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)
Sep 29, 2010Multi-Med, Inc.
All Med Medical 19ga x .75" Winged Administration Set Model # M1975 Reorder # 50-1921
Terminated
FMIK891919
Sep 29, 2010Multi-Med, Inc.
All Med Medical 19ga x .50" Winged Administration Set w/Y Site Model # M195Y Reorder # 50-1912
Terminated
FMIK891919
Jul 13, 2010Medical 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
FMINone listed
Jul 2, 2010Multi-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
FMIK891919
Jul 2, 2010Multi-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
FMIK891919
Mar 15, 2010Centurion 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
FMINone listed
Jan 22, 2010Exelint 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
FMIK895769
Jul 24, 2009Stat 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
FMINone listed
Nov 5, 2008Covidien LP
ReliOn Insulin syringes - 1cc, 31 G Distributed by: Can-Am Care, Corp., Alpharetta, GA
Terminated
FMIK033373
Sep 30, 2008Greiner 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
FMIK980768
Sep 11, 2008Greiner 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
FMIK980768
Feb 12, 2008Popper & 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
FMINone listed
Sep 20, 2007Becton 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
FMIK024112
May 24, 2007Becton Dickinson & Company
BD AutoShield Pen Needle (Re order Number : 329300)
Terminated
FMIK060007
Sep 9, 2006Becton Dickinson & Company
BD Vacutainer Blood Collection Assembly with BD Blunt Plastic Cannula; Catalog #303380.
Terminated
FMIK974363
Jun 1, 2005Smiths Medical ASD, Inc.
Portex Hypodermic Needle-Pro Syringe & Needle 3mL/LL 25G x1'' Catalog Number: 4238
Terminated
FMINone listed
Dec 9, 2004Boston 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
FMINone listed
Dec 9, 2004Boston 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
FMINone listed
Nov 2, 2004Kendall Healthcare Products Co
Sensi-Touch Infant Lumbar Puncture Tray with Safety Components 22G X1.5 inch Product Number: 8888715110
Terminated
FMIK012736
Nov 2, 2004Kendall Healthcare Products Co
Sensi-Touch Pediatric Lumbar Puncture Tray with Safety Components 22G X2.5 inch Product Number: 8888714113
Terminated
FMIK012736
Nov 2, 2004Kendall Healthcare Products Co
Sensi-Touch Adult Lumbar Puncture Tray with Safety Components 22G X3.5 inch Product Number: 8888713131
Terminated
FMIK012736
Nov 2, 2004Kendall Healthcare Products Co
Sensi-Touch Adult Lumbar Puncture Tray with Safety Components 20G X3.5 inch Product Number: 8888713123
Terminated
FMIK012736
Nov 2, 2004Kendall Healthcare Products Co
Sensi-Touch Adult Lumbar Puncture Tray with Safety Components 18G X3.5 inch Product Number: 8888713115
Terminated
FMIK012736
Nov 2, 2004Kendall Healthcare Products Co
Argyle TURKEL Safety Paracentesis Procedure Tray Product Number: 8888568006
Terminated
FMIK012736
Nov 2, 2004Kendall Healthcare Products Co
Monoject Bone Marrow Biopsy / Aspiration Tray with ''I'' type 16G x 4 inch needle Product Number: 8881847019
Terminated
FMIK012736
Nov 2, 2004Kendall Healthcare Products Co
Kendall TURKEL Safety Thoracentesis Tray 8F x 5 inch Product Number: 566075
Terminated
FMIK012736
Nov 2, 2004Kendall Healthcare Products Co
Kendall TURKEL Safety Thoracentesis Tray 8F x 3.5 inch Product Number: 566059
Terminated
FMIK012736
Nov 2, 2004Kendall Healthcare Products Co
Curity Thoracentesis Tray with Safety Components 14G catheter & 17G needle Product Number: 5016
Terminated
FMIK012736
Nov 2, 2004Kendall Healthcare Products Co
Curity Thoracentesis Tray with Safety Components 16G needle Product Number: 5014
Terminated
FMIK012736
Nov 2, 2004Kendall 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
FMIK012736
Nov 2, 2004Kendall 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
FMIK012736
Nov 2, 2004Kendall 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
FMIK012736
Nov 2, 2004Kendall 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
FMIK012736
Nov 2, 2004Kendall 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
FMIK012736
Nov 2, 2004Kendall Healthcare Products Co
Argyle Pneumothorax Procedure Tray with Safety Components Product Number: 8888567032
Terminated
FMIK012736
Nov 2, 2004Kendall Healthcare Products Co
Monoject Bone Marrow Biopsy / Aspiration Tray without Bone Marrow needle Product Number: 8881847993
Terminated
FMIK012736
Nov 2, 2004Kendall Healthcare Products Co
Monoject Bone Marrow Biopsy / Aspiration Tray with ''I'' type 16G x 1 7/8 inch needle Product Number: 8881847167
Terminated
FMIK012736
Nov 2, 2004Kendall Healthcare Products Co
Monoject Bone Marrow Biopsy / Aspiration Tray with Safety Components 11G x 4 inch Product Number: 8881847118
Terminated
FMIK012736
Nov 2, 2004Kendall Healthcare Products Co
Monoject Bone Marrow Biopsy / Aspiration Tray with Safety Components 8G x 4 inch Product Number: 8881847084
Terminated
FMIK012736
Nov 2, 2004Kendall Healthcare Products Co
Monoject Bone Marrow Biopsy / Aspiration Tray with Safety Components 16G x 4 inch Product Number: 8881847035
Terminated
FMIK012736
Nov 2, 2004Kendall Healthcare Products Co
Monoject Bone Marrow Biopsy / Aspiration Tray with ''I'' type 16G x 3.5 inch needle Product Number: 8881847027
Terminated
FMIK012736
Nov 2, 2004Kendall Healthcare Products Co
Monoject Bone Marrow Biopsy / Aspiration Tray with Rosenthall needle Product Number: 8881846169
Terminated
FMIK012736
Nov 2, 2004Kendall Healthcare Products Co
Curity Amniocentesis Tray with Safety Components Product Number: 97051
Terminated
FMIK012736
Nov 2, 2004Kendall Healthcare Products Co
Curity Infant Lumbar Puncture Tray with Safety Components 22G x 1.5 inch, with manometer Product Number: 7500
Terminated
FMIK012736
Nov 2, 2004Kendall Healthcare Products Co
Curity Infant Lumbar Puncture Tray with Safety Components 22G x 1.5 inch Product Number: 7039
Terminated
FMIK012736
Nov 2, 2004Kendall Healthcare Products Co
Curity Pediatric Lumbar Puncture Tray with Safety Components 22G x 3.5 inch Product Number: 1048
Terminated
FMIK012736
Nov 2, 2004Kendall Healthcare Products Co
Curity Adult Lumbar Puncture Tray with Safety Components 20G x 3.5 inch Product Code: 1032
Terminated
FMIK012736
Nov 2, 2004Kendall Healthcare Products Co
Curity Adult Lumbar Puncture Tray with Safety Components 18G x 3.5 inch Product Code: 1017
Terminated
FMIK012736
Nov 2, 2004Kendall Healthcare Products Co
MAGELLAN 25x5/8 TW CLEAR HUB BULK, Non Sterile Product Number: 7777851558
Terminated
FMIK012736
Nov 2, 2004Kendall Healthcare Products Co
MAGELLAN 23x1'' TW CLEAR HUB BULK, Non Sterile Product Number: 7777851310
Terminated
FMIK012736

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