Panels › General Hospital › Product code LZG · Class 2

Pump, Infusion, Insulin

Regulation 880.5725

2510(k)s in 12 months (85 all time)

3recalls in 12 months (126 all time)

96recalls that name a 510(k)

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Top companies in LZG

Company	510(k)s	Recalls
Disetronic Medical Systems	10	33
Animas Corp.	7	25
Medtronic Minimed	15	17
Insulet Corp.	13	14
Roche Diagnostics	3	12
Smiths Medical MD, Inc.	2	8
Tandem Diabetes Care, Inc.	7	1
Valeritas, Inc.	2	5
Nipro Diabetes Systems, Inc.	3	1
Abbott Diabetes Care, Inc.	3	0

Date	Firm and product	Code	Linked 510(k)
Apr 16, 2009	Smiths Medical MD, Inc. Deltec Cozmo Insulin Pump, Model 1700 containing 1800 software. Deltec Cozmo Insulin Pumps are ambulatory electromechanical pumps used for delivering insulin to patients with diabetes. The pump is u Terminated	LZG	K062323
Apr 16, 2009	Smiths Medical MD, Inc. Deltec Cozmo Insulin Pump, Model 1800. Deltec Cozmo Insulin Pumps are ambulatory electromechanical pumps used for delivering insulin to patients with diabetes. The pump is used mainly by homecare pa Terminated	LZG	K062323
Mar 3, 2009	Animas Corporation Meter Remote for OneTouch Ping Glucose Management System Terminated	LZG	K080639
Nov 25, 2008	Animas Corporation Battery Caps used with Animas IR1250 Insulin Pump. The pump is used to help maintain blood glucose targets. Terminated	LZG	K042873
Nov 25, 2008	Animas Corporation Battery Caps used with Animas IR1200 Insulin Pump. The pump is used to help maintain blood glucose targets. Terminated	LZG	K032257
Nov 25, 2008	Animas Corporation Battery Caps used with Animas 2020 Insulin Pump. The pump is used to help maintain blood glucose targets. Terminated	LZG	K042873
Nov 25, 2008	Animas Corporation Battery Caps used with OneTouch Ping Glucose Monitoring System. The pump is used to help maintain blood glucose targets. Terminated	LZG	K080639
Nov 25, 2008	Animas Corporation Battery Caps used with insulin pumps and glucose monitoring systems. The pump is used to help maintain blood glucose targets. Terminated	LZG	K080639
Nov 7, 2008	Animas Corporation One Touch Ping Glucose Monitoring System Combines the functionality of OneTouch(R) Ping (TM) Insulin Pump and a OneTouch(R) Ping (TM) Meter Remote through radio frequency (RF) communication. Togethe Terminated	LZG	K080639
Sep 1, 2008	Smiths Medical MD, Inc. Deltec Cozmo Insulin Pump, model 21-1800. This is similar to the currently distributed Deltec Cozmo Insulin Pump Model 1700, with the exception of updated software that enhanced certain features and Terminated	LZG	K020655 K031738 +1
Sep 1, 2008	Smiths Medical MD, Inc. Deltec Cozmo Insulin Pump, model 21-1700. A syringe infusion pump designed for Continuous Subcutaneous Insulin Infusion for the control of diabetes. Reorder Numbers: 21-1701-02/32/33/36/44/49/51/54/6 Terminated	LZG	K020655 K031738
Aug 15, 2008	Smiths Medical MD, Inc. Deltec Cozmo Insulin Pump, Model 1800 Smiths Medical International Ltd WD24 4LG UK, Smiths Medical MD, Inc., St Paul, MN 55112. This Pump is similar to the currently distributed Deltec Cosmo Insulin Terminated	LZG	K062323
Aug 15, 2008	Smiths Medical MD, Inc. Deltec Cozmo Insulin Pump, Model 1700, Smiths Medical International Ltd WD24 4LG UK, Smiths Medical MD, Inc., St Paul, MN 55112. This is a syringe infusion pump intended for Continuous Subcutaneous I Terminated	LZG	K020655 K031738 +1
Jul 7, 2007	Medtronic MiniMed Medtronic MiniMed Paradigm Insulin Infusion Pumps for the following Paradigm models: MMT-511, MMT-512, MMT-712, MMT-515, MMT-715, MMT-522 and MMT-722 Terminated	LZG	K001829 K030531 +3
Sep 12, 2006	Disetronic Medical Systems, Inc. Disetronic D-TRONplus Insulin Pump Battery Pack; Ref/Catalog no. 04697014001. Terminated	LZG	K043000
Jul 8, 2006	Disetronic Medical Systems, Inc. Disetronic Ultraflex 10/110 infusion set; (Distributed outside of the US only). Terminated	LZG	None listed
Jul 8, 2006	Disetronic Medical Systems, Inc. Disetronic Ultraflex 8/110 infusion set; (Distributed outside of the US only). Terminated	LZG	None listed
Jul 8, 2006	Disetronic Medical Systems, Inc. Disetronic Ultraflex 8/80 infusion set; Catalog number 4489039001. (Distributed outside of the US only). Terminated	LZG	None listed
Jul 8, 2006	Disetronic Medical Systems, Inc. Disetronic Ultraflex 8/60 infusion set; (Distributed outside of the US only). Terminated	LZG	None listed
Jul 8, 2006	Disetronic Medical Systems, Inc. Accu-Chek Ultraflex soft DUS 1 infusion set; 8 mm (60 cm); Catalog number 3765512001. (Distributed outside of the US only). Terminated	LZG	None listed
Jul 8, 2006	Disetronic Medical Systems, Inc. Accu-Chek Ultraflex-10 infusion set; Catalog number 454479001. Terminated	LZG	None listed
Jul 8, 2006	Disetronic Medical Systems, Inc. Accu-Chek Ultraflex-8 infusion set; Catalog number 4544773001. Terminated	LZG	None listed
Jul 8, 2006	Disetronic Medical Systems, Inc. Accu-Chek Flexlink 1 infusion set; 10 mm (110 cm); Catalog number 4540905001. (Distributed outside of the US only). Terminated	LZG	None listed
Jul 8, 2006	Disetronic Medical Systems, Inc. Accu-Chek Flexlink 1 infusion set; 10 mm (30 cm); Catalog number 4626494001. Distributed outside of the US only). Terminated	LZG	None listed
Jul 8, 2006	Disetronic Medical Systems, Inc. Accu-Chek Ultraflex-1 infusion set; 10 mm (30 cm); (Distributed outside the US only). Terminated	LZG	None listed
Jul 8, 2006	Disetronic Medical Systems, Inc. Accu-Chek Ultraflex-1 infusion set; 8 mm (30 cm); (Distributed outside the US only). Terminated	LZG	None listed
Jul 8, 2006	Disetronic Medical Systems, Inc. Accu-Chek FlexLink Cannula 10; Ref number 04541227001. (Distributed outside of the U.S. only). Terminated	LZG	None listed
Jul 8, 2006	Disetronic Medical Systems, Inc. Accu-Chek FlexLink Cannula 8; Ref number 04541219001. (Distributed outside of the U.S. only). Terminated	LZG	None listed
Jul 8, 2006	Disetronic Medical Systems, Inc. Accu-Chek FlexLink 1 infusion set; 10/80; Ref number 04540891001. (Distributed outside of the U.S. only). Terminated	LZG	None listed
Jul 8, 2006	Disetronic Medical Systems, Inc. Accu-Chek FlexLink 1 infusion set; 10/60; Ref number 04540875001. (Distributed outside of the U.S. only). Terminated	LZG	None listed
Jul 8, 2006	Disetronic Medical Systems, Inc. Accu-Chek FlexLink 1 infusion set; 8/110; Ref number 04540832001. (Distributed outside of the U.S. only). Terminated	LZG	None listed
Jul 8, 2006	Disetronic Medical Systems, Inc. Accu-Chek FlexLink 1 infusion set; 8/80; Ref number 04540816001. (Distributed outside of the U.S. only). Terminated	LZG	None listed
Jul 8, 2006	Disetronic Medical Systems, Inc. Accu-Chek FlexLink 1 infusion set; 8/60; Ref number 04540794001. (Distributed outside of the U.S. only). Terminated	LZG	None listed
Jul 8, 2006	Disetronic Medical Systems, Inc. Accu-Chek FlexLink 1 infusion set; 8/30; Ref number 04540778001. (Distributed outside of the U.S. only). Terminated	LZG	None listed
Jul 8, 2006	Disetronic Medical Systems, Inc. Accu-Chek Ultraflex-2 infusion set; 10 mm 43'' (110 cm); Catalog number INF 04540972001. Terminated	LZG	K033892
Jul 8, 2006	Disetronic Medical Systems, Inc. Accu-Chek Ultraflex-2 infusion set; 10 mm 31'' (80 cm); Catalog number INF 04540964001. Terminated	LZG	K033892
Jul 8, 2006	Disetronic Medical Systems, Inc. Accu-Chek Ultraflex-2 infusion set; 10 mm 24'' (60 cm); Catalog number INF 04540956001. Terminated	LZG	K033892
Jul 8, 2006	Disetronic Medical Systems, Inc. Accu-Chek Ultraflex-2 infusion set; 8 mm 43'' (110 cm); Catalog number INF 04540948001. Terminated	LZG	K033892
Jul 8, 2006	Disetronic Medical Systems, Inc. Accu-Chek Ultraflex-2 infusion set; 8 mm 31'' (80 cm); Catalog number INF 04540930001. Terminated	LZG	K033892
Jul 8, 2006	Disetronic Medical Systems, Inc. Accu-Chek Ultraflex-2 infusion set; 8 mm 24'' (60 cm); Catalog number INF 04540921001. Terminated	LZG	K033892
Jul 8, 2006	Disetronic Medical Systems, Inc. Accu-Chek Ultraflex-1 infusion set; 10 mm 43'' (110 cm); Catalog number INF 04540905001. Terminated	LZG	K033892
Jul 8, 2006	Disetronic Medical Systems, Inc. Accu-Chek Ultraflex-1 infusion set; 10 mm 31'' (80 cm); Catalog number INF 04540883001 (Distributed U.S. and Canada) and Ref. No 04626524001 (Distributed outside of the the U.S. only). Terminated	LZG	K033892
Jul 8, 2006	Disetronic Medical Systems, Inc. Accu-Chek Ultraflex-1 infusion set; 10 mm 24'' (60 cm); Catalog number INF 04540867001. Terminated	LZG	K033892
Jul 8, 2006	Disetronic Medical Systems, Inc. Accu-Chek Ultraflex-1 infusion set; 8 mm 43'' (110 cm); Catalog number INF 04540824001. Terminated	LZG	K033892
Jul 8, 2006	Disetronic Medical Systems, Inc. Accu-Chek Ultraflex-1 infusion set; 8 mm 31'' (80 cm); Catalog number INF 04540808001 (Distributed U.S. and Canada) and Ref No. 04626478001 (Distributed outside the U.S. only). Terminated	LZG	K033892
Jul 8, 2006	Disetronic Medical Systems, Inc. Accu-Chek Ultraflex 1-infusion set; 8 mm 24'' (60 cm); Catalog Number INF 04540786001. Terminated	LZG	K033892
Dec 23, 2005	Animas Corporation Isulin Pump. Model IR1250 Terminated	LZG	K042873
Dec 23, 2005	Animas Corporation Isulin Pump. Model IR1200 Terminated	LZG	K032257
Dec 23, 2005	Animas Corporation Isulin Pump. Model IR1000 Terminated	LZG	K021439
Dec 23, 2005	Animas Corporation Isulin Pump. Models R1000 Terminated	LZG	K993184

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