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
1513–1536 of 17,825
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Dec 10, 2021
Powder Free, White, Blue, Pink, Black Nitrile Synthetic Rubber Examination...
K212349 · LZA
Medi Legion Sdn.Bhd
General Hospital · 135d
Cleared Dec 10, 2021
Unico Global level 3 Surgical Gown (Film-reinforced SMS), Unico Global Level...
K203539 · FYA
Unicoglobal, Inc.
General Hospital · 372d
Cleared Dec 10, 2021
Infrared thermometer, models KFT-22M, KFT-22, KFT-23, KFT-24, KFT-25, KFT-26,...
K201600 · FLL
Kangfu Medical Equipment Factory
General Hospital · 546d
Cleared Dec 09, 2021
Disposable Medical Nitrile Examination Gloves (Model:XYS-001)
K213371 · LZA
Anhui Xinyisheng Medical Technology...
General Hospital · 58d
Cleared Dec 08, 2021
BD Nano 2nd Gen Pen Needle
K213156 · FMI
Becton, Dickinson and Company
General Hospital · 79d
Cleared Dec 08, 2021
Disposable Medical Nitrile Examination Gloves (Non sterile)
K212639 · LZC
Jiangsu Nanfang Medical Co., Ltd.
General Hospital · 110d
Cleared Dec 08, 2021
Infrared forehead thermometer LD-FT-100B
K211629 · FLL
Honsun (Nantong) Co., Ltd.
General Hospital · 195d
Cleared Dec 08, 2021
MAF Guard
K211487 · FXX
Maf Clothing Pvt Ltd Unit-3
General Hospital · 209d
Cleared Dec 07, 2021
Comfortpro
K212438 · LYY
Thai Rubber Industry Company Limited
General Hospital · 125d
Cleared Dec 07, 2021
BAYLAB 3-Ply Surgical Mask (BEACON I)
K212302 · FXX
Baylab USA, LLC
General Hospital · 137d
Cleared Dec 06, 2021
Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with...
K212827 · LZC
Jr Engineering & Medical Technologies...
General Hospital · 94d
Cleared Dec 06, 2021
Surgical Face Mask
K212235 · FXX
Shanghai Yunqing Industrial Co., Ltd.
General Hospital · 140d
Cleared Dec 06, 2021
PMW01 Procedure Mask Level 1
K211772 · FXX
Defender Safety, Inc.
General Hospital · 181d
Cleared Dec 04, 2021
Nitrile Powder Free Blue Examination Gloves, Non-Sterile
K212535 · LZA
Mah Sing Healthcare Sdn. Bhd.
General Hospital · 115d
Cleared Dec 03, 2021
Surgical Masks
K212807 · FXX
Weihai Hongyu Nonwoven Fabric...
General Hospital · 91d
Cleared Dec 02, 2021
powder free nitrile examination glove - white, non-sterile
K212802 · LZA
Hong Seng Gloves Sdn Bhd
General Hospital · 91d
Cleared Dec 02, 2021
Puravita Medical Fold Flat Surgical Mask
K212740 · FXX
Puravita M, LLC
General Hospital · 94d
Cleared Dec 02, 2021
Nitrile disposable examination gloves
K212578 · LZA
Xingyu Medical Tech Co., Ltd.
General Hospital · 108d
Cleared Dec 02, 2021
Single-use Surgical Mask
K211773 · FXX
Taiwan Seafood and Fish Corporation
General Hospital · 177d
Cleared Dec 01, 2021
Powder free nitrile examination glove- blue, non-sterile
K212804 · LZA
Hong Seng Gloves Sdn Bhd
General Hospital · 90d
Cleared Dec 01, 2021
Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)
K212789 · LZA
5r Med Instruments (Chengdu) Co., Ltd.
General Hospital · 91d
Cleared Nov 30, 2021
Disposable Surgical Face Mask
K211696 · FXX
Anhui Cleanpro Pharmpack Co., Ltd.
General Hospital · 181d
Cleared Nov 30, 2021
InstruSafe Instrument Protection System
K210836 · KCT
Summitt Medical, LLC
General Hospital · 253d
Cleared Nov 26, 2021
Nitrile Examination Gloves
K212722 · LZA
Wuhan Huirui Technology Co., Ltd.
General Hospital · 91d