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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device electrosurgical, cutting & coagulation & accessories
Regulation Description Electrosurgical cutting and coagulation device and accessories.
Product CodeGEI
Regulation Number 878.4400
Device Class 2


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 5
A&E
  SUBSTANTIALLY EQUIVALENT 6
AARON MEDICAL
  SUBSTANTIALLY EQUIVALENT 27
ACMI CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
AESCULAP
  SUBSTANTIALLY EQUIVALENT 15
ALLIANCE MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
ALMA LASERS LTD.
  SUBSTANTIALLY EQUIVALENT 2
ALPHA SOURCE, INC
  SUBSTANTIALLY EQUIVALENT 2
AMERICAN BIOSURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
AMERICAN MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ANGIODYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
APPLIED MEDICAL RESOURCES CORP.
  SUBSTANTIALLY EQUIVALENT 11
ARAGON SURGICAL INC.
  SUBSTANTIALLY EQUIVALENT 4
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 2
ARTHROCARE CORP.
  SUBSTANTIALLY EQUIVALENT 76
ASCENT HEALTHCARE SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
ASPEN LABORATORIES
  SUBSTANTIALLY EQUIVALENT 26
ASPEN SURGICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ATRICURE, INC.
  SUBSTANTIALLY EQUIVALENT 4
BALLARD MEDICAL PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
BARRX MEDICAL, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 15
BAYLIS MEDICAL CO., INC.
  SUBSTANTIALLY EQUIVALENT 6
BEI MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
BERCHTOLD CORP.
  SUBSTANTIALLY EQUIVALENT 4
BIO PROTECH, INC.
  SUBSTANTIALLY EQUIVALENT 4
BIO-MEDICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
BLACK & BLACK SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 16
BOVIE
  SUBSTANTIALLY EQUIVALENT 8
BYRON MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 11
CAMERON-MILLER, INC.
  SUBSTANTIALLY EQUIVALENT 10
CARDINAL HEALTH
  SUBSTANTIALLY EQUIVALENT 3
CELON AG MEDICAL INSTRUMENTS
  SUBSTANTIALLY EQUIVALENT 2
CODMAN & SHURTLEFF, INC.
  SUBSTANTIALLY EQUIVALENT 5
CONMED
  SUBSTANTIALLY EQUIVALENT 61
CONTOUR FABRICATORS, INC.
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 6
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 17
CRYOGEN, INC.
  SE - WITH LIMITATIONS 1
CURON MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 7
DEROYAL
  SUBSTANTIALLY EQUIVALENT 3
ELECTROMEDICS CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
ELLMAN INT'L INC.
  SUBSTANTIALLY EQUIVALENT 20
ELMED
  SUBSTANTIALLY EQUIVALENT 6
EMCISION, LTD.
  SUBSTANTIALLY EQUIVALENT 6
ENCISION, INC.
  SUBSTANTIALLY EQUIVALENT 8
ENDIUS, INC.
  SUBSTANTIALLY EQUIVALENT 2
ENDOCARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
ENDYMION MEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 2
ENERGIST, LTD.
  SUBSTANTIALLY EQUIVALENT 1
ERBE ELEKTROMEDIZIN GMBH
  SUBSTANTIALLY EQUIVALENT 28
ETHICON
  SUBSTANTIALLY EQUIVALENT 25
FUSION MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
GALIL MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
GENICON
  SUBSTANTIALLY EQUIVALENT 2
GUIDANT CORP
  SUBSTANTIALLY EQUIVALENT 3
GYRUS ACMI, INC.
  SUBSTANTIALLY EQUIVALENT 29
HALT MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1
HEARTPORT, INC.
  SUBSTANTIALLY EQUIVALENT 1
HOGAN & HARTSON L.L.P.
  SUBSTANTIALLY EQUIVALENT 1
I.C. MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 6
INTERMEDICS
  SUBSTANTIALLY EQUIVALENT 2
INTUITIVE SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
INVASIX LTD.
  SUBSTANTIALLY EQUIVALENT 1
ION MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
ISKRA MEDICAL, D.O.O.
  SUBSTANTIALLY EQUIVALENT 1
J. JAMNER
  SUBSTANTIALLY EQUIVALENT 2
JEISYS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 5
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 13
KIRWAN SURGICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 10
KLS MARTIN GMBH + CO. KG
  SUBSTANTIALLY EQUIVALENT 1
LEONHARD LANG GMBH
  SUBSTANTIALLY EQUIVALENT 3
LINA MEDICAL APS
  SUBSTANTIALLY EQUIVALENT 5
LINEMASTER SWITCH CORP.
  SUBSTANTIALLY EQUIVALENT 1
LINVATEC
  SUBSTANTIALLY EQUIVALENT 6
LIVE TISSUE CONNECT, INC.
  SUBSTANTIALLY EQUIVALENT 1
LUMENIS, INC.
  SUBSTANTIALLY EQUIVALENT 1
LUTRONIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
MAQUET, INC.
  SUBSTANTIALLY EQUIVALENT 4
MAXXIM MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
MECTRA LABS, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
MEDISISS
  SUBSTANTIALLY EQUIVALENT 2
MEDLINE
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 11
MEGADYNE MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 29
MICROLINE PENTAX, INC.
  SUBSTANTIALLY EQUIVALENT 7
MINI LAP TECHNOLOGIES INC.
  SUBSTANTIALLY EQUIVALENT 1
MISONIX, INC.
  SUBSTANTIALLY EQUIVALENT 1
MITEK
  SUBSTANTIALLY EQUIVALENT 4
MODERN MEDICAL EQUIPMENT MFG., LTD.
  SUBSTANTIALLY EQUIVALENT 8
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 2
NCONTACT SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
NEOMEDIX CORP.
  SUBSTANTIALLY EQUIVALENT 3
NEOTHERMIA
  SUBSTANTIALLY EQUIVALENT 6
NEW DEANTRONICS TAIWAN, LTD.
  SUBSTANTIALLY EQUIVALENT 8
NORTHGATE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 3
NOVASYS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
OLSEN MEDICAL
  SUBSTANTIALLY EQUIVALENT 4
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 13
ORTHO DEVELOPMENT
  SUBSTANTIALLY EQUIVALENT 2
ORTHOPEDIC SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
PAJUNK GMBH
  SUBSTANTIALLY EQUIVALENT 3
PATTON SURGICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
PEAK SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 7
PILLING WECK
  SUBSTANTIALLY EQUIVALENT 2
PIONEER
  SUBSTANTIALLY EQUIVALENT 1
POREX SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
PRO-MED INSTRUMENTS GMBH
  SUBSTANTIALLY EQUIVALENT 1
Q2 MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
RADIOTHERAPEUTICS
  SE - WITH LIMITATIONS 1
  SUBSTANTIALLY EQUIVALENT 9
RHYTEC
  SUBSTANTIALLY EQUIVALENT 5
RICHARD WOLF
  SUBSTANTIALLY EQUIVALENT 11
RITA MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 14
RUBICOR MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 6
RUDOLF STORZ GMBH
  SUBSTANTIALLY EQUIVALENT 1
RZ MEDIZINTECHNIK GMBH
  SUBSTANTIALLY EQUIVALENT 1
SALIENT TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 2
SENORX, INC.
  SUBSTANTIALLY EQUIVALENT 6
SIEMENS
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 31
SOLOS ENDOSCOPY, INC
  SUBSTANTIALLY EQUIVALENT 4
SOMNUS MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 16
SORIN
  SUBSTANTIALLY EQUIVALENT 1
STARION INSTRUMENTS
  SUBSTANTIALLY EQUIVALENT 6
STELLARTECH RESEARCH CORP.
  SUBSTANTIALLY EQUIVALENT 11
STERILMED
  SUBSTANTIALLY EQUIVALENT 1
STINGRAY SURGICAL PRODUCTS, INC
  SUBSTANTIALLY EQUIVALENT 2
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 19
SURGICAL LASER TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
SURGRX, INC.
  SUBSTANTIALLY EQUIVALENT 8
SUTTER MEDIZINTECHNIK GMBH
  SUBSTANTIALLY EQUIVALENT 3
Symbiosis Corp.
  SUBSTANTIALLY EQUIVALENT 5
SYNERGETICS, INC.
  SUBSTANTIALLY EQUIVALENT 3
SYNERON
  SUBSTANTIALLY EQUIVALENT 4
TECNO INSTRUMENTS (PVT.) LTD.
  SUBSTANTIALLY EQUIVALENT 2
TELEFLEX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 2
THERMAGE, INC.
  SUBSTANTIALLY EQUIVALENT 17
THERMOSURGERY TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
TISSUELINK MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 12
TRANSAMERICAN TECHNOLOGIES INTL.
  SUBSTANTIALLY EQUIVALENT 1
TROD MEDICAL SA
  SUBSTANTIALLY EQUIVALENT 1
TROKAMED GMBH
  SUBSTANTIALLY EQUIVALENT 1
UNITED STATES SURGICAL
  SUBSTANTIALLY EQUIVALENT 5
UROLOGIX
  SUBSTANTIALLY EQUIVALENT 1
UTAH MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 3
VALLEYLAB
  SUBSTANTIALLY EQUIVALENT 71
VANGUARD MEDICAL CONCEPTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
VIDAMED, INC.
  SUBSTANTIALLY EQUIVALENT 7
VNUS MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 9
W. LORENZ SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
WALLACH SURGICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 3
WARNER-LAMBERT CO.
  SUBSTANTIALLY EQUIVALENT 1
XODUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
XOMED, INC.
  SUBSTANTIALLY EQUIVALENT 3
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 4

Device Problems
Break 3091
No Known Device Problem 642
Device displays error message 579
Detachment of device component 496
Device operates differently than expected 408
Unknown (for use when the device problem is not known) 403
Other (for use when an appropriate device code cannot be identified) 358
Peeled 299
Tip breakage 292
Difficult to open or close 289
Device remains activated 259
Replace 239
Device inoperable 225
Failure to deliver energy 213
No Information 203
Energy output to patient tissue incorrect 190
Electrical issue 188
Spark 186
Detachment of device or device component 177
Melted 147
Component(s), broken 146
Bent 146
Material deformation 145
Self-activation or keying 144
Device Issue 129
Burn of device or device component 118
Sticking 108
Mechanical issue 106
Failure to cut 86
No code available 84
Output issue 81
Dislodged or dislocated 78
Burst 77
Crack 77
Arcing 71
Use of Device Issue 71
Fire 69
Material fragmentation 65
Inflation issue 64
Component falling 61
Smoking 61
Component(s), overheating of 60
Overheating of device or device component 57
Material separation 57
Mechanical jam 57
Arcing at electrodes 53
Retraction problem 50
Therapeutic or diagnostic output failure 50
Intermittent continuity 47
Fracture 45
Device stops intermittently 39
Environmental Particulates 39
Leak 38
Not Applicable 36
Component missing 35
Improper flow or infusion 33
Difficult to remove 28
Loss of or failure to bond 28
Failure to Adhere or Bond 27
Foreign material present in device 27
Temperature issue 27
Material integrity issue 26
Failure to obtain samples 26
Improper or incorrect procedure or method 25
Loss of power 23
Electro-magnetic interference (EMI) 21
Failure to conduct 19
Output energy incorrect 18
System fails to activate 18
Material Protrusion 17
Device or device fragments location unknown 17
Charred 17
Image resolution poor 16
Malfunction 16
Defective component 16
Difficult or delayed activation 15
Device, removal of (non-implant) 15
Deployment issue 15
Noise, Audible 15
Naturally worn 14
Defective item 14
Noise 14
Loose or intermittent connection 14
Biofilm coating in device 13
Failure to shut off 13
Electronic property issue 12
Failure to separate 12
Failure to align 12
Dull 12
Balloon burst 12
No device output 12
Torn material 12
Failure to power-up 11
Hole in material 11
Device alarm system issue 11
Alarm, error of warning 11
Error or warning message, failure to produce 11
Physical resistance 11
Device packaging compromised 11
Failure to fire 10
Total Device Problems 12292

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 7 10 8 15 15 21 16 13 11 9 0
Class III 0 0 1 0 0 1 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 3M Company - Health Care Business II Dec-03-2016
2 Aesculap, Inc. II Dec-11-2013
3 Aesculap, Inc. II Feb-26-2013
4 Alcon Research, Ltd. II Dec-12-2014
5 Angiodynamics II Feb-24-2015
6 Angiodynamics, INC II Jul-10-2013
7 Angiodynamics, INC II Aug-24-2011
8 Applied Medical Resources Corp II Sep-15-2015
9 ArthroCare Corporation II Apr-05-2016
10 ArthroCare Corporation II Jan-08-2016
11 ArthroCare Corporation II Jul-18-2015
12 ArthroCare Corporation II Aug-30-2009
13 ArthroCare Corporation II Sep-19-2008
14 ArthroCare Medical Corporation II Jun-25-2015
15 ArthroCare Medical Corporation II Mar-26-2015
16 ArthroCare Medical Corporation II Dec-16-2014
17 Barrx Medical, Inc. II Jul-06-2011
18 Barrx Medical, Inc. II Oct-31-2008
19 Boston Scientific Corp II Sep-09-2009
20 Boston Scientific Corp II Sep-16-2008
21 Boston Scientific Corp II Sep-11-2008
22 Boston Scientific Corporation II Oct-18-2012
23 Boston Scientific Corporation III Mar-28-2012
24 Bovie Medical Corporation II Aug-25-2016
25 Cambridge Endoscopic Devices, Incorporated II Jul-06-2011
26 Centurion Medical Products II May-12-2010
27 ConMed Corporation II Dec-01-2015
28 ConMed Corporation II Nov-03-2015
29 ConMed Corporation II Jun-20-2014
30 ConMed Corporation II Jun-04-2014
31 ConMed Corporation II Nov-15-2013
32 ConMed Corporation II Feb-15-2013
33 ConMed Corporation II Jan-24-2013
34 ConMed Electrosurgery II May-29-2012
35 ConMed Electrosurgery II May-29-2012
36 ConMed Electrosurgery II Feb-17-2011
37 ConMed Electrosurgery II Aug-25-2010
38 ConMed Electrosurgery II May-10-2010
39 ConMed Electrosurgery II Nov-10-2009
40 ConMed Electrosurgery II Dec-11-2007
41 Conmed Corporation II Aug-19-2016
42 ConvaTec II Mar-16-2010
43 Covidien LLC II Sep-14-2012
44 Covidien LP II Jan-25-2011
45 Covidien, PLC II Jan-11-2012
46 Covidien, PLC II Aug-30-2011
47 Datascope Corporation II Aug-09-2007
48 DePuy Mitek, Inc., a Johnson & Johnson Co. II Dec-23-2015
49 DePuy Mitek, Inc., a Johnson & Johnson Co. II Oct-24-2012
50 DePuy Mitek, Inc., a Johnson & Johnson Co. II Aug-27-2010
51 Domain Surgical, Inc. II Dec-01-2016
52 EXP Pharmaceutical Services Corp II Jul-24-2015
53 Ellman International, Inc. II Dec-13-2016
54 Ellman International, Inc. II May-17-2012
55 Encision, Inc. II Jul-06-2012
56 Encision, Inc. II Aug-30-2011
57 Encision, Inc. II May-31-2011
58 Encision, Inc. II May-06-2010
59 Ethicon Endo-Surgery Inc II Jan-31-2013
60 Ethicon Endo-Surgery Inc II Mar-21-2012
61 Ethicon Endo-Surgery Inc II Feb-15-2011
62 Gyrus ACMI Corporation II Jan-14-2010
63 Gyrus ACMI Corporation II Nov-05-2008
64 Gyrus Acmi, Incorporated II Jun-11-2015
65 Gyrus Acmi, Incorporated II Sep-30-2010
66 Gyrus Medical, Inc II Oct-21-2014
67 Gyrus Medical, Inc II Aug-19-2013
68 Hemostatix Medical Technologies LLC II Sep-28-2010
69 Innovatech Medical Resources L.P. II Jan-11-2012
70 Instrumed International, Inc. II Sep-30-2014
71 Integra LifeSciences Corp. II May-31-2016
72 Kentucky Packaging Service LP II Nov-10-2009
73 Linvatec Corp. dba ConMed Linvatec II Sep-09-2009
74 Maquet Cardiovascular, LLC II Dec-06-2013
75 Maquet Cardiovascular, LLC II Sep-20-2011
76 Medtronic II Aug-17-2016
77 Medtronic Advanced Energy, LLC II Jan-31-2014
78 Medtronic Cardiac Surgery Technologies II Feb-02-2008
79 Medtronic Neuromodulation II Apr-02-2013
80 Megadyne Medical Products, Inc. II Mar-07-2014
81 Megadyne Medical Products, Inc. II Aug-27-2013
82 Megadyne Medical Products, Inc. III Dec-03-2009
83 Microline Surgical II May-20-2014
84 Microline Surgical, Inc. II Jul-02-2014
85 Microline Surgical, Inc. II Aug-29-2011
86 Nellcor Puritan Bennett Inc. (dba Covidien LP) II Aug-29-2012
87 Olympus America Inc. II Dec-05-2013
88 Olympus America Inc. II Jan-13-2012
89 PSC Industries Inc II Jul-12-2012
90 PSC Industries Inc II Jul-11-2012
91 Peak Surgical II Feb-02-2011
92 Plasma Surgical Inc. II Jun-11-2012
93 Progressive Medical Inc II May-22-2013
94 Rhytec Inc. II Feb-01-2007
95 Rita Medical Systems, Inc. II Apr-19-2007
96 Smith & Nephew, Inc. Endoscopy Division II Aug-03-2012
97 Smith & Nephew, Inc. Endoscopy Division II Jan-11-2012
98 Sorin Group USA, Inc. II Jan-14-2010
99 Sound Surgical Technologies, LLC II Jan-25-2011
100 Sound Surgical Technologies, LLC II Mar-13-2008
101 Starion Instruments II Aug-19-2010
102 Starion Instruments II Jul-09-2010
103 Starion Instruments II Jul-08-2010
104 Sterilmed Inc II Jan-13-2009
105 Stingray Surgical Products, LLC II Jul-13-2012
106 Stryker Endoscopy II Jun-24-2015
107 Stryker Endoscopy II May-02-2014
108 Stryker Endoscopy II Jul-09-2012
109 Stryker Endoscopy II Nov-21-2011
110 Stryker Endoscopy II Mar-17-2011
111 Stryker Endoscopy II Aug-09-2010
112 Stryker Endoscopy II Feb-09-2009
113 Stryker Endoscopy II Mar-05-2008
114 Stryker Endoscopy II Jan-17-2008
115 Stryker Sustainability Solutions, Inc. II Mar-13-2012
116 Surgical Instrument Service And Savings, Inc. II Jul-01-2013
117 Telefelx Medical II Sep-27-2010
118 Teleflex Medical II Jan-15-2014
119 The Anspach Effort, Inc. II Jun-25-2014
120 Unimed Surgical Products, Inc. II May-22-2013
121 Unimed Surgical Products, Inc. II Aug-28-2012
122 Unimed Surgical Products, Inc. II Oct-21-2009
123 Urologix, Inc. II Nov-08-2013
124 VNUS Medical Technologies Inc II Jan-24-2008
125 VNUS Medical Technologies Inc II Dec-15-2007
126 Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK II Nov-07-2007
127 Zinnanti Surgical Design LLC II Aug-14-2007

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