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Disetronic Medical Systems, Inc.

33 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Roche ACCU-CHEK Spirit insulin pump. Part numbers 4540492001, 4759702001 and 4759729001. recall (Z-1646-2009)Disetronic Medical Systems, Inc.2009-05-26
Disetronic D-TRONplus Insulin Pump Battery Pack; Ref/Catalog no. 04697014001. recall (Z-1413-06)Disetronic Medical Systems, Inc.2006-09-12
Accu-Chek Ultraflex 1-infusion set; 8 mm 24'' (60 cm); Catalog Number INF 04540786001. recall (Z-1116-06)Disetronic Medical Systems, Inc.2006-07-08
Accu-Chek Ultraflex-1 infusion set; 8 mm 31'' (80 cm); Catalog number INF 04540808001 (Dis recall (Z-1117-06)Disetronic Medical Systems, Inc.2006-07-08
Accu-Chek Ultraflex-1 infusion set; 8 mm 43'' (110 cm); Catalog number INF 04540824001. recall (Z-1118-06)Disetronic Medical Systems, Inc.2006-07-08
Accu-Chek Ultraflex-1 infusion set; 10 mm 24'' (60 cm); Catalog number INF 04540867001. recall (Z-1119-06)Disetronic Medical Systems, Inc.2006-07-08
Accu-Chek Ultraflex-1 infusion set; 10 mm 31'' (80 cm); Catalog number INF 04540883001 (Di recall (Z-1120-06)Disetronic Medical Systems, Inc.2006-07-08
Accu-Chek Ultraflex-1 infusion set; 10 mm 43'' (110 cm); Catalog number INF 04540905001. recall (Z-1121-06)Disetronic Medical Systems, Inc.2006-07-08
Accu-Chek Ultraflex-2 infusion set; 8 mm 24'' (60 cm); Catalog number INF 04540921001. recall (Z-1122-06)Disetronic Medical Systems, Inc.2006-07-08
Accu-Chek Ultraflex-2 infusion set; 8 mm 31'' (80 cm); Catalog number INF 04540930001. recall (Z-1123-06)Disetronic Medical Systems, Inc.2006-07-08
Accu-Chek Ultraflex-2 infusion set; 8 mm 43'' (110 cm); Catalog number INF 04540948001. recall (Z-1124-06)Disetronic Medical Systems, Inc.2006-07-08
Accu-Chek Ultraflex-2 infusion set; 10 mm 24'' (60 cm); Catalog number INF 04540956001. recall (Z-1125-06)Disetronic Medical Systems, Inc.2006-07-08
Accu-Chek Ultraflex-2 infusion set; 10 mm 31'' (80 cm); Catalog number INF 04540964001. recall (Z-1126-06)Disetronic Medical Systems, Inc.2006-07-08
Accu-Chek Ultraflex-2 infusion set; 10 mm 43'' (110 cm); Catalog number INF 04540972001. recall (Z-1127-06)Disetronic Medical Systems, Inc.2006-07-08
Accu-Chek FlexLink 1 infusion set; 8/30; Ref number 04540778001. (Distributed outside of t recall (Z-1128-06)Disetronic Medical Systems, Inc.2006-07-08
Accu-Chek FlexLink 1 infusion set; 8/60; Ref number 04540794001. (Distributed outside of t recall (Z-1129-06)Disetronic Medical Systems, Inc.2006-07-08
Accu-Chek FlexLink 1 infusion set; 8/80; Ref number 04540816001. (Distributed outside of t recall (Z-1130-06)Disetronic Medical Systems, Inc.2006-07-08
Accu-Chek FlexLink 1 infusion set; 8/110; Ref number 04540832001. (Distributed outside of recall (Z-1131-06)Disetronic Medical Systems, Inc.2006-07-08
Accu-Chek FlexLink 1 infusion set; 10/60; Ref number 04540875001. (Distributed outside of recall (Z-1132-06)Disetronic Medical Systems, Inc.2006-07-08
Accu-Chek FlexLink 1 infusion set; 10/80; Ref number 04540891001. (Distributed outside of recall (Z-1133-06)Disetronic Medical Systems, Inc.2006-07-08
Accu-Chek FlexLink Cannula 8; Ref number 04541219001. (Distributed outside of the U.S. onl recall (Z-1134-06)Disetronic Medical Systems, Inc.2006-07-08
Accu-Chek FlexLink Cannula 10; Ref number 04541227001. (Distributed outside of the U.S. on recall (Z-1135-06)Disetronic Medical Systems, Inc.2006-07-08
Accu-Chek Ultraflex-1 infusion set; 8 mm (30 cm); (Distributed outside the US only). recall (Z-1136-06)Disetronic Medical Systems, Inc.2006-07-08
Accu-Chek Ultraflex-1 infusion set; 10 mm (30 cm); (Distributed outside the US only). recall (Z-1137-06)Disetronic Medical Systems, Inc.2006-07-08
Accu-Chek Flexlink 1 infusion set; 10 mm (30 cm); Catalog number 4626494001. Distributed o recall (Z-1138-06)Disetronic Medical Systems, Inc.2006-07-08
Accu-Chek Flexlink 1 infusion set; 10 mm (110 cm); Catalog number 4540905001. (Distributed recall (Z-1139-06)Disetronic Medical Systems, Inc.2006-07-08
Accu-Chek Ultraflex-8 infusion set; Catalog number 4544773001. recall (Z-1140-06)Disetronic Medical Systems, Inc.2006-07-08
Accu-Chek Ultraflex-10 infusion set; Catalog number 454479001. recall (Z-1141-06)Disetronic Medical Systems, Inc.2006-07-08
Accu-Chek Ultraflex soft DUS 1 infusion set; 8 mm (60 cm); Catalog number 3765512001. (Dis recall (Z-1142-06)Disetronic Medical Systems, Inc.2006-07-08
Disetronic Ultraflex 8/60 infusion set; (Distributed outside of the US only). recall (Z-1143-06)Disetronic Medical Systems, Inc.2006-07-08
Disetronic Ultraflex 8/80 infusion set; Catalog number 4489039001. (Distributed outside of recall (Z-1144-06)Disetronic Medical Systems, Inc.2006-07-08
Disetronic Ultraflex 8/110 infusion set; (Distributed outside of the US only). recall (Z-1145-06)Disetronic Medical Systems, Inc.2006-07-08
Disetronic Ultraflex 10/110 infusion set; (Distributed outside of the US only). recall (Z-1146-06)Disetronic Medical Systems, Inc.2006-07-08

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Every clearance here is in the API, with alerts when new ones post.