ClearanceBrief
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)
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Top companies in FMI

DateFirm and productCodeLinked 510(k)
Apr 30, 2019Cardinal Health 200, LLC
Monoject Standard Hypodermic Needle, 14 G x 1-1/2" Item code: 8881200011
Completed
FMIK854547
Feb 11, 2019Smiths 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
FMIK041399
Feb 8, 2019Terumo Medical Corporation
Terumo Needle, 30G x 1/2", Product Code NN3013R
Terminated
FMIK121607
Feb 8, 2019Terumo Medical Corporation
Terumo Needle, 23G x 1", Product Code NN2325R
Terminated
FMIK121607
Feb 8, 2019Terumo Medical Corporation
Terumo Needle, 18G x 1", Product Code NN1825R
Terminated
FMIK121607
Feb 8, 2019Terumo Medical Corporation
Terumo Sur-vet Needle, 25G x 5/8", Product Code 100280
Terminated
FMIK121607
Feb 8, 2019Terumo Medical Corporation
Terumo Sur-vet Needle, 22G x 3/4", Product Code 100279
Terminated
FMIK121607
Feb 8, 2019Terumo Medical Corporation
Terumo Sur-vet Needle, 25G x 5/8", Product Code 100220
Terminated
FMIK121607
Feb 8, 2019Terumo Medical Corporation
Terumo Sur-vet Needle, 22G x 3/4", Product Code 100215
Terminated
FMIK121607
Feb 8, 2019Terumo Medical Corporation
Terumo Sur-vet Needle, 22G x 1", Product Code 100211
Terminated
FMIK121607
Feb 8, 2019Terumo Medical Corporation
Terumo Sur-vet Needle, 20G x 1", Product Code 100204
Terminated
FMIK121607
Feb 1, 2019Becton Dickinson & Company
3mL Safety-Lok Syringe, Catalog Number 309606, UDI 30382903096061
Terminated
FMIK944757
Apr 11, 2018Arrow International Inc
Echogenic Needle; Product codes: PN-00215-E and PN-00217-E
Terminated
FMIK071998
Apr 11, 2018Arrow International Inc
Echogenic Introducer Needle; Product Code: AN-04318
Terminated
FMIK071998
Apr 6, 2018MHC Medical Products LLC
EasyTouch (ET) Insulin Syringe 29G 0.5ml " (Item 829555) Product Usage: INTENDED FOR INJECTION OF U100 INSULIN ONLY
Open, Classified
FMIK112789
Apr 6, 2018MHC Medical Products LLC
EasyTouch (ET) Insulin Syringe 29G 1ml " (Item 829155) Product Usage: INTENDED FOR INJECTION OF U100 INSULIN ONLY
Open, Classified
FMIK112789
Nov 6, 2017Owen 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
FMIK152339
Nov 6, 2017Owen 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
FMIK152339
Sep 22, 2017Guangzhou 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
FMIK123987
Sep 22, 2017Guangzhou Improve Medical Instruments Co., Ltd.
Prevent G Safety Winged Blood Collection Set Glide - Sterile/EO
Open, Classified
FMIK123987
Jul 24, 2017Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
19Ga x 1 Huber Needle Set. Product Code: MBS-1910.
Terminated
FMIK873957
Jul 10, 2017Arrow 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
FMIK810675
Jul 5, 2017Centurion 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
FMIK951254
Jun 23, 2017International 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
FMIK102584
Jun 23, 2017International 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
FMIK102584
Jun 23, 2017International 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
FMIK102584
Jun 23, 2017International 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
FMIK102584
Jun 23, 2017International 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
FMIK102584
Jun 23, 2017International 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
FMIK102584
Jun 23, 2017International 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
FMIK102584
Jun 23, 2017International 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
FMIK102584
Jun 23, 2017International 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
FMIK102584
Jun 23, 2017International 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
FMIK102584
Jun 23, 2017International 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
FMIK102584
Jun 23, 2017International 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
FMIK102584
Jun 23, 2017International 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
FMIK102584
Jun 23, 2017International 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
FMIK102584
Jun 23, 2017International 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
FMIK102584
Jun 23, 2017International 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
FMIK102584
Jun 23, 2017International 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
FMIK102584
Jun 23, 2017International 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
FMIK102584
Jun 23, 2017International 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
FMIK102584
Jun 23, 2017International 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
FMIK102584
Jun 21, 2017B. 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
FMINone listed
Jun 21, 2017B. Braun Medical, Inc.
Pain Management Tray. Product Catalog Number: 560602. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
Terminated
FMINone listed
Jun 21, 2017B. 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
FMINone listed
Jun 21, 2017B. 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
FMINone listed
Jun 21, 2017B. 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
FMINone listed
Jun 21, 2017B. 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
FMINone listed
Jun 21, 2017B. 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
FMINone listed

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