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)
Jun 21, 2017B. Braun Medical, Inc.
Pencan Spinal Needle Tray. Product Catalog Number: 333865. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
Terminated
FMINone listed
Jun 21, 2017B. Braun Medical, Inc.
Perifix Single Dose Epidural Anesthesia Tray. Product Catalog Number: 332252. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
Terminated
FMINone listed
Jun 21, 2017B. Braun Medical, Inc.
Perifix Continuous Epidural Anesthesia Tray. Product Catalog Numbers: 332075, 332266. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
Terminated
FMINone listed
Jun 13, 2017Becton Dickinson & Company
BD Needle 22GA 1-1/2in SafetyGlide(TM) Non Sterile, Bulk, REF 301701 The BD SafetyGlide(TM) needle is intended to be used for general purpose injection, aspiration of fluids from parts of the body
Terminated
FMIK951254
May 31, 2017Becton Dickinson & Company
BD Precision Glide Needle 18G x 1 RB, Catalog 305195 Product Usage: These needles are intended for general purpose fluid injection/aspiration, infusion, venipuncture to obtain blood collection and i
Terminated
FMIK021475
Apr 4, 2017Smiths Medical ASD Inc.
Jelco, Hypodermic needle Pro needles 19G X1 1/2" 800/CA Model No. EL 1915 & 19G X 2" 600/CA Model No. SB 5021, Rx Only, Sterile EO.
Terminated
FMIK923127
Apr 4, 2017Teleflex Medical
Arrow EZ-IO Needle Set 45 mm 15 ga, Ref 9079.
Terminated
FMIK091140
Dec 20, 2016Becton Dickinson & Company
Eclipse Hypodermic Needle
Terminated
FMIK161170
Oct 19, 2016Guangzhou Improve Medical Instruments Co., Ltd.
Improve Blood Collection Sets with Multiple Sample Luer Adapter - Sterile/EO Product Usage: The Blood Collection Set are single-use, sterile, winged needle bonded to a flexible tubing with luer adap
Open, Classified
FMIK123987
Sep 22, 2016Global Healthcare Inc
MED 5223 - VacuFlow Safe, Multi-Sample Blood Collection Set With Luer Adapter Tube 12", Sterile, Rx only, Distributed by Tanner Scientific, Sarasota, FGL 34243 Made in China.
Terminated
FMIK000714
Sep 16, 2016Becton Dickinson & Company
BD SafetyGlide" Injection Needle Catalog #305917 The SafetyGlide " needle is intended to be used for general purpose injection, aspiration of fluids from parts of the body below the surface of the s
Terminated
FMIK951254
Aug 18, 2016Waismed Ltd
NIO-A / NIO-P is an instant IO access device comprises housing with spring load mechanism that injects a trocar needle into the bone marrow of a patient and allows connection of syringe or IV administ
Terminated
FMIK160805
Dec 17, 2015Myco Medical Supplies Inc
Unolok Blunt Fill Needle 18G x 1.5" Red, Sterile, Single use, Non-injectable needle, Single use, non-injection needle
Terminated
FMIK945225
Jun 15, 2015Vidacare Corporation
T.A.L.O.N (Tactically Advanced Lifesaving Intraosseous Needle) 15G x 38.5 mm 10 NEEDLE SET STERILE EO Single Use Rx only Vidacare Corporation
Terminated
FMIK120661
Dec 30, 2014Smiths Medical ASD, Inc.
Hypodermic Needle Pro Edge" Safety Device with Syringe 20G x1 5mL Luer lock syringe; Reorder Number: 452010 Product Usage: The Needle Pro Edge Safety Hypodermic Needle is intended for injection or as
Completed
FMIK041399
Dec 30, 2014Smiths Medical ASD, Inc.
Hypodermic Needle Pro Edge" Safety Device with Syringe 20G x1 10mL Luer lock syringe; Reorder Number: 4102010 Product Usage: The Needle Pro Edge Safety Hypodermic Needle is intended for injection or
Completed
FMIK041399
Dec 30, 2014Smiths Medical ASD, Inc.
Hypodermic Needle Pro Edge" Safety Device 20G x1; Reorder Number: 402010 Product Usage: The Needle Pro Edge Safety Hypodermic Needle is intended for injection or aspiration of fluids utilizing a luer
Completed
FMIK041399
Sep 22, 2014Vidacare Corporation
EZ-IO 45mm (40kg & up) Needle Set, part number 9079-VC-005; lot code 3606455
Terminated
FMIK052408
Feb 15, 2013Greiner Bio-One North America, Inc.
VACUETTE Safety Blood Collection Set + Luer Adapter, 23x12" Safety Blood Collect LA Product, Item number 450096. Usage: The Safety Blood Collection Set is used in routine venipuncture procedures.
Terminated
FMIK011786
Jul 3, 2012Greiner Bio-One North America, Inc.
Vacuette Quickshield Complete Plus, 21G x 1 (0.8 x 25 mm), Greiner bio-one. The Quick shield Complete Plus is intended to be used only with Vacuette Blood collection Tubes as a system in routine veni
Terminated
FMIK072320
May 1, 2012Churchill Medical Systems, Inc.
Churchill Medical Systems Winged Infusion Set, 22Ga, 1", Latex-Free Winged Infusion Set Product Code: MBS-2210 Huber type needle set used for the infusion of medical fluids into implantable ports.
Terminated
FMIK873957
Feb 13, 2012Becton Dickinson & Company
BD 30G1/2" Precision Glide" Needle Needles are used for aspiration and injection of medications
Terminated
FMIK021475
Dec 16, 2011Merz Aesthetics, Inc.
MERZ AESTHETICS, 27G X 1.0 " (25MM) Cannula, Sterile R, QTY 20, Model 9015M1X20, Distributed by Merz Aesthetics, In., Manufactured by TSK Laboratory. The intended use of the Cannula is the injection
Terminated
FMIK970370
Nov 9, 2011Greiner Bio-One North America, Inc.
Quick Shield with Snappy Safety Holder, Greiner bio-one. The VACUETTE QUICKSHIELD with SNAPPY Tube Holder is intended to be used only with the VACUETTE Blood Collection Needles and VACUETTE Blood Col
Terminated
FMIK102774
Aug 8, 2011Greiner Bio-One North America, Inc.
HOLDEX Single-Use Holder PP closed pack. Greiner Bio-One Austria Gmbh. A sterile single-use disposable holder with an off-center female luer at the top of the holder and epoxy bonded stainless stee
Terminated
FMIK980768
Jul 13, 2011Terumo Medical Corporation
Terumo(tm) Hypodermic Needle, sterile, individually packaged into a "blister-pack" flexible plastic bottom-web thermo-formed to create a pocket, heat-sealed with paper top-web,1,000 needles per case.
Terminated
FMIK771203
Jun 28, 2011Pyng Medical Corporation
The product is the "FASTx Sternal Intraosseous Device". The expiration date for the recalled products is end of June, 2012. The device is used to insert an infusion tube into the manubrium (upper por
Terminated
FMIK100124
May 13, 2011Becton Dickinson & Company
BD Nokor Admix Needle 16 G x 1 TW (1.6mm x 25mm) REF 305216 Sterile BD, Franklin Lakes, NJ MADE IN USA For use in aspiration of medications, typically in the pharmacy setting.
Terminated
FMINone listed
Dec 27, 2010Becton Dickinson & Company
BD Vacutainer Push Button collection Set; Non-Pyrogenic, Sterile, Rx only; 23 G x 3/4 x 12" (0.6 x 19 mm x 305 mm) Becton Dickinson & Co., Franklin Lakes, NJ, USA Intended use: Blood collection
Terminated
FMIK011984
Sep 29, 2010Multi-Med, Inc.
ALLMED Huber Needles 22ga x .75 Straight Hub Needle - Bulk, Non-Sterile Model # M2275HS-NS Reorder # 55-2235 Intended to be used to inject fluids into, withdraw fluids from inside the vascular space
Terminated
FMIK891919
Sep 29, 2010Multi-Med, Inc.
ALLMED Huber Needles 22ga x 1" Straight Hub Needle - Bulk, Non-Sterile Model # M221HS-NS Reorder # 55-2230 Intended to be used to inject fluids into, withdraw fluids from inside the vascular space th
Terminated
FMIK891919
Sep 29, 2010Multi-Med, Inc.
Marquette Medical Huber Trap-A Safety Huber Needle 19ga x .75' Winged Administration Set Model # MW193 Intended to be used to inject fluids into, withdraw fluids from inside the vascular space throug
Terminated
FMIK891919
Sep 29, 2010Multi-Med, Inc.
Marquette Medical Huber Trap-A Safety Huber Needle 22ga x .75" Huber Trap with Needleless Y Model # MW223Y-HT Intended to be used to inject fluids into, withdraw fluids from inside the vascular space
Terminated
FMIK891919
Sep 29, 2010Multi-Med, Inc.
Marquette Medical Huber Trap-A Safety Huber Needle 22ga x .75" Huber Trap Model # MW223-HT Intended to be used to inject fluids into, withdraw fluids from inside the vascular space through a subcutan
Terminated
FMIK891919
Sep 29, 2010Multi-Med, Inc.
Marquette Medical Huber Trap-A Safety Huber Needle 20ga x .75" Huber Trap with Needleless Y Model # MW203Y-HT Intended to be used to inject fluids into, withdraw fluids from inside the vascular space
Terminated
FMIK891919
Sep 29, 2010Multi-Med, Inc.
Marquette Medical Huber Trap-A Safety Huber Needle 20ga x .75" Huber Trap Model # MW203-HT Intended to be used to inject fluids into, withdraw fluids from inside the vascular space through a subcutan
Terminated
FMIK891919
Sep 29, 2010Multi-Med, Inc.
Marquette Medical Huber Trap-A Safety Huber Needle 20ga x 1" Huber Trap with Needleless Y Model # MW201Y-HT Intended to be used to inject fluids into, withdraw fluids from inside the vascular space t
Terminated
FMIK891919
Sep 29, 2010Multi-Med, Inc.
Marquette Medical Huber Trap-A Safety Huber Needle 19ga x 1" Huber Trap with Needleless Y Model # MW191Y-HT Intended to be used to inject fluids into, withdraw fluids from inside the vascular space t
Terminated
FMIK891919
Sep 29, 2010Multi-Med, Inc.
Marquette Medical Huber Trap-A Safety Huber Needle 22ga x 1 Winged Administration Set w/Y Site Model # MW221Y Intended to be used to inject fluids into, withdraw fluids from inside the vascular space
Terminated
FMIK891919
Sep 29, 2010Multi-Med, Inc.
Marquette Medical Huber Trap-A Safety Huber Needle 22ga x 1 Standard Bore Winged Administration Set Model # MWS221 Intended to be used to inject fluids into, withdraw fluids from inside the vascular
Terminated
FMIK891919
Sep 29, 2010Multi-Med, Inc.
Marquette Medical Huber Trap-A Safety Huber Needle 22ga x .75" Winged Administration Set w/Y Site Model # MW223Y Intended to be used to inject fluids into, withdraw fluids from inside the vascular sp
Terminated
FMIK891919
Sep 29, 2010Multi-Med, Inc.
Marquette Medical Huber Trap-A Safety Huber Needle 22ga x .75" Winged Administration Set Model # MW223 Intended to be used to inject fluids into, withdraw fluids from inside the vascular space throug
Terminated
FMIK891919
Sep 29, 2010Multi-Med, Inc.
Marquette Medical Huber Trap-A Safety Huber Needle 22ga x 1" Winged Administration Set Model # MW221 Intended to be used to inject fluids into, withdraw fluids from inside the vascular space through
Terminated
FMIK891919
Sep 29, 2010Multi-Med, Inc.
Marquette Medical Huber Trap-A Safety Huber Needle 22ga x .75" Standard Bore Winged Administration Set Model # MWS223 Intended to be used to inject fluids into, withdraw fluids from inside the vascul
Terminated
FMIK891919
Sep 29, 2010Multi-Med, Inc.
Marquette Medical Huber Trap-A Safety Huber Needle 20ga x 1" Standard Bore Winged Administration Set Model # MWS201 Intended to be used to inject fluids into, withdraw fluids from inside the vascular
Terminated
FMIK891919
Sep 29, 2010Multi-Med, Inc.
Marquette Medical Huber Trap-A Safety Huber Needle 20ga x 1" Winged Administration Set Model # MW201 Intended to be used to inject fluids into, withdraw fluids from inside the vascular space through
Terminated
FMIK891919
Sep 29, 2010Multi-Med, Inc.
Marquette Medical Huber Trap-A Safety Huber Needle 20ga x .75" Winged Administration Set w/Y Site Model # MW203Y Intended to be used to inject fluids into, withdraw fluids from inside the vascular sp
Terminated
FMIK891919
Sep 29, 2010Multi-Med, Inc.
Marquette Medical Huber Trap-A Safety Huber Needle 20ga x 1" Winged Administration Set w/Y Site Model # MW201Y Intended to be used to inject fluids into, withdraw fluids from inside the vascular spac
Terminated
FMIK891919
Sep 29, 2010Multi-Med, Inc.
Marquette Medical Huber Trap-A Safety Huber Needle 19ga x 1" Winged Administration Set Model # MW191 Intended to be used to inject fluids into, withdraw fluids from inside the vascular space through
Terminated
FMIK891919
Sep 29, 2010Multi-Med, Inc.
Marquette Medical Huber Trap-A Safety Huber Needle 20ga x .75" Winged Administration Set w/Y Site Model # MWS203 Intended to be used to inject fluids into, withdraw fluids from inside the vascular sp
Terminated
FMIK891919

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