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) |
|---|---|---|---|
| Jun 21, 2017 | B. 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 |
FMI | None listed |
| Jun 21, 2017 | B. 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 |
FMI | None listed |
| Jun 21, 2017 | B. 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 |
FMI | None listed |
| Jun 13, 2017 | Becton 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 |
FMI | K951254 |
| May 31, 2017 | Becton 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 |
FMI | K021475 |
| Apr 4, 2017 | Smiths 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 |
FMI | K923127 |
| Apr 4, 2017 | Teleflex Medical Arrow EZ-IO Needle Set 45 mm 15 ga, Ref 9079. Terminated |
FMI | K091140 |
| Dec 20, 2016 | Becton Dickinson & Company Eclipse Hypodermic Needle Terminated |
FMI | K161170 |
| Oct 19, 2016 | Guangzhou 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 |
FMI | K123987 |
| Sep 22, 2016 | Global 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 |
FMI | K000714 |
| Sep 16, 2016 | Becton 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 |
FMI | K951254 |
| Aug 18, 2016 | Waismed 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 |
FMI | K160805 |
| Dec 17, 2015 | Myco Medical Supplies Inc Unolok Blunt Fill Needle 18G x 1.5" Red, Sterile, Single use, Non-injectable needle,
Single use, non-injection needle Terminated |
FMI | K945225 |
| Jun 15, 2015 | Vidacare 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 |
FMI | K120661 |
| Dec 30, 2014 | Smiths 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 |
FMI | K041399 |
| Dec 30, 2014 | Smiths 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 |
FMI | K041399 |
| Dec 30, 2014 | Smiths 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 |
FMI | K041399 |
| Sep 22, 2014 | Vidacare Corporation EZ-IO 45mm (40kg & up) Needle Set, part number 9079-VC-005; lot code 3606455 Terminated |
FMI | K052408 |
| Feb 15, 2013 | Greiner 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 |
FMI | K011786 |
| Jul 3, 2012 | Greiner 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 |
FMI | K072320 |
| May 1, 2012 | Churchill 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 |
FMI | K873957 |
| Feb 13, 2012 | Becton Dickinson & Company BD 30G1/2" Precision Glide" Needle
Needles are used for aspiration and injection of medications Terminated |
FMI | K021475 |
| Dec 16, 2011 | Merz 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 |
FMI | K970370 |
| Nov 9, 2011 | Greiner 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 |
FMI | K102774 |
| Aug 8, 2011 | Greiner 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 |
FMI | K980768 |
| Jul 13, 2011 | Terumo 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 |
FMI | K771203 |
| Jun 28, 2011 | Pyng 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 |
FMI | K100124 |
| May 13, 2011 | Becton 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 |
FMI | None listed |
| Dec 27, 2010 | Becton 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 |
FMI | K011984 |
| Sep 29, 2010 | Multi-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 |
FMI | K891919 |
| Sep 29, 2010 | Multi-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 |
FMI | K891919 |
| Sep 29, 2010 | Multi-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 |
FMI | K891919 |
| Sep 29, 2010 | Multi-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 |
FMI | K891919 |
| Sep 29, 2010 | Multi-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 |
FMI | K891919 |
| Sep 29, 2010 | Multi-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 |
FMI | K891919 |
| Sep 29, 2010 | Multi-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 |
FMI | K891919 |
| Sep 29, 2010 | Multi-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 |
FMI | K891919 |
| Sep 29, 2010 | Multi-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 |
FMI | K891919 |
| Sep 29, 2010 | Multi-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 |
FMI | K891919 |
| Sep 29, 2010 | Multi-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 |
FMI | K891919 |
| Sep 29, 2010 | Multi-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 |
FMI | K891919 |
| Sep 29, 2010 | Multi-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 |
FMI | K891919 |
| Sep 29, 2010 | Multi-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 |
FMI | K891919 |
| Sep 29, 2010 | Multi-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 |
FMI | K891919 |
| Sep 29, 2010 | Multi-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 |
FMI | K891919 |
| Sep 29, 2010 | Multi-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 |
FMI | K891919 |
| Sep 29, 2010 | Multi-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 |
FMI | K891919 |
| Sep 29, 2010 | Multi-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 |
FMI | K891919 |
| Sep 29, 2010 | Multi-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 |
FMI | K891919 |
| Sep 29, 2010 | Multi-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 |
FMI | K891919 |
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