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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: General Hospital ×
17,791 results
1513–1536 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
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
Cleared Nov 15, 2021
Sterile Disposable Syringe with Saftey Needle, Sterile Disposable Syringe...
K211329 · MEG
Jiangsu Kangbao Medical Equipment...
General Hospital · 196d
Cleared Nov 14, 2021
Surgical Face Mask
K212575 · FXX
Hubei Huanfu Plastic Products Co., Ltd.
General Hospital · 90d
Cleared Nov 14, 2021
Spin Care Disposable Protective Mask Level 3
K212109 · FXX
Spintech, LLC
General Hospital · 131d
Cleared Nov 13, 2021
Surgical Face mask
K212264 · FXX
Nantong Taiweishi Medical Technology...
General Hospital · 116d
Cleared Nov 13, 2021
Disposable Surgical Gowns
K210785 · FYC
Chongqing Litai Fashion Group Limited...
General Hospital · 242d
Cleared Nov 12, 2021
Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type)
K202319 · FMI
Tianjin Huahong Technology Co., Ltd.
General Hospital · 452d
Cleared Nov 11, 2021
Disposable Powder Free Nitrile Exam Gloves (Tested For Use With Chemotherapy...
K212532 · LZA
Crdlight Optoelectronic Technology...
General Hospital · 92d
Cleared Nov 11, 2021
Nitrile Examination Glove (Powder free, Blue)
K212497 · LZA
Jiangsu Jinlian Medical Technology...
General Hospital · 94d
Cleared Nov 10, 2021
Ivenix Infusion System, LVP Epidural Administraion Set NRFit Connector
K213089 · FPA
Ivenix, Inc.
General Hospital · 47d
Cleared Nov 10, 2021
Powder Free Nitrile Patient Examination Gloves, Blue Color
K210779 · LZA
Shandong Shangwei Medical Products...
General Hospital · 240d