Panels › General Hospital › Product code NGT · Class 2
Saline, Vascular Access Flush
Regulation 880.5200
1510(k)s in 12 months (40 all time)
1recalls in 12 months (61 all time)
56recalls that name a 510(k)
Top companies in NGT
| Company | 510(k)s | Recalls |
|---|---|---|
| Covidien LLC | 0 | 28 |
| Becton Dickinson | 2 | 5 |
| Excelsior Medical Corp. | 3 | 3 |
| Becton, Dickinson and Company | 5 | 0 |
| Nurse Assist, Inc. | 2 | 3 |
| Am USA | 4 | 0 |
| Medefil, Inc. | 4 | 0 |
| Medline Industries, Inc. | 2 | 2 |
| Medxl, Inc. | 4 | 0 |
| Cardinal Health | 0 | 3 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 2, 2025 | K250884 | 0.9 % Sodium Chloride Injection, USP, BD PosiFlush SP Syringe Becton, Dickinson and Company | NGT |
| Feb 27, 2024 | K233623 | Praxiject SP 0.9% NaCl Medxl, Inc., CA | NGT |
| Nov 9, 2023 | K231724 | Flush Syringe (Prefilled 0.9% normal saline solution) Spm Medicare Pvt. , Ltd., IN | NGT |
| Sep 27, 2023 | K231363 | Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010) Hantech Medical Device Co., Ltd., CN | NGT |
| Aug 12, 2023 | K230756 | TK Pre-Filled Normal Saline Flush Syringe Anhui Tiankang Medical Technology Co., Ltd., CN | NGT |
| Aug 12, 2023 | K223584 | Pre-Filled Normal Saline Flush Syringe Anhui Tianyang Pharmaceutical Co., Ltd., CN | NGT |
| Jul 21, 2023 | K231161 | 0.9% Sodium Chloride Injection, USP BD PosiFlush SF Saline Flush Syringe Becton, Dickinson and Company | NGT |
| Jul 13, 2023 | K231754 | Praxiject 0.9% NaCl Medxl, Inc., CA | NGT |
| Jul 20, 2022 | K214080 | Pentaflush Pentaferte Italia S.R.L., IT | NGT |
| Mar 22, 2022 | K213522 | AMSafe Pre-Filled Normal Saline Flush Syringe Amsino International, Inc. | NGT |
| Aug 11, 2020 | K201286 | 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 1 syringe/pouch, 0.9% Sodium Chloride I.V. Flush Syringe f Nurse Assist, LLC | NGT |
| Feb 13, 2020 | K192414 | Praxiject 0.9% NaCl Medxl, Inc., CA | NGT |
| Sep 15, 2019 | K191378 | 0.9% Sodium Chloride Injection, USP, Pre-filled COP Syringe Medline Industries, Inc. | NGT |
| Jul 12, 2019 | K183473 | AMSafe(R) Pre-Filled Normal Saline Flush Syringe Amsino International, Inc. | NGT |
| Jun 21, 2018 | K173348 | 0.9% Sodium Chloride Injection, USP Medline Industries, Inc. | NGT |
| Dec 21, 2017 | K171109 | Praxiject 0.9% NaCl Medxl, Inc., CA | NGT |
| Feb 2, 2017 | K161552 | 0.9% Sodium Chloride Injection, USP BD PosiFlush SP Syringe Becton, Dickinson and Company | NGT |
| Apr 4, 2016 | K153481 | 0.9% Sodium Chloride Injection, USP BD PosiFlush SF Syringe Becton, Dickinson and Company | NGT |
| Aug 31, 2015 | K150143 | Normal Saline Flush Nurse Assist, Inc. | NGT |
| Dec 12, 2014 | K142620 | 0.9% Sodium Chloride Injection, USP - 2.5 mL in 3 mL Syringe, 0.9% Sodium Chloride Injection, USP-3mL in 10 mL Syringe, Excelsior Medical Corporation | NGT |
| Aug 13, 2014 | K133685 | 0.9% SODIUM CHLORIDE FLUSH SYRINGE Am USA | NGT |
| Jul 25, 2014 | K141311 | 0.9% SODIUM CHLORIDE INJECTION, USP BD POSIFLUSH; SP SYRINGE, SF SYRINGE Becton, Dickinson and Company | NGT |
| Feb 7, 2013 | K121050 | 0.9% SODIUM CHLORIDE INJECTION USP BD POSIFLUSH FLUSH SYRINGE, SF FLUSH SYRINGE Becton, Dickinson & CO | NGT |
| Sep 20, 2012 | K121262 | MEDEFLUSH NORMAL SALINE I.V. FLUSH SYRINGE-STERILE FIELD READY Medefil, Inc. | NGT |
| Jul 30, 2012 | K121231 | IND DRUG HOME MULTI-PANEL TEST (2-5) IND MORPHINE HOME TEST Ind Ndiagnostic, Inc., CA | NGT |
| Jul 12, 2012 | K120836 | 0.9% SODIUM CHLORIDE FLISH SYRINGE Am USA | NGT |
| Jan 30, 2012 | K113555 | AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGE Am USA | NGT |
| Jul 29, 2011 | K103740 | SODIUM CHLORIDE INJECTION, 0.9%, USP 5 ML, 10 ML AMPULE Spectra Medical Devices, Inc. | NGT |
| Jul 14, 2011 | K111034 | AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGE Am USA | NGT |
| Feb 10, 2011 | K101270 | SWABFLSUH (3ML, 5ML, 10ML) MODEL 10331, 10351, 10311 Excelsior Medical Corp., CA | NGT |
| Apr 23, 2010 | K090882 | FLUSH SYRINGE FILLED WITH 0.9% SODIUM CHLORIDE Hospira, Inc. | NGT |
| Jan 28, 2010 | K091583 | MEDEFIL'S NORMAL SALINE I.V. FLUSH SYRINGE Medefil, Inc. | NGT |
| Mar 20, 2009 | K082689 | STERILE SODIUM CHLORIDE 0.9% FLUSH, 5ML, 10ML, AMPULE Spectra Medical Devices, Inc. | NGT |
| Dec 18, 2008 | K082837 | STERILE FIELD SALINE PRE-FILLED SYRINGE(S) Excelsior Medical Corp. | NGT |
| Apr 28, 2006 | K060339 | KENDALL MONOJECT PRE-FILL ADVANCED 0.9%SODIUM CHLORIDE FLUSH SYRINGES FOR STERILE DELIVERY Tyco Healthcare/Kendall | NGT |
| Aug 26, 2004 | K042061 | 0.9% SODIUM CHLORIDE INJECTION, USP BD POSTFLUSH SF FLUSH SYRINGE Becton Dickinson | NGT |
| Jun 30, 2004 | K032438 | MODIFICATION TO: MONOJET PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE, MONOJET PREFILL HEPRIN LOCK FLUSH SYRINGE Tyco Healthcare | NGT |
| Jun 24, 2002 | K020996 | 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. | NGT |
| Jun 20, 2002 | K020999 | 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. | NGT |
| Oct 15, 2001 | K011283 | MONOJECT PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE The Kendall Company | NGT |
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