MRZ · Class II · 21 CFR 880.5725

FDA Product Code MRZ: Accessories, Pump, Infusion

Leading manufacturers include Alexander Mfg. Co., Welldoc, Inc. and National Custom Ent., Inc..

48
Total
48
Cleared
131d
Avg days
1997
Since
48 devices
25–48 of 48
Cleared May 15, 2008
EZ MANAGER MAX DIABETES MANAGEMENT SOFTWARE
K080587
Animas Corp.
General Hospital · 73d
Cleared Feb 13, 2008
CADD-SENTRY PRO MEDICATION SAFETY SOFTWARE-ADMINISTRATOR (21-6275), POINT OF CARE (21-6276)
K072955
Smiths Medical MD, Inc.
General Hospital · 117d
Cleared Oct 17, 2007
MEDTRONIC MINIMED CARELINK USB CONNECTOR, MODEL NMT 7305
K070438
Medtronic Minimed, Inc.
General Hospital · 244d
Cleared Sep 04, 2007
DANA 3CC SYRINGE INSULIN RESERVOIR
K071418
Sooil Development Co., Ltd.
General Hospital · 105d
Cleared May 19, 2005
HOSPIRA GEMSTAR INFUSION PUMP SYSTEM WITH HOSPIRA GEMSTAR SPRING ASSIST MECHANISM LOCKBOX-7 THERAPY
K051079
Hospicare, Inc.
General Hospital · 22d
Cleared Aug 06, 2002
MEDTRONIC MINIMED COMLINK, HARDWARE MODEL 7304 & SOFTWARE MODEL 7311
K021974
Minimed, Inc.
General Hospital · 50d
Cleared Sep 12, 2001
MEDFUSION 2001 & 2010, MODEL N7215IWC
K012259
National Custom Ent., Inc.
General Hospital · 56d
Cleared Sep 12, 2001
BAXTER AS40A, AS41 SYRINGE PUMP, MODEL N61WC
K012262
National Custom Ent., Inc.
General Hospital · 56d
Cleared Sep 12, 2001
SHERWOOD 224, 324 FEEDING PUMP & K524 INTRI-FLUSH, MODEL N7213IWC2
K012266
National Custom Ent., Inc.
General Hospital · 56d
Cleared Apr 04, 1999
S.P.A.R STERILE AMBULATORY RESERVOIR
K990091
Faulding Pharmaceutical Co.
General Hospital · 83d
Cleared Apr 20, 1998
INFUTEST 2000 INFUSION DEVICE ANALYZER
K980165
Datrend Systems, Inc.
General Hospital · 94d
Cleared Apr 17, 1998
IVAC MEDSYSTEM III, INFUSION PUMP W/DRUG EDITING SOFTWARE KIT
K961486
Ivac Medical Systems
General Hospital · 732d
Cleared Jan 09, 1998
THE HARVARD LIBRARY
K970678
Harvard Apparatus, Inc.
General Hospital · 319d
Cleared Oct 20, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS3030-P
K972779
Alexander Mfg. Co.
General Hospital · 87d
Cleared Oct 20, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL625
K972780
Alexander Mfg. Co.
General Hospital · 87d
Cleared Jul 18, 1997
STERILE AMBULATORY RESERVOIR 60ML/100ML
K962159
Faulding Medical Device Co.
General Hospital · 409d
Cleared Jul 03, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS06224
K972089
Alexander Mfg. Co.
General Hospital · 29d
Cleared May 27, 1997
ALEXANDER MFG. RECHARGEABLE BATTERY (MODEL M7)
K970786
Alexander Mfg. Co.
General Hospital · 84d
Cleared May 27, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL4018
K971212
Alexander Mfg. Co.
General Hospital · 55d
Cleared May 27, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY # GL825-P
K971213
Alexander Mfg. Co.
General Hospital · 55d
Cleared May 27, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL825
K971234
Alexander Mfg. Co.
General Hospital · 55d
Cleared May 27, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL8108
K971237
Alexander Mfg. Co.
General Hospital · 55d