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

Company	510(k)s	Recalls
Kendall Healthcare Products Co	0	91
Multi-Med, Inc.	2	75
Becton, Dickinson & CO	10	16
Cardinal Health 200, LLC	0	23
International Medsurg Connection	2	20
Bd Becton Dickinson Vacutainer Systems Preanalytic	20	0
Vidacare Corporation	14	2
B.Braun Medical, Inc.	5	10
Terumo Europe N.V.	15	0
Terumo Medical Corp.	4	10

Date	Firm and product	Code	Linked 510(k)
Nov 2, 2004	Kendall Healthcare Products Co Kendall MONOJECT MAGELLAN SAFETY NEEDLE 20G X 1 inch Product Number: 8881850010 Terminated	FMI	K012736
Nov 2, 2004	Kendall Healthcare Products Co Kendall MONOJECT MAGELLAN 3cc Syringe with Safety Needle 18G X 1 inch Product Number: 8881833810 Terminated	FMI	K012736
Nov 2, 2004	Kendall Healthcare Products Co Kendall MONOJECT MAGELLAN 3cc Syringe with Safety Needle 25G X 5/8 inch Product Number: 8881833558 Terminated	FMI	K012736
Nov 2, 2004	Kendall Healthcare Products Co Kendall MONOJECT MAGELLAN 3cc Syringe with Safety Needle 23G X 1 inch Product Number: 8881833310 Terminated	FMI	K012736
Nov 2, 2004	Kendall Healthcare Products Co Kendall MONOJECT MAGELLAN 3cc Syringe with Safety Needle 22G X 1.5 inch Product Number: 8881833215 Terminated	FMI	K012736
Nov 2, 2004	Kendall Healthcare Products Co Kendall MONOJECT MAGELLAN 3cc Syringe with Safety Needle 22G X 1 inch Product Number: 8881833210 Terminated	FMI	K012736
Nov 2, 2004	Kendall Healthcare Products Co Kendall MONOJECT MAGELLAN 3cc Syringe with Safety Needle 21G X 1 inch Product Number: 8881833110 Terminated	FMI	K012736
Nov 2, 2004	Kendall Healthcare Products Co Kendall MONOJECT MAGELLAN 3cc Syringe with Safety Needle 20G X 1.5 inch Product Number: 8881833015 Terminated	FMI	K012736
Nov 2, 2004	Kendall Healthcare Products Co Kendall MONOJECT MAGELLAN 3cc Syringe with Safety Needle 20G X 1 inch Product Code: 8881833010 Terminated	FMI	K012736
Jul 20, 2004	Smiths Medical ASD, Inc. Portex Hypodermic Needle-Pro Syringe and Needle 1ml/LS Small Gauge Safety 27 g x 1/2'' Reference Number: 4313 Terminated	FMI	K011925
Nov 6, 2003	Bard Access Systems, Inc Bard -Winged Infusion Set with Injection Site. Sterile, Non-Pyrogenic. Terminated	FMI	K863606

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