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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 33 of 33 Results
ProductCode: ngt Decision Date To: 03/01/2022
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pre-filled syringe with saline Jiangsu Caina Medical Co., Ltd. K220060 06/10/2022
pentaflush PENTAFERTE ITALIA S.R.L. K214080 07/20/2022
amsafe pre-filled normal saline flush syringe Amsino International, Inc. K213522 03/22/2022
0.9% sodium chloride i.v. flush syringe for sterile delivery, 1 syringe/pouch, 0.9% sodium chloride i.v. flush syringe for sterile delivery, 2 syringes/pouch Nurse Assist, LLC K201286 08/11/2020
praxiject 0.9% nacl MedXL Inc. K192414 02/13/2020
0.9% sodium chloride injection, usp, pre-filled cop syringe Medline Industries, Inc. K191378 09/15/2019
amsafe(r) pre-filled normal saline flush syringe Amsino International, Inc. K183473 07/12/2019
0.9% sodium chloride injection, usp Medline Industries, Inc. K173348 06/21/2018
praxiject 0.9% nacl MedXL Inc. K171109 12/21/2017
0.9% sodium chloride injection, usp bd posiflush sp syringe Becton Dickinson and Company K161552 02/02/2017
0.9% sodium chloride injection, usp bd posiflush sf syringe BECTON, DICKINSON AND COMPANY K153481 04/04/2016
normal saline flush NURSE ASSIST, INC. K150143 08/31/2015
0.9% sodium chloride injection, usp - 2.5 ml in 3 ml syringe, 0.9% sodium chloride injection, usp-3ml in 10 ml syringe, 0.9% sodium chloride injection, usp - 5 ml in 10 ml syringe, 0.9% sodium chloride injection, usp - 10 ml in 10 ml syringe Excelsior Medical Corporation K142620 12/12/2014
0.9% sodium chloride injection, usp bd posiflush; sp syringe, sf syringe Becton, Dickinson and Company K141311 07/25/2014
0.9% sodium chloride flush syringe AMUSA K133685 08/13/2014
0.9% sodium chloride injection usp bd posiflush flush syringe, sf flush syringe BECTON DICKINSON & CO. K121050 02/07/2013
0.9% sodium chloride flish syringe AMUSA K120836 07/12/2012
ind drug home multi-panel test (2-5) ind morphine home test IND NDIAGNOSTIC INC. K121231 07/30/2012
medeflush normal saline i.v. flush syringe-sterile field ready MEDEFIL, INC. K121262 09/20/2012
am usa 0.9% sodium chloride flush syringe AM USA K111034 07/14/2011
am usa 0.9% sodium chloride flush syringe AM USA K113555 01/30/2012
sodium chloride injection, 0.9%, usp 5 ml, 10 ml ampule SPECTRA MEDICAL DEVICES, INC. K103740 07/29/2011
swabflsuh (3ml, 5ml, 10ml) model 10331, 10351, 10311 EXCELSIOR MEDICAL CORP. K101270 02/10/2011
flush syringe filled with 0.9% sodium chloride HOSPIRA, INC. K090882 04/23/2010
medefil's normal saline i.v. flush syringe MEDEFIL, INC. K091583 01/28/2010
sterile field saline pre-filled syringe(s) EXCELSIOR MEDICAL CORP. K082837 12/18/2008
sterile sodium chloride 0.9% flush, 5ml, 10ml, ampule SPECTRA MEDICAL DEVICES, INC. K082689 03/20/2009
kendall monoject pre-fill advanced 0.9%sodium chloride flush syringes for sterile delivery TYCO HEALTHCARE/KENDALL K060339 04/28/2006
0.9% sodium chloride injection, usp bd postflush sf flush syringe BECTON DICKINSON K042061 08/26/2004
modification to: monojet prefill 0.9% sodium chloride flush syringe, monojet prefill heprin lock flush syringe TYCO HEALTHCARE K032438 06/30/2004
medefil's normal saline flush syringe in various fill sizes - 1 ml fill in 6 ml syringe ll; 2 ml fill in 6 ml syringe ll MEDEFIL, INC. K020999 06/20/2002
medefil's heparin i.v. flush syringe in various fill sizes - 1 ml fill in 6 ml syringe ll; 2 ml fill in 6 ml syringe ll MEDEFIL, INC. K020996 06/24/2002
monoject prefill 0.9% sodium chloride flush syringe THE KENDALL COMPANY K011283 10/15/2001
 
 
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