510(k) clearances for Accessories, Pump, Infusion
48 on file
- Gilero, LLCJun 15, 2023
K230718 · UTC 3mL Medication Cartridge
- Elite Biomedical SolutionsApr 29, 2022
K220695 · Elite Biomedical Solutions Dose Request Cord
- Chengdu Shifeng Medical Technology Co., Ltd.Mar 26, 2021
K201634 · RG 3ml Medication Cartridge
- Welldoc, Inc.Apr 7, 2020
K193654 · BlueStar Rx
- B. Braun Melsugen AGMar 12, 2020
K191910 · SpaceStation MRI
- Welldoc, Inc.Nov 4, 2019
K190013 · WellDoc BlueStar
- B.Braun Medical, Inc.Aug 2, 2018
K173531 · Lockbox for Perfusor Space PCA Infusion Pump
- Icu MedicalAug 25, 2017
K171346 · Sapphire Sets
- Welldoc, Inc.Jan 12, 2017
K162532 · WellDoc BlueStar, WellDoc BlueStar Rx
- Hospira, Inc.Dec 6, 2016
K160492 · Hospira Sapphire Sets
- Welldoc, Inc.Nov 22, 2016
K162225 · WellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx System
- Ivwatch, LLCFeb 13, 2015
K142374 · ivWatch Model 400
- American I.V. Products, Inc. Dba Aiv, Inc.Dec 18, 2014
K142333 · SMART LABEL, PROPOFOL
- Welldoc, Inc.Jul 8, 2014
K141273 · WELLDOC DIABETESMANAGER SYSTEM AND DIABETESMANAGER- RX SYSTE
- Lifescan, Inc.Dec 16, 2013
K132618 · ONETOUCH REVEAL
- American I.V. Products, Inc.Apr 12, 2012
K120209 · PATIENT CONTROLLED ANALGESIA (PCA) BUTTON CABLE
- Welldoc, Inc.Feb 24, 2012
K120314 · WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM
- Welldoc, Inc.Oct 14, 2011
K112370 · WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM
- Aidera ABDec 7, 2010
K101806 · AIDERA DIASEND SYSTEM
- Welldoc, Inc.Jul 15, 2010
K100066 · DIABETESMANAGER SYSTEM, DIABETESMANAGER-RX SYSTEM MODEL VERSION 1.1
- Smiths Medical MD, Inc.Jun 12, 2009
K091181 · LOCKBOX FOR USE WITH MEDFUSION 3000 SERIES PUMPS
- Aidera ABFeb 3, 2009
K083221 · AIDERA DIASEND
- Smiths Medical MD, Inc.Dec 17, 2008
K082783 · CADD -SOLIS MEDICATION SAFETY SOFTWARE: ADMINISTRATOR AND POINT-OF-CARE
- Roche Diagnostics Corp.May 15, 2008
K080227 · ACCU-CHEK 360 DIABETES MANAGEMENT SYSTEM
- Animas Corp.May 15, 2008
K080587 · EZ MANAGER MAX DIABETES MANAGEMENT SOFTWARE
- Smiths Medical MD, Inc.Feb 13, 2008
K072955 · CADD-SENTRY PRO MEDICATION SAFETY SOFTWARE-ADMINISTRATOR (21-6275), POINT OF CARE (21-6276)
- Medtronic Minimed, Inc.Oct 17, 2007
K070438 · MEDTRONIC MINIMED CARELINK USB CONNECTOR, MODEL NMT 7305
- Sooil Development Co., Ltd.Sep 4, 2007
K071418 · DANA 3CC SYRINGE INSULIN RESERVOIR
- Hospicare, Inc.May 19, 2005
K051079 · HOSPIRA GEMSTAR INFUSION PUMP SYSTEM WITH HOSPIRA GEMSTAR SPRING ASSIST MECHANISM LOCKBOX-7 THERAPY
- Rita Medical Systems, Inc.Apr 1, 2003
K030936 · RITA CLIPS FOR INFUSION PUMPS
- Appro Healthcare, Inc.Feb 7, 2003
K023890 · PREPARE CARTRIDGE
- Minimed, Inc.Aug 6, 2002
K021974 · MEDTRONIC MINIMED COMLINK, HARDWARE MODEL 7304 & SOFTWARE MODEL 7311
- National Custom Ent., Inc.Sep 12, 2001
K012266 · SHERWOOD 224, 324 FEEDING PUMP & K524 INTRI-FLUSH, MODEL N7213IWC2
- National Custom Ent., Inc.Sep 12, 2001
K012262 · BAXTER AS40A, AS41 SYRINGE PUMP, MODEL N61WC
- National Custom Ent., Inc.Sep 12, 2001
K012259 · MEDFUSION 2001 & 2010, MODEL N7215IWC
- Faulding Pharmaceutical Co.Apr 4, 1999
K990091 · S.P.A.R STERILE AMBULATORY RESERVOIR
- Datrend Systems, Inc.Apr 20, 1998
K980165 · INFUTEST 2000 INFUSION DEVICE ANALYZER
- Ivac Medical SystemsApr 17, 1998
K961486 · IVAC MEDSYSTEM III, INFUSION PUMP W/DRUG EDITING SOFTWARE KIT
- Harvard Apparatus, Inc.Jan 9, 1998
K970678 · THE HARVARD LIBRARY
- Alexander Mfg. Co.Oct 20, 1997
K972779 · ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS3030-P
- Alexander Mfg. Co.Oct 20, 1997
K972780 · ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL625
- Faulding Medical Device Co.Jul 18, 1997
K962159 · STERILE AMBULATORY RESERVOIR 60ML/100ML
- Alexander Mfg. Co.Jul 3, 1997
K972089 · ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS06224
- Alexander Mfg. Co.May 27, 1997
K971213 · ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY # GL825-P
- Alexander Mfg. Co.May 27, 1997
K971237 · ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL8108
- Alexander Mfg. Co.May 27, 1997
K971212 · ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL4018
- Alexander Mfg. Co.May 27, 1997
K970786 · ALEXANDER MFG. RECHARGEABLE BATTERY (MODEL M7)
- Alexander Mfg. Co.May 27, 1997
K971234 · ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL825