Panels › General Hospital › Product code FMI · Class 2
Needle, Hypodermic, Single Lumen
Regulation 880.5570
13510(k)s in 12 months (694 all time)
3recalls in 12 months (311 all time)
283recalls that name a 510(k)
Top companies in FMI
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 30, 2019 | Cardinal Health 200, LLC Monoject Standard Hypodermic Needle, 14 G x 1-1/2"
Item code: 8881200011 Completed |
FMI | K854547 |
| Feb 11, 2019 | Smiths Medical ASD Inc. Smith Medical JELCO Hypodermic Needle-Pro EDGE Safety Device Safety Device Rx Only Sterile
Product Usage:
Is a disposable, single use device intended for injection or aspiration of fluids using a Lue Terminated |
FMI | K041399 |
| Feb 8, 2019 | Terumo Medical Corporation Terumo Needle, 30G x 1/2", Product Code NN3013R Terminated |
FMI | K121607 |
| Feb 8, 2019 | Terumo Medical Corporation Terumo Needle, 23G x 1", Product Code NN2325R Terminated |
FMI | K121607 |
| Feb 8, 2019 | Terumo Medical Corporation Terumo Needle, 18G x 1", Product Code NN1825R Terminated |
FMI | K121607 |
| Feb 8, 2019 | Terumo Medical Corporation Terumo Sur-vet Needle, 25G x 5/8", Product Code 100280 Terminated |
FMI | K121607 |
| Feb 8, 2019 | Terumo Medical Corporation Terumo Sur-vet Needle, 22G x 3/4", Product Code 100279 Terminated |
FMI | K121607 |
| Feb 8, 2019 | Terumo Medical Corporation Terumo Sur-vet Needle, 25G x 5/8", Product Code 100220 Terminated |
FMI | K121607 |
| Feb 8, 2019 | Terumo Medical Corporation Terumo Sur-vet Needle, 22G x 3/4", Product Code 100215 Terminated |
FMI | K121607 |
| Feb 8, 2019 | Terumo Medical Corporation Terumo Sur-vet Needle, 22G x 1", Product Code 100211 Terminated |
FMI | K121607 |
| Feb 8, 2019 | Terumo Medical Corporation Terumo Sur-vet Needle, 20G x 1", Product Code 100204 Terminated |
FMI | K121607 |
| Feb 1, 2019 | Becton Dickinson & Company 3mL Safety-Lok Syringe, Catalog Number 309606, UDI 30382903096061 Terminated |
FMI | K944757 |
| Apr 11, 2018 | Arrow International Inc Echogenic Needle; Product codes: PN-00215-E and PN-00217-E Terminated |
FMI | K071998 |
| Apr 11, 2018 | Arrow International Inc Echogenic Introducer Needle; Product Code: AN-04318 Terminated |
FMI | K071998 |
| Apr 6, 2018 | MHC Medical Products LLC EasyTouch (ET) Insulin Syringe 29G 0.5ml " (Item 829555)
Product Usage:
INTENDED FOR INJECTION OF U100 INSULIN ONLY Open, Classified |
FMI | K112789 |
| Apr 6, 2018 | MHC Medical Products LLC EasyTouch (ET) Insulin Syringe 29G 1ml " (Item 829155)
Product Usage:
INTENDED FOR INJECTION OF U100 INSULIN ONLY Open, Classified |
FMI | K112789 |
| Nov 6, 2017 | Owen Mumford USA, Inc. Unifine Pentips 5mm x 31G pen needles, packaged in 30 ct pen needles.
Product Usage:
Sterile, non-toxic, non-pyrogenic, single use pen needles for the subcutaneous injection of drugs from pen inject Terminated |
FMI | K152339 |
| Nov 6, 2017 | Owen Mumford USA, Inc. Unifine Pentips 5mm x 31G pen needles, packaged in 100 ct pen needles.
Product Usage:
Sterile, non-toxic, non-pyrogenic, single use pen needles for the subcutaneous injection of drugs from pen inject Terminated |
FMI | K152339 |
| Sep 22, 2017 | Guangzhou Improve Medical Instruments Co., Ltd. Prevent G Safety Winged Blood Collection Set Glide - Rx Only -Sterile/EO - Product Usage: The IMPROSAFE Blood Collection Set is single-use, sterile, winged needle bonded to a flexible tubing with luer Open, Classified |
FMI | K123987 |
| Sep 22, 2017 | Guangzhou Improve Medical Instruments Co., Ltd. Prevent G Safety Winged Blood Collection Set Glide - Sterile/EO Open, Classified |
FMI | K123987 |
| Jul 24, 2017 | Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. 19Ga x 1 Huber Needle Set. Product Code: MBS-1910. Terminated |
FMI | K873957 |
| Jul 10, 2017 | Arrow International Inc Radial Artery Catheterization Set, 1) NA-04550-1A & 2) NA-04550-X1A, device permits access to the peripheral arterial circulation or to other small vessels. Terminated |
FMI | K810675 |
| Jul 5, 2017 | Centurion Medical Products Corporation SafetyGlide Needle, 22GA 1-1/2in, Catalog n. 301701, manufactured by BD, sold in
Centurion Convenience Kits.
Centurion component code BD17O1NS. Terminated |
FMI | K951254 |
| Jun 23, 2017 | International Medsurg Connection, Inc. Hypodermic Needle, 30 G X 1.0 in DISP HYPO, 100 per box, 50 boxes/case, 5,000/case
The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the di Terminated |
FMI | K102584 |
| Jun 23, 2017 | International Medsurg Connection, Inc. Hypodermic Needle, 30 G X 0.5 in REG BEVEL, 100 per box, 50 boxes/case, 5,000/case
The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the di Terminated |
FMI | K102584 |
| Jun 23, 2017 | International Medsurg Connection, Inc. Hypodermic Needle, 27 G X 1.5 in HYPODERMIC, 100 per box, 50 boxes/case, 5,000/case
The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the d Terminated |
FMI | K102584 |
| Jun 23, 2017 | International Medsurg Connection, Inc. Hypodermic Needle, 27 G X 1.0 in DISP HYPO, 100 per box, 50 boxes/case, 5,000/case
The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the di Terminated |
FMI | K102584 |
| Jun 23, 2017 | International Medsurg Connection, Inc. Hypodermic Needle, 27 G X 0.5 in REG BEVEL, 100 per box, 50 boxes/case, 5,000/case
The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the di Terminated |
FMI | K102584 |
| Jun 23, 2017 | International Medsurg Connection, Inc. Hypodermic Needle, 25 G X 5/8 in REG BEVEL, 100 per box, 50 boxes/case, 5,000/case
The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the di Terminated |
FMI | K102584 |
| Jun 23, 2017 | International Medsurg Connection, Inc. Hypodermic Needle, 25 G X 1.5 in REG BEVEL, 100 per box, 50 boxes/case, 5,000/case
The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the di Terminated |
FMI | K102584 |
| Jun 23, 2017 | International Medsurg Connection, Inc. Hypodermic Needle, 25 G X 1.0 in REG BEVEL, 100 per box, 50 boxes/case, 5,000/case
The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the di Terminated |
FMI | K102584 |
| Jun 23, 2017 | International Medsurg Connection, Inc. Hypodermic Needle, 23 G X 1.0 in REG BEVEL, 100 per box, 50 boxes/case, 5,000/case
The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the di Terminated |
FMI | K102584 |
| Jun 23, 2017 | International Medsurg Connection, Inc. Hypodermic Needle, 22 G X 1.5 in REG BEVEL, 100 per box, 50 boxes/case, 5,000/case
The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the di Terminated |
FMI | K102584 |
| Jun 23, 2017 | International Medsurg Connection, Inc. Hypodermic Needle, 22 G X 1.0 in REG BEVEL, 100 per box, 50 boxes/case, 5,000/case
The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the di Terminated |
FMI | K102584 |
| Jun 23, 2017 | International Medsurg Connection, Inc. Hypodermic Needle, 21 G X 1.5 in YALE DISP, 100 per box, 50 boxes/case, 5,000/case
The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the di Terminated |
FMI | K102584 |
| Jun 23, 2017 | International Medsurg Connection, Inc. Hypodermic Needle, 21 G X 1.0 in REG BEVEL, 100 per box, 50 boxes/case, 5,000/case
The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the di Terminated |
FMI | K102584 |
| Jun 23, 2017 | International Medsurg Connection, Inc. Hypodermic Needle, 20 G X 1.5 in BD YALE DISP RG, 100 per box, 50 boxes/case, 5,000/case
The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in Terminated |
FMI | K102584 |
| Jun 23, 2017 | International Medsurg Connection, Inc. Hypodermic Needle, 20 G X 1.0 in REG BEVEL, 100 per box, 50 boxes/case, 5,000/case
The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the di Terminated |
FMI | K102584 |
| Jun 23, 2017 | International Medsurg Connection, Inc. Hypodermic Needle, 19 G X 1.5 in BD YALE DISP RG, 100 per box, 50 boxes/case, 5,000/case
The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in Terminated |
FMI | K102584 |
| Jun 23, 2017 | International Medsurg Connection, Inc. Hypodermic Needle, 19 G X 1.0 in BD YALE DISP RG, 100 per box, 50 boxes/case, 5,000/case
The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in Terminated |
FMI | K102584 |
| Jun 23, 2017 | International Medsurg Connection, Inc. Hypodermic Needle, 18 G X 1.5 in REG BEVEL, 100 per box, 50 boxes/case, 5,000/case
The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the di Terminated |
FMI | K102584 |
| Jun 23, 2017 | International Medsurg Connection, Inc. Hypodermic Needle, 18 G X 1 in DSP REG BEVEL, 100 per box, 50 boxes/case, 5,000/case
The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the Terminated |
FMI | K102584 |
| Jun 23, 2017 | International Medsurg Connection, Inc. Hypodermic Needle, 16G X 1.5in DSP REG BEVEL, 100 per box, 50 boxes/case, 5,000/case
The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the Terminated |
FMI | K102584 |
| Jun 21, 2017 | B. Braun Medical, Inc. Contiplex Nerve Block Tray. Product Catalog Number: 570205.
Local anesthesia of the skin prior to insertion of the regional anesthesia needle. Terminated |
FMI | None listed |
| Jun 21, 2017 | B. Braun Medical, Inc. Pain Management Tray. Product Catalog Number: 560602.
Local anesthesia of the skin prior to insertion of the regional anesthesia needle. Terminated |
FMI | None listed |
| Jun 21, 2017 | B. Braun Medical, Inc. Customer Epidural Anesthesia Tray. Product Catalog Number: 555234.
Local anesthesia of the skin prior to insertion of the regional anesthesia needle. Terminated |
FMI | None listed |
| Jun 21, 2017 | B. Braun Medical, Inc. Spinal & Epidural Anesthesia Tray. Product Catalog Number: 555172.
Local anesthesia of the skin prior to insertion of the regional anesthesia needle. Terminated |
FMI | None listed |
| Jun 21, 2017 | B. Braun Medical, Inc. PENCAN Spinal Anesthesia Tray. Product Catalog Number: 560590.
Local anesthesia of the skin prior to insertion of the regional anesthesia needle. Terminated |
FMI | None listed |
| Jun 21, 2017 | B. Braun Medical, Inc. Perifix FX Epidural Anesthesia Tray. Product Catalog Numbers: 551993, 552051, 552083, 552119, 555569.
Local anesthesia of the skin prior to insertion of the regional anesthesia needle. Terminated |
FMI | None listed |
| Jun 21, 2017 | B. Braun Medical, Inc. Perifix Epidural AnesthesiaTray. Product Catalog Numbers: 551879, 551994, 552024.
Local anesthesia of the skin prior to insertion of the regional anesthesia needle. Terminated |
FMI | None listed |
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