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
961–984 of 17,825
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Nov 23, 2022
Closed System Transfer Device
K201460 · ONB
Shinva Ande Healthcare Apparatus Co.,...
General Hospital · 904d
Cleared Nov 22, 2022
EasyOne Filter
K221250 · CAH
Ndd Medizintechnik AG
General Hospital · 204d
Cleared Nov 22, 2022
PRIMED Pediatric Facemask
K213427 · OXZ
Primed Medical Products, Inc.
General Hospital · 397d
Cleared Nov 22, 2022
Airdog X5 Recirculating Air Cleaner (model KJ300F-X5)
K211507 · FRF
Beiang Air Tech , Ltd.
General Hospital · 557d
Cleared Nov 21, 2022
Intravenous Needles for Single Use,Safety Intravenous Needles for Single Use
K221078 · FPA
Sichuan Prius Biotechnology Co., Ltd.
General Hospital · 223d
Cleared Nov 21, 2022
Infusion Sets for Single Use
K221075 · FPA
Sichuan Prius Biotechnology Co., Ltd.
General Hospital · 223d
Cleared Nov 21, 2022
Infusion Sets for Single Use with Needles
K221069 · FPA
Sichuan Prius Biotechnology Co., Ltd.
General Hospital · 223d
Cleared Nov 20, 2022
Non-Sterile, Powder-Free Nitrile Examination Glove Violet Blue Tested for use...
K221165 · LZA
Sri Trang Gloves (Thailand) Public...
General Hospital · 212d
Cleared Nov 18, 2022
Banded Face Mask
K223003 · FXX
Hubei Medlink Healthcare Co., Ltd.
General Hospital · 50d
Cleared Nov 17, 2022
Disposable Insulin Pen Needle
K221178 · FMI
Ningbo Medsun Medical Co., Ltd.
General Hospital · 206d
Cleared Nov 17, 2022
Blood Administration Sets
K220558 · BRZ
Baxter Healthcare Corporation
General Hospital · 262d
Cleared Nov 16, 2022
Disposable surgical face mask
K220302 · FXX
Shandong Aida Medical Products Co., Ltd.
General Hospital · 287d
Cleared Nov 16, 2022
Surgical Gown
K212812 · FYA
Xianning Marveldas Protective...
General Hospital · 439d
Cleared Nov 16, 2022
KNH Surgical Face Mask
K203528 · FXX
Knh Surgical Face Mask
General Hospital · 714d
Cleared Nov 14, 2022
High Fluid-Resistant Surgical and Procedure Mask
K222749 · FXX
America?S Supply Chains
General Hospital · 63d
Cleared Nov 14, 2022
Surgical Face Mask
K222529 · FXX
Xiantao Rayxin Medical Products Co.,...
General Hospital · 84d
Cleared Nov 14, 2022
Standard Surgical Gown (AAMI Level 2)
K222480 · FYA
Foshan Nanhai Plus Medical Co, Ltd.
General Hospital · 89d
Cleared Nov 12, 2022
Nitrile Examination Gloves
K213981 · LZA
Emerald Glove Manufacturing Sdn Bhd
General Hospital · 327d
Cleared Nov 11, 2022
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs...
K222225 · LZA
Hartalega NGC Sdn. Bhd.
General Hospital · 109d
Cleared Nov 10, 2022
BD Intraosseous Vascular Access System EMS Powered Driver (D001003)
K223198 · MHC
Bard Access Systems
General Hospital · 28d
Cleared Nov 10, 2022
Humask Pro Vision, Humask Pro Vision 3000
K222551 · FXX
Entreprise Premont, Inc.
General Hospital · 79d
Cleared Nov 10, 2022
Bodygard SFS Surgical Gown Level 4
K221139 · FYA
Feliks Plastik Laminasyon VE Ambalaj...
General Hospital · 205d
Cleared Nov 10, 2022
AMSure Enteral Feeding Pump
K220230 · LZH
Amsino International, Inc.
General Hospital · 287d
Cleared Nov 07, 2022
SafeSource Direct Blue Powder-Free Nitrile Exam Gloves
K222898 · LZA
Safesource Direct, LLC
General Hospital · 45d