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
1537–1560 of 17,825
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Nov 26, 2021
Synthetic Nitrile Examination Gloves
K212488 · LYZ
Shandong Hongxin Chemicals Co., Ltd.
General Hospital · 109d
Cleared Nov 26, 2021
CUBE Air Purifier
K211139 · FRA
Samsung Electronics Co., Ltd.
General Hospital · 224d
Cleared Nov 26, 2021
Medical surgical mask
K202842 · FXX
Henan Huibo Medical Co., Ltd.
General Hospital · 427d
Cleared Nov 24, 2021
Disposable Isolation Gown -Level 3, Large, Blue, Disposable Isolation Gown -...
K212633 · FYC
String King Lacrosse, LLC
General Hospital · 97d
Cleared Nov 24, 2021
Non-Contact Infrared Thermometer, model HL710H
K211744 · FLL
Health & Life Co., Ltd.
General Hospital · 170d
Cleared Nov 24, 2021
Surgical Mask (sterile)
K211295 · FXX
Nanjing 3h Medical Products Co., Ltd.
General Hospital · 210d
Cleared Nov 23, 2021
039 Surgical Face Mask
K211956 · FXX
Aok Tooling Limited
General Hospital · 152d
Cleared Nov 23, 2021
Cardinal Health RoyalSilk Surgical Gown, Cardinal Health RoyalSilk Scrub...
K211765 · FYA
Cardinal Health, LLC
General Hospital · 168d
Cleared Nov 23, 2021
PCEA Syringe Set
K211649 · PWH
Baxter Healthcare Corporation
General Hospital · 179d
Cleared Nov 22, 2021
Non-sterile Powder Free Nitrile Examination Gloves
K210990 · LZA
Rubberex Alliance Sdn Bhd
General Hospital · 234d
Cleared Nov 19, 2021
Disposable Nitrile Examination Glove
K212661 · LZA
Inner Mongolia Cureguard Medical...
General Hospital · 88d
Cleared Nov 19, 2021
BD Nano 2nd Gen Pen Needle
K212015 · FMI
Becton, Dickinson and Company
General Hospital · 144d
Cleared Nov 19, 2021
HALYARD Flexaprene Green Powder-Free Exam Glove
K211063 · LZA
O&M Halyard, Inc.
General Hospital · 224d
Cleared Nov 19, 2021
Disposable Latex Examination Gloves (Non-Sterile), Disposable Nitrile...
K203074 · LYY
Pt. Universal Gloves
General Hospital · 406d
Cleared Nov 18, 2021
Savvy Mask - Level 3 Surgical Face Mask
K213406 · FXX
Texas Medplast, LLC
General Hospital · 30d
Cleared Nov 18, 2021
Stratum® Ankle Fusion Plating System
K212640 · HRS
Nextremity Solutions, Inc.
General Hospital · 90d
Cleared Nov 18, 2021
Disposable Medical Nitrile Examination Gloves (Non-sterile)
K212600 · LZA
Suqian Linglian Medical Technology...
General Hospital · 93d
Cleared Nov 18, 2021
Impertech Surgical Face Mask
K212046 · FXX
Impertech Industries , Ltd.
General Hospital · 141d
Cleared Nov 17, 2021
Promisemed Sharps container
K211890 · MMK
Promisemed Hangzhou Meditech Co., Ltd.
General Hospital · 149d
Cleared Nov 17, 2021
Protect X Level 3 Isolation Gown
K211538 · FYC
Azac Group
General Hospital · 183d
Cleared Nov 17, 2021
Disposable Surgical Mask
K210042 · FXX
Suzhou Letian Protective Products...
General Hospital · 314d
Cleared Nov 16, 2021
Surgical Mask
K212344 · FXX
Xiantao Dingcheng Non-Woven Product...
General Hospital · 111d
Cleared Nov 16, 2021
Disposable Medical Nitrile Examination Gloves (non-sterile)
K212029 · LZA
Taizhou Kangjian Medical Equipments...
General Hospital · 140d
Cleared Nov 16, 2021
Ultipor U55/U55N Breathing Circuit Filter and Heat and Moisture Exchanger
K211286 · CAH
Pall Corporation
General Hospital · 203d