Panels › General, Plastic Surgery › Product code FTN · Class 1

Plastic Surgery And Accessories Kit

Regulation 878.3925

0510(k)s in 12 months (0 all time)

15recalls in 12 months (63 all time)

0recalls that name a 510(k)

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Top companies in FTN

Company	510(k)s	Recalls
Argon Medical Devices, Inc	0	19
MEDLINE INDUSTRIES, LP - Northfield	0	16
Medline Industries, LP	0	15
Stradis Medical, LLC dba Stradis Healthcare	0	6
American Contract Systems	0	4
Mentor Texas, Inc	0	1
ROi CPS LLC	0	1
SRI Surgical	0	1

Date	Firm and product	Code	Linked 510(k)
Apr 27, 2011	Argon Medical Devices, Inc Argon Medical Devices Arterial Line Kit, 20ga x 1.75", Part Number 498418, Lot number 99768059 Multi-purpose Kit blister tray coupled with Tyvek lid stock heat-sealed to form a sterile barrier. Terminated	FTN	None listed
Apr 27, 2011	Argon Medical Devices, Inc Argon Medical Devices, Arterial Line Kit, 20ga x 3", Part Number 498411B, Lot number 99767966 Multi-purpose Kit blister tray coupled with Tyvek lid stock heat-sealed to form a sterile barrier. Terminated	FTN	None listed
Apr 27, 2011	Argon Medical Devices, Inc Argon Medical Devices Arterial Line Kit/1, 18ga x 3", Part Number 498110, Lot numbers 99768048 and 99768520 Multi-purpose Kit blister tray coupled with Tyvek lid stock heat-sealed to form a sterile b Terminated	FTN	None listed
Apr 27, 2011	Argon Medical Devices, Inc Argon Medical Devices, Arterial Line Kit/1, 20ga x 3", Part Number 498106, Lot numbers 99767187 and 99767388 Multi-purpose Kit blister tray coupled with Tyvek lid stock heat-sealed to form a sterile Terminated	FTN	None listed
Apr 27, 2011	Argon Medical Devices, Inc Argon Medical Devices, Arterial Line Kit/1 18ga x 6", Part Number 498104, Lot numbers 99767186 and 99768103 Multi-purpose Kit blister tray coupled with Tyvek lid stock heat-sealed to form a sterile b Terminated	FTN	None listed
Apr 27, 2011	Argon Medical Devices, Inc Argon Medical Devices, Arterial Line Kit, Arterial Catheter Mini Kit 20gax6in, Part Number 498101, Lot 99767264 Multi-purpose Kit blister tray coupled with Tyvek lid stock heat-sealed to form a steri Terminated	FTN	None listed
Apr 27, 2011	Argon Medical Devices, Inc Argon Medical Devices Arterial Line Kit/1 20ga x 6", Part Number 498100, Lots 99767185, 99767266, and 99768223 Multi-purpose Kit blister tray coupled with Tyvek lid stock heat-sealed to form a steril Terminated	FTN	None listed
Apr 27, 2011	Argon Medical Devices, Inc Argon Medical Devices Catheter Introducer Kit, One-Piece/Tuohy-Borst Catheter Introducer Tray 8F, Part number 497444, Lot 99766895 Terminated	FTN	None listed
Apr 27, 2011	Argon Medical Devices, Inc Part Number 496311, Lot Number 99768100 Multi-purpose Kit blister tray coupled with Tyvek lid stock heat-sealed to form a sterile barrier. For percutaneous introduction of catheters. Terminated	FTN	None listed
Apr 27, 2011	Argon Medical Devices, Inc Argon Medical Devices Catheter Introducer Kit, PCI Kit with Feather Dilator - Pediatric, 6F, Part Number 496310, Lot Number 99767643 Multi-purpose Kit blister tray coupled with Tyvek lid stock heat-s Terminated	FTN	None listed
Apr 27, 2011	Argon Medical Devices, Inc Argon Medical Devices, Catheter Introducer Kit, Argon PCI Kit with Feather Dilator - Pediatric, 4F, Part Number 496308, Lot Number 99767641 Multi-purpose Kit blister tray coupled with Tyvek lid stock Terminated	FTN	None listed
Apr 27, 2011	Argon Medical Devices, Inc Argon Medical Devices Catheter Introducer Kit, PCI 5 Kit 7F, Part Number 496183, Lot Number 99767488 Multi-purpose Kit blister tray coupled with Tyvek lid stock heat-sealed to form a sterile barrier Terminated	FTN	None listed
Jul 20, 2004	Mentor Texas, Inc Mentor Smooth Round Becker 50 Expander, manufactured by Mentor, Irving, Texas Terminated	FTN	None listed

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