Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Pump, Infusion

FDA product code FRN · 840 cleared devices

Class 2 General Hospital

Regulation: 21 CFR 880.5725
Review panel: HO
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1976-08-23 – 2026-07-24

FRN 2005-12-08

AMBIT PUSH & PLAY AMBULATORY INFUSION PUMP

Applicant Sorenson Medical, Inc.

K number K052221

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FRN 2005-11-23

CRONO FIVE AND CRONO PCA 50

Applicant Cane S.R.L.

K number K052218

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FRN 2005-11-23

NIKI T34 AND BODYGUARD T34 SYRINGE DRIVERS

Applicant Caesarea Medical Electronics , Ltd.

K number K050800

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FRN 2005-11-17

CADD-MS 3 AMBULATORY INFUSION PUMP

Applicant Smiths Medical MD, Inc.

K number K051568

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FRN 2005-10-20

ALARIS SYSTEM PC UNIT, MODEL 8001

Applicant Cardinal Health, Alaris Products

K number K051641

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FRN 2005-10-13

ZIMMER AMBULATORY PUMP PAIN MANAGEMENT SYSTEM WITH PATIENT CONTROL MODULE

Applicant Zimmer, Inc.

K number K052171

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FRN 2005-09-13

CRONO GO.

Applicant Cane S.R.L.

K number K052219

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FRN 2005-09-13

CRONO SUPER PID

Applicant Cane S.R.L.

K number K052217

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FRN 2005-08-24

HOSPIRA PLUM A+ INFUSION PUMP SYSTEM V11.5, HOSPIRA PLUM A+ 3 INFUSION PUMP SYSTEM, V11.5

Applicant Hospira, Inc.

K number K052052

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FRN 2005-08-02

SIMPLECHOICE 3.0 ML RESERVOIR PRO REFERENCE NUMBER RP-30

Applicant Spectrx, Inc.

K number K051045

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FRN 2005-05-27

MICROPUMP MP-101

Applicant Micrel Medical Devices S.A.

K number K051252

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FRN 2005-05-10

PAINPUMP2

Applicant Stryker Instruments

K number K043466

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FRN 2005-04-27

INFPUMP INFILTRATION PUMP

Applicant Carolina Medical, Inc.

K number K050324

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FRN 2005-04-14

VEINNOVATIONS INFILTRATION SYSTEM

Applicant Veinnovations, LLC

K number K050474

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FRN 2005-04-13

ZIMMER AMBULATORY PUMP PAIN MANAGEMENT SYSTEM

Applicant Zimmer Orthopaedic Surgical Products

K number K050433

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FRN 2005-03-30

SGARLATO LABS PAINFREE PUMP AND PAIN CONTROL INFUSION PUMP

Applicant Sgarlato Laboratories, Inc.

K number K043204

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FRN 2005-03-29

MEDTRONIC MICROMED 407C INFUSION PUMP, MODEL MMT-407C

Applicant Medtronic Minimed

K number K043600

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FRN 2005-03-25

SE INFUSION SYSTEM WITH MMS

Applicant Cardinal Health, Alaris Products

K number K043590

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FRN 2005-03-24

MRIDIUM 3850 MRI PUMP SYSTEM

Applicant Iradimed Corporation

K number K050301

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FRN 2005-03-11

BODYGUARD INFUSION PUMP SYSTEM

Applicant Caesarea Medical Electronics , Ltd.

K number K042696

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FRN 2005-02-11

HARVARD 2 SYRINGE PUMP, MODEL 2001-001

Applicant Harvard Clinical Technology

K number K050107

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FRN 2005-01-04

PHARMGUARD TOOLBOX, MODEL G6000782

Applicant Medex, Inc.

K number K042432

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FRN 2004-11-30

PUMP CONNECTIVITY INTERFACE

Applicant Baxter Healthcare Corp

K number K040985

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FRN 2004-11-17

HOSPIRA GEMSTAR INFUSION PUMP SYSTEM, HOSPIRA GEMSTAR CONNECT SOFTWARE

Applicant Hospira, Inc.

K number K042980

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FRN 2004-11-08

BEELINE MOTIV, PROPOLIS, PCA

Applicant Mckinley, Inc.

K number K042228

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FRN 2004-10-14

PAINPUMP1; PAINPUMP2

Applicant Stryker Corp.

K number K042405

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FRN 2004-10-06

HOSPIRA MEDNET MEDICATION MANAGEMENT SUITE

Applicant Hospira, Inc.

K number K042609

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FRN 2004-10-01

E-PAIN CARE

Applicant Breg, Inc.

K number K041714

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FRN 2004-09-17

CRONO F

Applicant Cane S.R.L.

K number K042085

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FRN 2004-08-26

SPECTRUM AND SPECTRUM WITH MASTER DRUG LIBRARY

Applicant Sigma Intl.

K number K042121

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FRN 2004-08-24

PLUM A+ INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE , AND PLUM A+3 INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE

Applicant Hospira, Inc.

K number K042081

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FRN 2004-07-09

BAXTER INFUSOR SV (SMALL VOLUME); BAXTER INFUSOR LV (LARGE VOLUME)

Applicant Baxter Healthcare Corporation

K number K041738

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FRN 2004-07-08

CRONO AND CRONO, MODEL 30

Applicant Cane S.R.L.

K number K041414

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FRN 2004-07-06

MEDLEY SYSTEM WITH BAR CODE MODULE, MODEL 8600

Applicant Alaris Medical Systems, Inc.

K number K041241

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FRN 2004-06-30

HOSPIRA PHOENIX INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE

Applicant Abbott Laboratories

K number K041550

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FRN 2004-06-25

COLLEAGUE VOLUMETRIC INFUSION PUMPS

Applicant Baxter Healthcare Corp

K number K041191

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FRN 2004-06-03

PSI-TEC PERISTALTIC INFILTRATION PUMP

Applicant Byron Medical

K number K040149

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FRN 2004-05-24

THINSET 1.8 ML RESERVOIR, MODEL 326A; THINSET 3.0 ML RESERVOIR, MODEL 332A

Applicant Applied Diabetes Research, Inc.

K number K041152

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FRN 2004-04-30

MEDEX 3000 SERIES MR SYRINGE INFUSION PUMP

Applicant Medex, Inc.

K number K040899

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FRN 2004-04-08

MEDTRONIC MINIMED MMT-407C AMBULATORY INFUSION PUMP, MODEL MMT-407C

Applicant Medtronic Minimed

K number K040061

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FRN 2004-01-29

ABBOTT DATA PORT PC, MODEL 12181

Applicant Abbott Laboratories

K number K040114

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FRN 2004-01-14

INFUSION DYNAMICS (ID) POWER INFUSER, MODEL M100B-3A WITH BLOOD CARTRIDGE

Applicant Infusion Dynamics, Inc.

K number K030739

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FRN 2003-11-06

AMBIT INTERMITTENT AMBULATORY INFUSION PUMP

Applicant Sorenson Medical, Inc.

K number K033425

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FRN 2003-11-06

AMBIT CONTINUOUS AMBULATORY INFUSION PUMP

Applicant Sorenson Medical, Inc.

K number K033325

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FRN 2003-10-09

REPLACEMENT PUMP HEAD DOOR ASSEMBLY, P1, MODEL BX10468, REPLACEMENT PUMP HEAD DOOR ASSEMBLY, P2, MODEL BX10469

Applicant American I.V. Products, Inc.

K number K032789

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FRN 2003-09-23

MEDRAD CONTINUUM MR INFUSION SYSTEM

Applicant Medrad, Inc.

K number K032771

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FRN 2003-09-23

BEELINE SYSTEM

Applicant Mckinley, Inc.

K number K032642

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FRN 2003-08-22

MEDTRONIC MINIMED PARADIGM RESERVOIR, MODEL MMT-332

Applicant Medtronic Minimed

K number K032005

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FRN 2003-08-21

BODYGUARD INFUSION SYSTEM

Applicant Caesarea Medical Electronics , Ltd.

K number K031749

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FRN 2003-08-13

CONDUCTION CATHETER

Applicant Micor, Inc.

K number K031600

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FRN 2003-08-07

KLEIN SURGICAL INFILTRATION PUMP, MODEL KIP-II

Applicant Hk Surgical, Inc.

K number K031432

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FRN 2003-07-25

SIGNATURE EDITION INFUSION PUMP, SIGNATURE EDITION ADMINISTRATION SETS, MODELS 70XX, 71XX, 72XX, 7XXXX SERIES

Applicant Alaris Medical Systems, Inc.

K number K032147

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FRN 2003-07-21

MODIFICATION TO STRYKER PAINPUMP

Applicant Stryker Instruments

K number K031249

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FRN 2003-05-21

ANSPACH IRRIGATION PUMP AND IRRIGATION PUMP II

Applicant The Anspach Effort, Inc.

K number K030576

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FRN 2003-04-30

ABBOTT PLUM A+ INFUSION PUMP WITH A HPL/RS PLUG-AND-PLAY MODULE

Applicant Abbott Laboratories

K number K031185

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FRN 2003-04-18

MODIFICATION TO STRYKER PAINPUMP2

Applicant Stryker Instruments

K number K030885

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FRN 2003-04-04

MEDLEY SYSTEM WITH MEDICATION MANAGEMENT SYSTEM (MMS)

Applicant Alaris Medical Systems, Inc.

K number K030459

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FRN 2003-04-02

MRI-CADDY

Applicant Mammendorfer Institute For Physics & Medicine GmbH

K number K030323

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FRN 2003-03-20

VISTA BASIC WITH FM SYSTEM

Applicant B.Braun Medical, Inc.

K number K023189

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FRN 2003-03-17

FENESTRATED INFUSION CATHETER

Applicant Promedic, Inc.

K number K024190

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FRN 2003-02-28

SILBERG T.P.S., TISSUE PREPARATION SYSTEM, MODEL ME 800

Applicant Mettler Electronics Corp.

K number K023083

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FRN 2003-02-27

AUTOMED 3200 INFUSION PUMP

Applicant Help Technologies

K number K023973

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FRN 2003-02-07

AUTOMED 3000 INFUSION PUMP

Applicant Help Technologies

K number K023863

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FRN 2003-01-17

SURESET 3.0 ML RESERVOIR, MODEL 24-103

Applicant Applied Diabetes Research, Incorporated

K number K024056

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FRN 2002-12-31

ABBOTT PLUM A+ INFUSION PUMP, MODEL 12391

Applicant Abbott Laboratories

K number K024084

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FRN 2002-12-19

MEDLEY SYRINGE PUMP MODULE SYSTEM, MODEL 8110

Applicant Alaris Medical Systems, Inc.

K number K023264

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FRN 2002-12-13

PARAGON INFUSION SYSTEM WITH BOLUS

Applicant I-Flow Corp.

K number K023827

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FRN 2002-12-13

AUTOMED 3300 AND 3400 INFUSION PUMP SYSTEM

Applicant Help Technologies

K number K023491

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FRN 2002-09-30

GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, 6 THERAPY & PAIN MANAGEMENT

Applicant Abbott Laboratories, Inc.

K number K023062

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FRN 2002-09-20

SOAKER CATHETER

Applicant I-Flow Corp.

K number K022869

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FRN 2002-08-29

MEDRAD CONTINUUM MR COMPATIBLE INFUSION SYSTEM

Applicant Medrad, Inc.

K number K021988

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FRN 2002-08-21

PERFUSOR COMPACT WITH FM SYSTEM

Applicant B.Braun Medical, Inc.

K number K022575

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FRN 2002-05-14

ABBOTT PLUM A+3 MULTICHANNEL INFUSION PUMP, MODEL 12348

Applicant Abbott Laboratories

K number K021350

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FRN 2002-05-14

MICROJET CRONO PAR AND CRONO APO-GO

Applicant Cane S.R.L.

K number K013840

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FRN 2002-05-09

MICROJET CRONO H

Applicant Cane S.R.I.

K number K013855

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FRN 2002-04-26

MICROJET MODEL # CD4 AND CD4/20

Applicant Cane S.R.I.

K number K013776

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FRN 2002-04-26

MICROJET CRONO

Applicant Cane S.R.L.

K number K013234

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FRN 2002-04-17

MODIFICATION TO DYONICS INTELIJET REUSABLE CANNULAS

Applicant Smith & Nephew, Inc.

K number K020947

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FRN 2002-03-27

MODIFICATION TO PERSONAL INFUSOR LOCAL PAIN MANAGEMENT PROCEDURAL KIT

Applicant Science Incorporated

K number K020881

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FRN 2002-02-15

PARAGON INFUSION SYSTEM

Applicant I-Flow Corp.

K number K020251

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FRN 2001-12-31

STRYKER PAINPUMP

Applicant Stryker Corp.

K number K014091

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FRN 2001-12-12

SIMPLICITY INFUSION RESERVOIR FOR USE TO INFUSE MEDICINE, INCLUDING INSULIN, FROM AN EXTERNAL INFUSION PUMP

Applicant Sterling Medivations, Inc.

K number K013767

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FRN 2001-10-02

GEMINI PC-1,PC-2, PC-2TX,PC-4, SIGNATURE EDITION INFUSION PUMP (SE), MEDSYSTEM III INFUSION (MSIII), MEDSYSTEM PATIENT C

Applicant Alaris Medical Systems, Inc.

K number K012383

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FRN 2001-09-19

HORIZON OUTLOOK WITH DOSECOM

Applicant B.Braun Medical, Inc.

K number K011975

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FRN 2001-08-28

BI-PHASIC INFILTRATOR

Applicant Reliance Medical Corp.

K number K012044

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FRN 2001-07-17

WUNDCATH CONDUCTION CATHETER

Applicant Micor, Inc.

K number K003966

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FRN 2001-06-25

SEP-10S PLUS, AND SP-12S PRO.

Applicant Viltechmeda

K number K010937

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FRN 2001-06-05

ABBOTT PLUM A+INFUSION PUMP, MODEL 11971

Applicant Abbott Laboratories

K number K011442

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FRN 2001-06-05

STRYKER PAINPUMP PCA

Applicant Stryker Instruments

K number K003543

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FRN 2001-05-15

COLLEAGUE VOLUMETRIC INFUSION PUMP

Applicant Baxter Healthcare Corp

K number K010566

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FRN 2001-05-01

ABBOTT ACCLAIM ENCORE, MODEL 12237

Applicant Abbott Laboratories

K number K011096

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FRN 2001-04-06

MODIFICATION TO PLUM XL INFUSION PUMP

Applicant Abbott Laboratories

K number K010924

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FRN 2000-12-13

PAIN CARE MULTI-PORT CATHETER, MODEL 2000L

Applicant Breg, Inc.

K number K003611

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FRN 2000-12-12

COLLEAGUE (3CX, 3, CX) VOLUMETRIC INFUSION PUMP

Applicant Baxter Healthcare Corp

K number K003616

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FRN 2000-12-05

FLUIDSENSE FLUID DELIVERY SYSTEM MODEL FS-01

Applicant Fluidsense Corp.

K number K003582

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FRN 2000-12-04

INFUSOMAT P

Applicant B.Braun Medical, Inc.

K number K003029

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FRN 2000-09-18

6060 MULTI-THERAPY PUMP, MODEL 2M9832; 6060 EPIDURAL PUMP, MODEL 2L9351

Applicant Baxter Healthcare Corp

K number K002679

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FRN 2000-09-05

INFUSOR SV, INFUSOR LV, BAXTER PAIN MANAGEMENT SYSTEM

Applicant Baxter Healthcare Corp

K number K002380

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FRN 2000-08-18

MINIMED PARADIGM INSULIN PUMP, MODEL 511

Applicant Minimed, Inc.

K number K001829

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FRN 2000-08-18

PARADIGM 1.5ML RESERVOIR, MODEL 326

Applicant Minimed, Inc.

K number K001828

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