Panels › Gastroenterology, Urology › Product code PIF · Class 2

Gastrointestinal Tubes With Enteral Specific Connectors

Regulation 876.5980

3510(k)s in 12 months (52 all time)

1recalls in 12 months (112 all time)

111recalls that name a 510(k)

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Top companies in PIF

Company	510(k)s	Recalls
Xeridiem Mediem Medical Devices Inc	0	105
Boston Scientific Corp	2	4
Covidien	3	0
Medline Industries, Inc.	3	0
Vesco Medical	3	0
Applied Medical Technology, Inc.	1	1
Cair Lgl	2	0
Cardinalhealth	2	0
Cedic S.R.L.	2	0
Degania Silicone , Ltd.	2	0

Date	Firm and product	Code	Linked 510(k)
Dec 23, 2015	Xeridiem Mediem Medical Devices Inc EndoVive 3s Low Profile Balloon Kits Part Number: M00548510 (XMD P/N 70-0050-216) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for e Terminated	PIF	K142297
Dec 23, 2015	Xeridiem Mediem Medical Devices Inc EndoVive 3s Low Profile Balloon Kits Part Number: M00548350 (XMD P/N 70-0050-214) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for e Terminated	PIF	K142297
Dec 23, 2015	Xeridiem Mediem Medical Devices Inc EndoVive 3s Low Profile Balloon Kits Part Number: M00548230 (XMD P/N 70-0050-212) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for e Terminated	PIF	K142297
Dec 23, 2015	Xeridiem Mediem Medical Devices Inc EndoVive 3s Low Profile Balloon Kits Part Number: M00549310 (XMD P/N 70-0050-122) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for e Terminated	PIF	K142297
Dec 23, 2015	Xeridiem Mediem Medical Devices Inc EndoVive 3s Low Profile Balloon Kits Part Number: M00548820 (XMD P/N 70-0050-120) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for e Terminated	PIF	K142297
Dec 23, 2015	Xeridiem Mediem Medical Devices Inc EndoVive 3s Low Profile Balloon Kits Part Number: M00548660 (XMD P/N 70-0050-118) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for e Terminated	PIF	K142297
Dec 23, 2015	Xeridiem Mediem Medical Devices Inc EndoVive 3s Low Profile Balloon Kits Part Number: M00548500 (XMD P/N 70-0050-116) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for e Terminated	PIF	K142297
Dec 23, 2015	Xeridiem Mediem Medical Devices Inc EndoVive 3s Low Profile Balloon Kits Part Number: M00548340 (XMD P/N 70-0050-114) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for e Terminated	PIF	K142297
Dec 23, 2015	Xeridiem Mediem Medical Devices Inc EndoVive 3s Low Profile Balloon Kits Part Number: M00548220 (XMD P/N 70-0050-112) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for e Terminated	PIF	K142297
Dec 23, 2015	Xeridiem Mediem Medical Devices Inc EndoVive 3s Low Profile Balloon Kits Part Number: M00548330 (XMD P/N 70-0050-014) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for e Terminated	PIF	None listed
Dec 23, 2015	Xeridiem Mediem Medical Devices Inc EndoVive 3s Low Profile Balloon Kits Part Number: M00548460 (XMD P/N 70-0050-D14) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for e Terminated	PIF	K142297
Nov 20, 2015	MOOG Medical Devices Group Catalog No. INF0020-A EnteraLite Infinity Enteral Pump Delivery Set with ENFit Connector System and Transitional Stepped Connector (spiked set); Catalog No. INF0500-A - 500ml EnteraLite Infinity Ente Terminated	PIF	K142539

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