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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device pump, infusion
Regulation Description Infusion pump.
Product CodeFRN
Regulation Number 880.5725
Device Class 2


Premarket Reviews
ManufacturerDecision
3M AVI, INC.
  SUBSTANTIALLY EQUIVALENT 16
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 8
3M COMPANY, 3M HEALTH CARE
  SUBSTANTIALLY EQUIVALENT 16
A MIXED BAG CORP.
  SUBSTANTIALLY EQUIVALENT 1
A.Z.E. MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
A0KFUSION SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ABBOTT
  SUBSTANTIALLY EQUIVALENT 69
ABBOTT LABORATORIES
  SUBSTANTIALLY EQUIVALENT 66
ABBOTT LABORATORIES INC
  SUBSTANTIALLY EQUIVALENT 1
ACCESS / GOD LOVES YOU
  SUBSTANTIALLY EQUIVALENT 1
ADVANCED MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 22
AIR-SHIELDS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ALARIS MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 7
ALEXANDER MFG. CO.
  SUBSTANTIALLY EQUIVALENT 2
ALZA CORP.
  SUBSTANTIALLY EQUIVALENT 1
AMERICAN HOSPITAL SUPPLY CORP.
  SUBSTANTIALLY EQUIVALENT 7
AMERICAN I.V. PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
AMERICAN MCGAW
  SUBSTANTIALLY EQUIVALENT 1
AMERICAN MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
ANGIODYNAMICS, INC.
  SE SUBJECT TO TRACKING REG 1
APPLIED DIABETES RESEARCH, INC.
  SUBSTANTIALLY EQUIVALENT 1
APPLIED DIABETES RESEARCH, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
ARMAMENT SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ATRION CORP.
  SUBSTANTIALLY EQUIVALENT 2
AVI, INC.
  SUBSTANTIALLY EQUIVALENT 13
B. BRAUN MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 12
B. BRAUN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 13
BARD MEDSYSTEMS DIV.
  SUBSTANTIALLY EQUIVALENT 1
BAXA CORP.
  SUBSTANTIALLY EQUIVALENT 2
BAXA INFUSION SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 42
BAXTER HEALTHCARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 8
BAXTERHEALTHCARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
BAYER MEDICAL CARE INC.
  SUBSTANTIALLY EQUIVALENT 6
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
  SUBSTANTIALLY EQUIVALENT 14
BECTON DICKINSON CURLIN, LLC.
  SUBSTANTIALLY EQUIVALENT 1
BEL-ART PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
BELMONT INSTRUMENT CORP.
  SE SUBJECT TO TRACKING REG 1
  SUBSTANTIALLY EQUIVALENT 3
BELMONT INSTRUMENT CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
BIO MEDICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIONICA, INC.
  SUBSTANTIALLY EQUIVALENT 3
BIOSEARCH MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 3
BIOTEK INSTRUMENTS, INC.
  SE SUBJECT TO TRACKING REG 2
BRACCO DIAGNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 1
BREG INC
  SUBSTANTIALLY EQUIVALENT 2
BRIDGE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
BURRON MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
BYRON MEDICAL
  SE SUBJECT TO TRACKING REG 1
  SUBSTANTIALLY EQUIVALENT 2
C. R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 22
CAESAREA MEDICAL ELECTRONICS
  SUBSTANTIALLY EQUIVALENT 8
CAESAREA MEDICAL ELECTRONICS LTD.
  SUBSTANTIALLY EQUIVALENT 8
CANE S.R.I.
  SUBSTANTIALLY EQUIVALENT 2
CANE S.R.L.
  SUBSTANTIALLY EQUIVALENT 6
CANE SRL
  SUBSTANTIALLY EQUIVALENT 2
CARDIAC PACEMAKERS, INC.
  SUBSTANTIALLY EQUIVALENT 15
CARDINAL HEALTH
  SUBSTANTIALLY EQUIVALENT 6
CARDINAL HEALTH 303, INC.
  SUBSTANTIALLY EQUIVALENT 37
CAREFUSION 303, INC.
  SUBSTANTIALLY EQUIVALENT 2
CARIDAC PACEMAKERS, INC.
  SUBSTANTIALLY EQUIVALENT 1
CAROLINA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARTICEPT MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 4
CARTICEPT MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
CHATHAMBOROUGH RESEARCH GROUP, INC.
  SUBSTANTIALLY EQUIVALENT 1
CHURCHILL CORP.
  SUBSTANTIALLY EQUIVALENT 1
CLINICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
COMPAGNIE DE DEVELOPPEMENT AGUETTANT
  SUBSTANTIALLY EQUIVALENT 1
COMPASS INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 1
CONCERT MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 1
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 1
CORDIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
CORPAK CO.
  SE SUBJECT TO TRACKING REG 1
  SUBSTANTIALLY EQUIVALENT 1
CORPAK, INC.
  SE SUBJECT TO TRAKING & PMS 1
CPI, INC.
  SUBSTANTIALLY EQUIVALENT 1
CRITICARE TECHNOLOGIES CORP.
  SUBSTANTIALLY EQUIVALENT 1
CRITIKON COMPANY,LLC
  SUBSTANTIALLY EQUIVALENT 7
DALTEX MEDICAL SCIENCES, INC.
  SUBSTANTIALLY EQUIVALENT 1
DANBY MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 2
DEFINITIVE MEDICAL TECHNOLOGIES, LTD.
  SUBSTANTIALLY EQUIVALENT 1
DELMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
DELPHI MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
DELTA MEDICAL INDUSTRIES
  SUBSTANTIALLY EQUIVALENT 5
DELTEC SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 7
DIATEK, INC.
  SUBSTANTIALLY EQUIVALENT 2
DISETRONIC MEDICAL SYSTEMS
  SE SUBJECT TO TRACKING REG 3
  SUBSTANTIALLY EQUIVALENT 3
DISETRONIC MEDICAL SYSTEMS AG
  SUBSTANTIALLY EQUIVALENT 2
DISETRONIC MEDICAL SYSTEMS, INC.
  SE SUBJECT TO TRACKING REG 3
  SUBSTANTIALLY EQUIVALENT 5
DYNATECH MEDICAL PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
DYNATECH/NEVADA, INC.
  SUBSTANTIALLY EQUIVALENT 1
EGNELL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ELAN MEDICAL TECHNOLOGIES, LTD.
  SUBSTANTIALLY EQUIVALENT 2
ELECTROCHEMICAL DRUG DELIVERY, INC.
  SUBSTANTIALLY EQUIVALENT 2
ELIXIR CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
EMPIRE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
ENTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
ETHOX INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 3
EXCEL MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
E-Z-EM, INC.
  SUBSTANTIALLY EQUIVALENT 1
FERGUSON MEDICAL
  SUBSTANTIALLY EQUIVALENT 5
FERRING LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
FLUIDSENSE CORP
  SUBSTANTIALLY EQUIVALENT 2
FLUIDSENSE CORP.
  SUBSTANTIALLY EQUIVALENT 2
FRESENIUS
  SUBSTANTIALLY EQUIVALENT 1
FRESENIUS KABI AG
  SUBSTANTIALLY EQUIVALENT 1
FRESENIUS MEDICAL CARE NORTH AMERICA, DESIGN CENTE
  SUBSTANTIALLY EQUIVALENT 1
GAMBRO, INC.
  SUBSTANTIALLY EQUIVALENT 1
GO MEDICAL INDUSTRIES PTY. LTD.
  SUBSTANTIALLY EQUIVALENT 1
GRASEBY MEDICAL LTD.
  SE SUBJECT TO TRACKING REG 2
  SUBSTANTIALLY EQUIVALENT 2
GRIESHABER & CO.
  SUBSTANTIALLY EQUIVALENT 2
GUIDANT CORP
  SUBSTANTIALLY EQUIVALENT 8
HAEMONETICS CORP.
  SUBSTANTIALLY EQUIVALENT 2
HAEMONETICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
HALYARD HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 17
HARVARD APPARATUS FOUNDATION
  SUBSTANTIALLY EQUIVALENT 6
HARVARD APPARATUS, INC.
  SUBSTANTIALLY EQUIVALENT 6
HARVARD CLINICAL TECHNOLOGY
  SUBSTANTIALLY EQUIVALENT 1
HEALTHTEK, INC.
  SUBSTANTIALLY EQUIVALENT 1
HEDECO
  SUBSTANTIALLY EQUIVALENT 1
HELP TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 3
HIRATA SANGYO CO. USA, INC.
  SUBSTANTIALLY EQUIVALENT 3
HK SURGICAL
  SUBSTANTIALLY EQUIVALENT 2
HK SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
HOSPIRA, INC
  SUBSTANTIALLY EQUIVALENT 1
HOSPIRA, INC.
  SUBSTANTIALLY EQUIVALENT 12
I FLOW CORP
  SUBSTANTIALLY EQUIVALENT 13
IATRIC DEVICES
  SUBSTANTIALLY EQUIVALENT 1
ICU MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1
ICU MEDICAL SALES, INC.
  SUBSTANTIALLY EQUIVALENT 1
IMED CORP.
  SUBSTANTIALLY EQUIVALENT 22
IMED IRELAND, LTD.
  SUBSTANTIALLY EQUIVALENT 1
INFUCARE PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
INFUSION DYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
INFUSION SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 2
INFUSION TECHNOLOGY INTL.
  SUBSTANTIALLY EQUIVALENT 1
INTELLIGENT MEDICINE, INC.
  SUBSTANTIALLY EQUIVALENT 4
INTERMEDICS
  SUBSTANTIALLY EQUIVALENT 7
INTERNATIONAL MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
INTRABIONIC CO.
  SUBSTANTIALLY EQUIVALENT 2
INTRO-MED, INC.
  SUBSTANTIALLY EQUIVALENT 1
IRADIMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
ISYS MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
JOHNSON & JOHNSON CARDIOVASCULAR
  SUBSTANTIALLY EQUIVALENT 1
JOHNSON & JOHNSON INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 1
JONATHAN PRATT
  SUBSTANTIALLY EQUIVALENT 1
KALAJIAN ENT.
  SUBSTANTIALLY EQUIVALENT 1
KAWASUMI LABORATORIES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
KENDALL
  SUBSTANTIALLY EQUIVALENT 1
KOLSTER METHODS, INC.
  SUBSTANTIALLY EQUIVALENT 1
KOLSTER METHODS, INC. (KMI)
  SUBSTANTIALLY EQUIVALENT 1
MAMMENDORFER INSTITUTE FOR PHYSICS & MEDICINE GMBH
  SUBSTANTIALLY EQUIVALENT 1
MARQUETTE
  SUBSTANTIALLY EQUIVALENT 2
MARQUETTE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
MCGAW, INC.
  SUBSTANTIALLY EQUIVALENT 8
MCKINLEY MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
McKinley Medical, LLP
  SUBSTANTIALLY EQUIVALENT 3
MEDEX
  SE SUBJECT TO TRACKING REG 2
  SUBSTANTIALLY EQUIVALENT 4
MEDEX, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDFUSION SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDFUSION, INC.
  SUBSTANTIALLY EQUIVALENT 5
MEDICAL DELIVERY SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL TECHNICAL PRODUCTS, INC
  SUBSTANTIALLY EQUIVALENT 2
MEDICATION DELIVERY DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDIX CORP.
  SUBSTANTIALLY EQUIVALENT 1
MEDIX MEDICAL ELECTRONICS (U.S.A.), INC.
  SUBSTANTIALLY EQUIVALENT 5
MEDLOG GMBH MARKETING SERVICES
  SUBSTANTIALLY EQUIVALENT 1
MEDRAD, INC.
  SUBSTANTIALLY EQUIVALENT 6
MEDTRON DEVELOPMENT LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC INC.
  SUBSTANTIALLY EQUIVALENT 13
MEDTRONIC MINIMED
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 15
MENTOR O & O, INC.
  SUBSTANTIALLY EQUIVALENT 1
MENTOR WORLDWIDE LLC
  SE SUBJECT TO TRACKING REG 1
  SUBSTANTIALLY EQUIVALENT 2
METRON U.S., INC.
  SUBSTANTIALLY EQUIVALENT 1
METTLER ELECTRONICS
  SE SUBJECT TO TRACKING REG 1
METTLER ELECTRONICS CORP.
  SE SUBJECT TO TRACKING REG 1
MICREL MEDICAL DEVICES S.A.
  SUBSTANTIALLY EQUIVALENT 1
MINNESOTA MINING AND MFG. CO.
  SE SUBJECT TO TRACKING REG 1
MIRA, INC.
  SUBSTANTIALLY EQUIVALENT 1
NARCO SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
NIHON KOHDEN CORP.
  SUBSTANTIALLY EQUIVALENT 1
NORDISK INFUSER SYSTEM
  SUBSTANTIALLY EQUIVALENT 1
NORFOLK MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
NORFOLK MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
NOUVAG AG
  SUBSTANTIALLY EQUIVALENT 1
NU TECH MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
NUMIA MEDICAL TECHNOLOGY, LLC
  SUBSTANTIALLY EQUIVALENT 1
OHIO MEDICAL PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
OHMEDA MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
OMNI-FLOW, INC.
  SUBSTANTIALLY EQUIVALENT 1
OMNI-GLOW, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORANGE MEDICAL INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORTHO PHARMACEUTICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
ORTHOFIX
  SUBSTANTIALLY EQUIVALENT 2
PACESETTER SYSTEMS
  SUBSTANTIALLY EQUIVALENT 7
PANAMEDIX, INC.
  SUBSTANTIALLY EQUIVALENT 1
PANCRETEC, INC.
  SUBSTANTIALLY EQUIVALENT 7
PATIENT SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
  SE SUBJECT TO TRACKING REG 2
PEREGRINE SURGICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
PFIZER
  SUBSTANTIALLY EQUIVALENT 11
PHADIA AB
  SUBSTANTIALLY EQUIVALENT 1
PHARMACEUTICAL INFUSION TECHNOLOGIES, INC.
  SE SUBJECT TO TRACKING REG 1
PHARMACIA DELTEC, INC.
  SE SUBJECT TO TRACKING REG 1
  SUBSTANTIALLY EQUIVALENT 9
PINKERTON OPTICAL CORP.
  SE SUBJECT TO TRACKING REG 2
  SUBSTANTIALLY EQUIVALENT 4
PORTABLE POWER SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
PP HOLDING, INC.
  SUBSTANTIALLY EQUIVALENT 2
PRECISION FLUIDICS DIVISION PARKER HANNIFIN CORP.
  SUBSTANTIALLY EQUIVALENT 4
PRINCETON MEDICAL INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
PRN SERVICES, INC.
  SUBSTANTIALLY EQUIVALENT 2
PROGRESS MANKIND TECHNOLOGY
  SUBSTANTIALLY EQUIVALENT 1
PROMEDIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
Q CORE MEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 2
Q-CORE, LTD
  SUBSTANTIALLY EQUIVALENT 1
Q-LIFE SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
QUEST MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
RAZEL SCIENTIFIC INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
RELIANCE MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
REPRO-MED SYSTEMS, INC.
  SE SUBJECT TO TRACKING REG 1
  SUBSTANTIALLY EQUIVALENT 1
RICHARD JAMES, INC.
  SUBSTANTIALLY EQUIVALENT 1
RIVER MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
  SE SUBJECT TO TRACKING REG 3
ROBERT W. KALAYJIAN, M.D.
  SUBSTANTIALLY EQUIVALENT 1
ROCHE MEDICAL ELECTRONICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SABRATEK
  SUBSTANTIALLY EQUIVALENT 4
SCIENCE INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
SGARLATO LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
SHERWOOD MEDICAL CO.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS INFUSIONS SYSTEMS
  SE SUBJECT TO TRACKING REG 1
SIGMA
  SUBSTANTIALLY EQUIVALENT 6
SIGMA INTL. GENERAL MEDICAL APPARATUS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SIGMAMOTOR, INC.
  SUBSTANTIALLY EQUIVALENT 3
SIMS
  SUBSTANTIALLY EQUIVALENT 1
SMASH ENT., INC.
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SE SUBJECT TO TRACKING REG 1
  SUBSTANTIALLY EQUIVALENT 1
SMITHS
  SUBSTANTIALLY EQUIVALENT 12
SMITHS GROUP PLC
  SUBSTANTIALLY EQUIVALENT 5
SORENSON DEVELOPMENT, INC.
  SUBSTANTIALLY EQUIVALENT 1
SORENSON MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 4
SPECTRX, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPIESS DESIGN, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPINTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
SQUIBB DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 2
STERLING MEDICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 2
STERLING MEDIVATIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
STEWART-NAUMANN LABORATORIES
  SUBSTANTIALLY EQUIVALENT 1
STRATO MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 6
STRYKER
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 7
STUMARK CORP.
  SUBSTANTIALLY EQUIVALENT 1
SUNRISE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
SUNRISE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SUPERIOR PLASTIC PRODUCTS CORP.
  SUBSTANTIALLY EQUIVALENT 1
SURGIDEV CORP.
  SUBSTANTIALLY EQUIVALENT 1
SYNERGETICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
TECHNOLOGY TRANSFER INTL., INC.
  SUBSTANTIALLY EQUIVALENT 4
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
TERUMO MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
THE ANSPACH EFFORT, INC.
  SUBSTANTIALLY EQUIVALENT 1
THE OFFENBACK CO.
  SUBSTANTIALLY EQUIVALENT 1
TRAVENOL LABORATORIES, S.A.
  SUBSTANTIALLY EQUIVALENT 23
UNILEVER UNITED STATES, INC.
  SUBSTANTIALLY EQUIVALENT 1
UNIVERSAL MEDICAL TECHNOLOGIES INC
  SUBSTANTIALLY EQUIVALENT 1
VALLEY WEST, INC.
  SUBSTANTIALLY EQUIVALENT 2
VALLEYLAB
  SUBSTANTIALLY EQUIVALENT 7
VEINNOVATIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1
VIAL MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 2
VICKERS AMERICA MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 2
VICKERS LTD.
  SUBSTANTIALLY EQUIVALENT 2
VILTECHMEDA
  SUBSTANTIALLY EQUIVALENT 1
VITAL CANADA, INC.
  SUBSTANTIALLY EQUIVALENT 1
VITAL RESOURCES CORP.
  SUBSTANTIALLY EQUIVALENT 1
WALKMED INFUSION LLC
  SUBSTANTIALLY EQUIVALENT 3
WELLS JOHNSON CO.
  SUBSTANTIALLY EQUIVALENT 1
WINDSOR MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 8
ZIEHM INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 4
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 3
ZOLL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ZYNO MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 4
ZYNO MEDICAL LLC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device displays error message 8191
Break 4475
Device inoperable 3361
Excess flow or overinfusion 2776
Component(s), broken 2454
Failure to sense 2221
Battery failure 1698
Infusion or flow issue 1673
Device operates differently than expected 1658
Insufficient flow or underinfusion 1567
Not audible alarm 1437
Fluid leak 988
Failure to deliver 862
Battery issue 800
Shielding failure 796
Device alarm system issue 714
Defective component 700
Occlusion within device 543
Overheating of device or device component 540
Inaccurate flowrate 440
Foreign material present in device 435
Improper flow or infusion 430
Alarm, audible 423
Free or unrestricted flow 404
Loss of power 324
No Known Device Problem 275
Pumping stopped 269
Leak 268
False alarm 246
Inaccurate delivery 232
Air leak 223
Use of Device Issue 210
Overdelivery 205
Bent 205
Spark 193
Burn of device or device component 190
Disconnection 178
Failure to power-up 172
Material rupture 168
Crack 167
Sticking 162
Material separation 158
Calibration error 130
Filling problem 126
Volume accuracy issue 126
Smoking 122
Charred 118
No display or display failure 114
Underdelivery 105
Failure to infuse 101
Mechanical issue 96
Incorrect software programming calculations 90
Communication or transmission issue 89
Self-activation or keying 88
Failure to prime 84
No flow 81
Inadequate user interface 80
Loose or intermittent connection 77
Nonstandard device or device component 75
No code available 75
No Information 74
Electrical issue 72
Particulates 68
Pumping issue 66
Fire 65
Calibration issue 63
Protective measure issue 63
Reflux within device 59
Component missing 56
Incorrect or inadequate result 55
Melted 55
Malfunction 53
Device stops intermittently 52
Pressure sensor failure 52
Moisture damage 50
Power source issue 50
Positioning Issue 49
Defective Alarm 47
Bubble detector, failure of 46
Device Issue 45
Fail-safe mechanism issue 44
Mechanical jam 43
Low readings 42
Incorrect display 41
Image display error 41
Retraction problem 40
Low battery 39
Programming issue 39
Connection issue 37
Unknown (for use when the device problem is not known) 37
Improper alarm 35
Improper or incorrect procedure or method 34
Difficult to open or close 32
Hole in material 31
Device sensing issue 30
Other (for use when an appropriate device code cannot be identified) 30
Device or device component damaged by another device 29
Material deformation 27
Accuracy rate 27
Material puncture 26
Total Device Problems 47052

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018
Class I 3 1 2 7 4 8 8 5 3 0 1 0
Class II 6 9 10 9 20 14 17 11 8 17 14 4
Class III 1 0 0 0 1 2 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Angiodynamics, INC II Nov-17-2010
2 B Braun Medical, Inc I Oct-18-2011
3 B Braun Medical, Inc II Oct-03-2011
4 B Braun Medical, Inc I Jan-10-2011
5 B Braun Medical, Inc. I Sep-13-2013
6 B Braun Medical, Inc. II Sep-10-2013
7 B Braun Medical, Inc. II Sep-06-2013
8 B Braun Medical, Inc. II Sep-06-2013
9 B. Braun Medical, Inc. II Sep-06-2013
10 B. Braun Medical, Inc. II Dec-31-2012
11 B. Braun Medical, Inc. I Jul-16-2012
12 B. Braun Medical, Inc. I Feb-29-2012
13 B. Braun Medical, Inc. II Sep-23-2008
14 Baxter Healthcare Corp II Apr-16-2015
15 Baxter Healthcare Corp. II Nov-29-2016
16 Baxter Healthcare Corp. II Oct-01-2014
17 Baxter Healthcare Corp. I Apr-25-2014
18 Baxter Healthcare Corp. II Nov-08-2013
19 Baxter Healthcare Corp. II Nov-08-2013
20 Baxter Healthcare Corp. II Jun-27-2013
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