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Calculator, Drug Dose

Regulation 868.1890

5510(k)s in 12 months (56 all time)
3recalls in 12 months (14 all time)
13recalls that name a 510(k)
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Top companies in NDC

Company510(k)sRecalls
Monarch Medical Technologies62
Roche Diabetes Care, Inc.16
Medtronic Minimed24
Voluntis Sa.51
Companion Medical, Inc.41
Glytec, LLC40
Glooko, Inc.20
Roche Diagnostics Corp.20
Sanofi20
Welldoc, Inc.20
Decided510(k)Device and applicantCode
Oct 5, 2026K261939Glucommander
Glytec, LLC
NDC
May 27, 2026K254102Glucommander
Glytec, LLC
NDC
May 1, 2026K260910EndoTool IV Cloud 1.0
Glooko, Inc.
NDC
Jan 8, 2026K253512MiniMed Go App
Medtronic Minimed
NDC
Dec 23, 2025K253281UpDoc
Updoc, Inc.
NDC
Aug 20, 2025K252104T1D1
Comerge AG, CH
NDC
Dec 11, 2024K241088EndoTool IV (3.1)
Monarch Medical Technologies
NDC
Nov 12, 2024K242775InPen System App (MMT-8060 (iOS), MMT-8061 (Android))
Medtronic Minimed
NDC
Aug 21, 2024K242066iSage Rx
Amalgam Rx, Inc.
NDC
Dec 12, 2023K232451Insulia Bolus Companion
Voluntis Sa., FR
NDC
Jul 28, 2023K230813BlueStar and BlueStar Rx
Welldoc, Inc.
NDC
Mar 15, 2023K221924Digital Routines
Gnc Holdings, LLC
NDC
Oct 28, 2021K211160EndoTool SubQ 2.1
Monarch Medical Technologies, LLC
NDC
Sep 8, 2021K203434BlueStar Rx
Welldoc, Inc.
NDC
Jun 4, 2021K202596Insulia Diabetes Management Companion
Voluntis Sa., FR
NDC
Aug 7, 2020K201619EndoTool IV System
Monarch Medical Technologies, LLC
NDC
Jun 18, 2020K201337InPen System
Companion Medical, Inc.
NDC
Mar 17, 2020K200443EndoTool IV 1.10
Monarch Medical Technologies, LLC
NDC
Feb 18, 2020K190487InPen Dose Calculator
Companion Medical, Inc.
NDC
Feb 10, 2020K192841InPen System
Companion Medical, Inc.
NDC
Feb 4, 2019K181916d-Nav System
Hygieia, Inc.
NDC
Sep 20, 2018K180366EndoTool SubQ
Al Pacheco and Associates
NDC
Jul 6, 2018K181327InPen Dose Calculator
Companion Medical, Inc.
NDC
Feb 2, 2018K171450Glooko Mobile Insulin Dosing System
Glooko, Inc.
NDC
Nov 7, 2017K172177Insulia Diabetes Management Companion
Voluntis Sa., FR
NDC
Sep 18, 2017K163664Health-e-Connect System with IDA
Alr Technologies
NDC
Aug 4, 2017K152300Glucommander
Glytec, LLC
NDC
Jun 19, 2017K170669Insulia Diabetes Management Companion
Voluntis Sa., FR
NDC
Jun 7, 2017K160673Insulin Algorithms System
Insulin Algorithms
NDC
May 26, 2017K171230My Dose Coach
Sanofi
NDC
Mar 22, 2017K163099My Dose Coach
Sanofi, Inc.
NDC
Mar 7, 2017K161865iSage Rx (iSage Rx Basal Insulin Titration)
Isag Rx, Inc.
NDC
Dec 22, 2016K160949Go Dose System
Eli Lilly and Company
NDC
Nov 9, 2016K161433Insulia Diabetes Management Companion
Voluntis Sa., FR
NDC
Jun 3, 2015K150910ACCU-CHEK Connect Diabetes Management App
Roche Diabetes Care, Inc.
NDC
Apr 24, 2015K142918EndoTool SubQ
Monarch Medical Technologies
NDC
Mar 16, 2015K141929ACCU-CHEK CONNECT DIABETES MANAGEMENT APP
Roche Diagnostics Corporation
NDC
Sep 24, 2014K142123REACH ACCESS TELEMEDICINE DOSE CALCULATOR
Reach Health, Inc.
NDC
Sep 15, 2014K141321GLUCOSTABILIZER INSULIN DOSING CALCULATOR
Medical Decision Network
NDC
Apr 17, 2014K132547ENDO TOOL GLUCOSE MANAGEMENT SYSTEM (EGMS)
Monarch Medical Technologies
NDC
Aug 27, 2012K121542PICIS WEIGHT BASED DOSE CONVERTER
Picis, Inc.
NDC
May 8, 2012K113853G+ SYSTEM
Glytec, LLC
NDC
Jun 28, 2010K101344G+ SYSTEM
Glytec, LLC (Formally Known AS Glucotec, Inc.)
NDC
Nov 7, 2008K082512INTELLIGENT DOSING SYSTEM FOR INSULIN-MY INSULIN DOSER
Dimensional Dosing Systems, Inc.
NDC
Aug 21, 2008K081388GLUCOCARE INTENSIVE GLYCEMIC CONTROL SYSTEM
Pronia Medical System, LLC
NDC
Oct 12, 2007K071713CLARIAN GLUCOSE STABILIZER INSULIN DOSING CALCULATOR
Medical Decisions Network
NDC
Jun 14, 2006K053137ENDOTOOL DRUG DOSE CALCULATOR
MD Scientific, LLC
NDC
Jun 7, 2006K061110GLUCOMMANDER PLUS
Collaborativemed, LLC
NDC
Apr 8, 2005K043529ACCU-CHEK ADVISOR INSULIN GUIDANCE SOFTWARE
Roche Diagnostics Corp.
NDC
Aug 9, 2001K011571TRXF INTELLIGENT DOSING SYSTEM (IDS) -DOSING CALCULATOR SUITE
The RX Files Corp.
NDC

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