...
General Hospital · 51d
Cleared Mar 10, 2022
Disposable Medical Nitrile Examination Gloves- Tested for Use with...
K213910 · LZC
Changzhou Universal Medical Equipment...
General Hospital · 85d
Cleared Mar 10, 2022
Powder-Free Green Biodegradable Nitrile Examination Glove Tested for Use with...
K213373 · LZA
Smart Glove Corporation Sdn. Bhd.
General Hospital · 149d
Cleared Mar 10, 2022
Infrared Forehead Thermometer, model: HS-9802D
K213038 · FLL
Jiaxing Shangjia Intelligence...
General Hospital · 170d
Cleared Mar 10, 2022
Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for...
K212148 · LZA
Ansell Healthcare Products, LLC
General Hospital · 244d
Cleared Mar 09, 2022
Disposable Medical Nitrile gloves
K213851 · LZA
Guangdong Xingcan Brothers Medical...
General Hospital · 89d
Cleared Mar 09, 2022
BD Insulin Syringe (0.3mL)
K212499 · FMF
Becton, Dickinson and Company
General Hospital · 212d
Cleared Mar 08, 2022
Medical Face Mask
K214087 · FXX
Hubei Medlink Healthcare Co., Ltd.
General Hospital · 71d
Cleared Mar 04, 2022
Surgical Gown
K213703 · FYA
Wujiang Tutaike Textiles & Finishing...
General Hospital · 100d