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) |
|---|---|---|---|
| Sep 29, 2010 | Multi-Med, Inc. All Med Medical 19ga x .75" Winged Administration Set
Model # M1975
Reorder # 50-1921 Terminated |
FMI | K891919 |
| Sep 29, 2010 | Multi-Med, Inc. All Med Medical 19ga x .50" Winged Administration Set w/Y Site
Model # M195Y
Reorder # 50-1912 Terminated |
FMI | K891919 |
| Jul 13, 2010 | Medical Device Technologies, Inc. Angiotech Galactography Kit.
Galactography Kit 30ga with Straight Cannula and Galactography Kit 30ga with Curved Cannula. STERILE. Product Number: DGK002SX, DGK002X. 510k K980227. Qty Dist. - 2 Terminated |
FMI | None listed |
| Jul 2, 2010 | Multi-Med, Inc. 22ga x 1" Right Angle Huber Needle
This product is a small gauge needle intended for single use hypodermic access to implanted ports. Terminated |
FMI | K891919 |
| Jul 2, 2010 | Multi-Med, Inc. 22ga x 1" Straight Huber Needle
This product is a small gauge needle intended for single use hypodermic access to implanted ports. Terminated |
FMI | K891919 |
| Mar 15, 2010 | Centurion Medical Products Centurion Healthcare Products Pump Fill Kit DT10175. CONTENTS: 1 CSR WRAP, 2 GLOVES, 1 FENESTRATED DRAPE, 1 EXTENSION LINE Approx. Priming Vol.: 0.3mL, 1 SYRINGE, 1 Exel Huber NEEDLE, 1 ChloraPrep(R) Terminated |
FMI | None listed |
| Jan 22, 2010 | Exelint International Co. Exel Huber Needles (Right angle and Straight Models with Catalog Numbers: 26901CE, 26902CE, 26903CE, 26904CE, 26905CE, 26906CE, 26907CE, 26908CE, 26909CE, 26910CE, 26911CE, 26921CE, 26922CE, 26923CE, Terminated |
FMI | K895769 |
| Jul 24, 2009 | Stat Medical Devices, Inc. Stat (TM) Super-Fine (TM) Pen Needles and Allison Medical, Inc. Sure Comfort Pen Needles with Silicone Tip, for human use with insulin pen injector device to administer insulin subcutaneously. Terminated |
FMI | None listed |
| Nov 5, 2008 | Covidien LP ReliOn Insulin syringes - 1cc, 31 G
Distributed by: Can-Am Care, Corp., Alpharetta, GA Terminated |
FMI | K033373 |
| Sep 30, 2008 | Greiner Bio-One North America, Inc. Plastic Cannula Holdex Tube Holder, Item number: 450216. It is intended for use in routine specimen withdrawal from specimen collection bags or bottles through needleless cannula ports. Terminated |
FMI | K980768 |
| Sep 11, 2008 | Greiner Bio-One North America, Inc. Vacuette, Plastic Cannula HOLDEX, Ref 450216, Single packed, sterile, single use disposable tube holder with off center plastic cannula at the top and a stainless steel needle on the underside of the Terminated |
FMI | K980768 |
| Feb 12, 2008 | Popper & Sons Inc PERFEKTUM TOOMEY EVACUATING SYRINGES, REF/Part # 5047, DESCRIPTION: 30CC LOCK TIP, RX ONLY, NON-STERILE. Manufactured By: Popper & Sons, Inc. New Hyde Park, NY. 11040. Terminated |
FMI | None listed |
| Sep 20, 2007 | Becton Dickinson & Company ReliOn 0.5cc 30 g x 8mm Blister Pak U-100 syringe
30 gauge x 5/16" length, for subcutaneous injection of insulin. Terminated |
FMI | K024112 |
| May 24, 2007 | Becton Dickinson & Company BD AutoShield Pen Needle (Re order Number : 329300) Terminated |
FMI | K060007 |
| Sep 9, 2006 | Becton Dickinson & Company BD Vacutainer Blood Collection Assembly with BD Blunt Plastic Cannula; Catalog #303380. Terminated |
FMI | K974363 |
| Jun 1, 2005 | Smiths Medical ASD, Inc. Portex Hypodermic Needle-Pro Syringe & Needle 3mL/LL 25G x1''
Catalog Number: 4238 Terminated |
FMI | None listed |
| Dec 9, 2004 | Boston Scientific Corp NAMIC Custom Angiographic Kit, Left Heart Kit. - . Model #: H7496019054110. Catalog #601905411. Firm on kit label: Manufactured by: Boston Scientific Corporation/NAMIC Technology Center, Glens Terminated |
FMI | None listed |
| Dec 9, 2004 | Boston Scientific Corp NAMIC Custom Angiographic Kit, Left Heart Kit - . Model #H749651947220. Catalog # 65194722. Firm on kit label: Manufactured by: Boston Scientific Corporation/NAMIC Technology Center, Glens Falls Terminated |
FMI | None listed |
| Nov 2, 2004 | Kendall Healthcare Products Co Sensi-Touch Infant Lumbar Puncture Tray with Safety Components 22G X1.5 inch
Product Number: 8888715110 Terminated |
FMI | K012736 |
| Nov 2, 2004 | Kendall Healthcare Products Co Sensi-Touch Pediatric Lumbar Puncture Tray with Safety Components 22G X2.5 inch
Product Number: 8888714113 Terminated |
FMI | K012736 |
| Nov 2, 2004 | Kendall Healthcare Products Co Sensi-Touch Adult Lumbar Puncture Tray with Safety Components 22G X3.5 inch
Product Number: 8888713131 Terminated |
FMI | K012736 |
| Nov 2, 2004 | Kendall Healthcare Products Co Sensi-Touch Adult Lumbar Puncture Tray with Safety Components 20G X3.5 inch
Product Number: 8888713123 Terminated |
FMI | K012736 |
| Nov 2, 2004 | Kendall Healthcare Products Co Sensi-Touch Adult Lumbar Puncture Tray with Safety Components 18G X3.5 inch
Product Number: 8888713115 Terminated |
FMI | K012736 |
| Nov 2, 2004 | Kendall Healthcare Products Co Argyle TURKEL Safety Paracentesis Procedure Tray
Product Number: 8888568006 Terminated |
FMI | K012736 |
| Nov 2, 2004 | Kendall Healthcare Products Co Monoject Bone Marrow Biopsy / Aspiration Tray with ''I'' type 16G x 4 inch needle
Product Number: 8881847019 Terminated |
FMI | K012736 |
| Nov 2, 2004 | Kendall Healthcare Products Co Kendall TURKEL Safety Thoracentesis Tray 8F x 5 inch
Product Number: 566075 Terminated |
FMI | K012736 |
| Nov 2, 2004 | Kendall Healthcare Products Co Kendall TURKEL Safety Thoracentesis Tray 8F x 3.5 inch
Product Number: 566059 Terminated |
FMI | K012736 |
| Nov 2, 2004 | Kendall Healthcare Products Co Curity Thoracentesis Tray with Safety Components 14G catheter & 17G needle
Product Number: 5016 Terminated |
FMI | K012736 |
| Nov 2, 2004 | Kendall Healthcare Products Co Curity Thoracentesis Tray with Safety Components 16G needle
Product Number: 5014 Terminated |
FMI | K012736 |
| Nov 2, 2004 | Kendall Healthcare Products Co Goldenberg Snarecoil Bone Marrow Biopsy / Aspiration Basic Tray with Safety Components, 11G x 4 inch Bone Marrow needle only
Product Number: SCE4511 Terminated |
FMI | K012736 |
| Nov 2, 2004 | Kendall Healthcare Products Co Goldenberg Snarecoil Bone Marrow Biopsy / Aspiration Tray with Safety Components, 11G x 4 inch Bone Marrow needle plus ''I'' type Sternal / Iliac needle
Product Number: SCE3411 Terminated |
FMI | K012736 |
| Nov 2, 2004 | Kendall Healthcare Products Co Goldenberg Snarecoil Bone Marrow Biopsy / Aspiration Tray with Safety Components, 16G x 4 inch Bone Marrow needle plus ''I'' type Sternal / Iliac needle
Product Number: SC4511 Terminated |
FMI | K012736 |
| Nov 2, 2004 | Kendall Healthcare Products Co Goldenberg Snarecoil Bone Marrow Biopsy / Aspiration Tray with Safety Components, 16G x 5 inch Bone Marrow needle plus ''I'' type Sternal / Iliac needle
Product Number: SC4508 Terminated |
FMI | K012736 |
| Nov 2, 2004 | Kendall Healthcare Products Co Goldenberg Snarecoil Bone Marrow Biopsy / Aspiration Tray with Safety Components, 11G x 4 inch Bone Marrow needle only
Product Number: SC3411 Terminated |
FMI | K012736 |
| Nov 2, 2004 | Kendall Healthcare Products Co Argyle Pneumothorax Procedure Tray with Safety Components
Product Number: 8888567032 Terminated |
FMI | K012736 |
| Nov 2, 2004 | Kendall Healthcare Products Co Monoject Bone Marrow Biopsy / Aspiration Tray without Bone Marrow needle
Product Number: 8881847993 Terminated |
FMI | K012736 |
| Nov 2, 2004 | Kendall Healthcare Products Co Monoject Bone Marrow Biopsy / Aspiration Tray with ''I'' type 16G x 1 7/8 inch needle
Product Number: 8881847167 Terminated |
FMI | K012736 |
| Nov 2, 2004 | Kendall Healthcare Products Co Monoject Bone Marrow Biopsy / Aspiration Tray with Safety Components 11G x 4 inch
Product Number: 8881847118 Terminated |
FMI | K012736 |
| Nov 2, 2004 | Kendall Healthcare Products Co Monoject Bone Marrow Biopsy / Aspiration Tray with Safety Components 8G x 4 inch
Product Number: 8881847084 Terminated |
FMI | K012736 |
| Nov 2, 2004 | Kendall Healthcare Products Co Monoject Bone Marrow Biopsy / Aspiration Tray with Safety Components 16G x 4 inch
Product Number: 8881847035 Terminated |
FMI | K012736 |
| Nov 2, 2004 | Kendall Healthcare Products Co Monoject Bone Marrow Biopsy / Aspiration Tray with ''I'' type 16G x 3.5 inch needle
Product Number: 8881847027 Terminated |
FMI | K012736 |
| Nov 2, 2004 | Kendall Healthcare Products Co Monoject Bone Marrow Biopsy / Aspiration Tray with Rosenthall needle
Product Number: 8881846169 Terminated |
FMI | K012736 |
| Nov 2, 2004 | Kendall Healthcare Products Co Curity Amniocentesis Tray with Safety Components
Product Number: 97051 Terminated |
FMI | K012736 |
| Nov 2, 2004 | Kendall Healthcare Products Co Curity Infant Lumbar Puncture Tray with Safety Components 22G x 1.5 inch, with manometer
Product Number: 7500 Terminated |
FMI | K012736 |
| Nov 2, 2004 | Kendall Healthcare Products Co Curity Infant Lumbar Puncture Tray with Safety Components 22G x 1.5 inch
Product Number: 7039 Terminated |
FMI | K012736 |
| Nov 2, 2004 | Kendall Healthcare Products Co Curity Pediatric Lumbar Puncture Tray with Safety Components 22G x 3.5 inch
Product Number: 1048 Terminated |
FMI | K012736 |
| Nov 2, 2004 | Kendall Healthcare Products Co Curity Adult Lumbar Puncture Tray with Safety Components 20G x 3.5 inch
Product Code: 1032 Terminated |
FMI | K012736 |
| Nov 2, 2004 | Kendall Healthcare Products Co Curity Adult Lumbar Puncture Tray with Safety Components 18G x 3.5 inch
Product Code: 1017 Terminated |
FMI | K012736 |
| Nov 2, 2004 | Kendall Healthcare Products Co MAGELLAN 25x5/8 TW CLEAR HUB BULK, Non Sterile
Product Number: 7777851558 Terminated |
FMI | K012736 |
| Nov 2, 2004 | Kendall Healthcare Products Co MAGELLAN 23x1'' TW CLEAR HUB BULK, Non Sterile
Product Number: 7777851310 Terminated |
FMI | K012736 |
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