Panels › General Hospital › Product code MRZ · Class 2
Accessories, Pump, Infusion
Regulation 880.5725
0510(k)s in 12 months (48 all time)
0recalls in 12 months (8 all time)
7recalls that name a 510(k)
Top companies in MRZ
| Company | 510(k)s | Recalls |
|---|---|---|
| Alexander Mfg. Co. | 8 | 0 |
| Welldoc, Inc. | 8 | 0 |
| Icu Medical | 1 | 6 |
| National Custom Ent., Inc. | 3 | 0 |
| Smiths Medical MD, Inc. | 3 | 0 |
| Aidera AB | 2 | 0 |
| Animas Corp. | 1 | 1 |
| American I.V. Products, Inc. | 1 | 0 |
| American I.V. Products, Inc. Dba Aiv, Inc. | 1 | 0 |
| Appro Healthcare, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 15, 2023 | K230718 | UTC 3mL Medication Cartridge Gilero, LLC | MRZ |
| Apr 29, 2022 | K220695 | Elite Biomedical Solutions Dose Request Cord Elite Biomedical Solutions | MRZ |
| Mar 26, 2021 | K201634 | RG 3ml Medication Cartridge Chengdu Shifeng Medical Technology Co., Ltd., CN | MRZ |
| Apr 7, 2020 | K193654 | BlueStar Rx Welldoc, Inc. | MRZ |
| Mar 12, 2020 | K191910 | SpaceStation MRI B. Braun Melsugen AG, DE | MRZ |
| Nov 4, 2019 | K190013 | WellDoc BlueStar Welldoc, Inc. | MRZ |
| Aug 2, 2018 | K173531 | Lockbox for Perfusor Space PCA Infusion Pump B.Braun Medical, Inc. | MRZ |
| Aug 25, 2017 | K171346 | Sapphire Sets Icu Medical | MRZ |
| Jan 12, 2017 | K162532 | WellDoc BlueStar, WellDoc BlueStar Rx Welldoc, Inc. | MRZ |
| Dec 6, 2016 | K160492 | Hospira Sapphire Sets Hospira, Inc. | MRZ |
| Nov 22, 2016 | K162225 | WellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx System Welldoc, Inc. | MRZ |
| Feb 13, 2015 | K142374 | ivWatch Model 400 Ivwatch, LLC | MRZ |
| Dec 18, 2014 | K142333 | SMART LABEL, PROPOFOL American I.V. Products, Inc. Dba Aiv, Inc. | MRZ |
| Jul 8, 2014 | K141273 | WELLDOC DIABETESMANAGER SYSTEM AND DIABETESMANAGER- RX SYSTE Welldoc, Inc. | MRZ |
| Dec 16, 2013 | K132618 | ONETOUCH REVEAL Lifescan, Inc. | MRZ |
| Apr 12, 2012 | K120209 | PATIENT CONTROLLED ANALGESIA (PCA) BUTTON CABLE American I.V. Products, Inc. | MRZ |
| Feb 24, 2012 | K120314 | WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM Welldoc, Inc. | MRZ |
| Oct 14, 2011 | K112370 | WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM Welldoc, Inc. | MRZ |
| Dec 7, 2010 | K101806 | AIDERA DIASEND SYSTEM Aidera AB, SE | MRZ |
| Jul 15, 2010 | K100066 | DIABETESMANAGER SYSTEM, DIABETESMANAGER-RX SYSTEM MODEL VERSION 1.1 Welldoc, Inc. | MRZ |
| Jun 12, 2009 | K091181 | LOCKBOX FOR USE WITH MEDFUSION 3000 SERIES PUMPS Smiths Medical MD, Inc. | MRZ |
| Feb 3, 2009 | K083221 | AIDERA DIASEND Aidera AB, SE | MRZ |
| Dec 17, 2008 | K082783 | CADD -SOLIS MEDICATION SAFETY SOFTWARE: ADMINISTRATOR AND POINT-OF-CARE Smiths Medical MD, Inc. | MRZ |
| May 15, 2008 | K080587 | EZ MANAGER MAX DIABETES MANAGEMENT SOFTWARE Animas Corp. | MRZ |
| May 15, 2008 | K080227 | ACCU-CHEK 360 DIABETES MANAGEMENT SYSTEM Roche Diagnostics Corp. | MRZ |
| Feb 13, 2008 | K072955 | CADD-SENTRY PRO MEDICATION SAFETY SOFTWARE-ADMINISTRATOR (21-6275), POINT OF CARE (21-6276) Smiths Medical MD, Inc. | MRZ |
| Oct 17, 2007 | K070438 | MEDTRONIC MINIMED CARELINK USB CONNECTOR, MODEL NMT 7305 Medtronic Minimed, Inc. | MRZ |
| Sep 4, 2007 | K071418 | DANA 3CC SYRINGE INSULIN RESERVOIR Sooil Development Co., Ltd. | MRZ |
| May 19, 2005 | K051079 | HOSPIRA GEMSTAR INFUSION PUMP SYSTEM WITH HOSPIRA GEMSTAR SPRING ASSIST MECHANISM LOCKBOX-7 THERAPY Hospicare, Inc. | MRZ |
| Apr 1, 2003 | K030936 | RITA CLIPS FOR INFUSION PUMPS Rita Medical Systems, Inc. | MRZ |
| Feb 7, 2003 | K023890 | PREPARE CARTRIDGE Appro Healthcare, Inc. | MRZ |
| Aug 6, 2002 | K021974 | MEDTRONIC MINIMED COMLINK, HARDWARE MODEL 7304 & SOFTWARE MODEL 7311 Minimed, Inc. | MRZ |
| Sep 12, 2001 | K012266 | SHERWOOD 224, 324 FEEDING PUMP & K524 INTRI-FLUSH, MODEL N7213IWC2 National Custom Ent., Inc. | MRZ |
| Sep 12, 2001 | K012262 | BAXTER AS40A, AS41 SYRINGE PUMP, MODEL N61WC National Custom Ent., Inc. | MRZ |
| Sep 12, 2001 | K012259 | MEDFUSION 2001 & 2010, MODEL N7215IWC National Custom Ent., Inc. | MRZ |
| Apr 4, 1999 | K990091 | S.P.A.R STERILE AMBULATORY RESERVOIR Faulding Pharmaceutical Co. | MRZ |
| Apr 20, 1998 | K980165 | INFUTEST 2000 INFUSION DEVICE ANALYZER Datrend Systems, Inc., CA | MRZ |
| Apr 17, 1998 | K961486 | IVAC MEDSYSTEM III, INFUSION PUMP W/DRUG EDITING SOFTWARE KIT Ivac Medical Systems | MRZ |
| Jan 9, 1998 | K970678 | THE HARVARD LIBRARY Harvard Apparatus, Inc. | MRZ |
| Oct 20, 1997 | K972780 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL625 Alexander Mfg. Co. | MRZ |
| Oct 20, 1997 | K972779 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS3030-P Alexander Mfg. Co. | MRZ |
| Jul 18, 1997 | K962159 | STERILE AMBULATORY RESERVOIR 60ML/100ML Faulding Medical Device Co. | MRZ |
| Jul 3, 1997 | K972089 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS06224 Alexander Mfg. Co. | MRZ |
| May 27, 1997 | K971237 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL8108 Alexander Mfg. Co. | MRZ |
| May 27, 1997 | K971234 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL825 Alexander Mfg. Co. | MRZ |
| May 27, 1997 | K971213 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY # GL825-P Alexander Mfg. Co. | MRZ |
| May 27, 1997 | K971212 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL4018 Alexander Mfg. Co. | MRZ |
| May 27, 1997 | K970786 | ALEXANDER MFG. RECHARGEABLE BATTERY (MODEL M7) Alexander Mfg. Co. | MRZ |
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