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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 26
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 3163
No Known Device Problem 706
Device displays error message 580
Detachment of device component 513
Device operates differently than expected 409
Unknown (for use when the device problem is not known) 403
Other (for use when an appropriate device code cannot be identified) 358
Difficult to open or close 307
Peeled 305
Tip breakage 292
Device remains activated 265
Replace 239
Device inoperable 225
Energy output to patient tissue incorrect 215
Failure to deliver energy 213
No Information 210
Spark 201
Electrical issue 189
Detachment of device or device component 180
Self-activation or keying 160
Material deformation 153
Melted 152
Bent 148
Component(s), broken 146
Device Issue 130
Burn of device or device component 118
Sticking 110
Mechanical issue 109
Failure to cut 87
Output issue 87
No code available 84
Dislodged or dislocated 78
Burst 77
Crack 77
Fire 73
Use of Device Issue 73
Arcing 72
Material fragmentation 68
Inflation issue 64
Smoking 63
Component falling 61
Component(s), overheating of 60
Material separation 60
Arcing at electrodes 58
Mechanical jam 58
Overheating of device or device component 57
Retraction problem 50
Therapeutic or diagnostic output failure 50
Intermittent continuity 47
Fracture 46
Environmental Particulates 39
Component missing 39
Device stops intermittently 39
Leak 38
Not Applicable 37
Improper flow or infusion 33
Temperature issue 29
Difficult to remove 28
Loss of or failure to bond 28
Failure to Adhere or Bond 28
Foreign material present in device 27
Material integrity issue 26
Improper or incorrect procedure or method 26
Failure to obtain samples 26
Electro-magnetic interference (EMI) 25
Loss of power 23
Failure to conduct 19
Material Protrusion 19
System fails to activate 18
Output energy incorrect 18
Charred 17
Device or device fragments location unknown 17
Malfunction 16
Difficult or delayed activation 16
Defective component 16
Image resolution poor 16
Loose or intermittent connection 15
Device, removal of (non-implant) 15
Deployment issue 15
Noise, Audible 15
Naturally worn 14
Defective item 14
Noise 14
Failure to shut off 13
Biofilm coating in device 13
Device alarm system issue 13
Balloon burst 12
No device output 12
Fail-safe mechanism issue 12
Electronic property issue 12
Failure to separate 12
Failure to align 12
Dull 12
Torn material 12
Physical resistance 11
Device packaging compromised 11
Failure to power-up 11
Hole in material 11
Alarm, error of warning 11
Error or warning message, failure to produce 11
Total Device Problems 12615

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 1
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 Implant Systems LLC II Feb-16-2017
3 Aesculap, Inc. II Dec-11-2013
4 Aesculap, Inc. II Feb-26-2013
5 Alcon Research, Ltd. II Dec-12-2014
6 Angiodynamics II Feb-24-2015
7 Angiodynamics, INC II Jul-10-2013
8 Angiodynamics, INC II Aug-24-2011
9 Applied Medical Resources Corp II Sep-15-2015
10 ArthroCare Corporation II Apr-05-2016
11 ArthroCare Corporation II Jan-08-2016
12 ArthroCare Corporation II Jul-18-2015
13 ArthroCare Corporation II Aug-30-2009
14 ArthroCare Corporation II Sep-19-2008
15 ArthroCare Medical Corporation II Jun-25-2015
16 ArthroCare Medical Corporation II Mar-26-2015
17 ArthroCare Medical Corporation II Dec-16-2014
18 Barrx Medical, Inc. II Jul-06-2011
19 Barrx Medical, Inc. II Oct-31-2008
20 Boston Scientific Corp II Sep-09-2009
21 Boston Scientific Corp II Sep-16-2008
22 Boston Scientific Corp II Sep-11-2008
23 Boston Scientific Corporation II Oct-18-2012
24 Boston Scientific Corporation III Mar-28-2012
25 Bovie Medical Corporation II Aug-25-2016
26 Cambridge Endoscopic Devices, Incorporated II Jul-06-2011
27 Centurion Medical Products II May-12-2010
28 ConMed Corporation II Dec-01-2015
29 ConMed Corporation II Nov-03-2015
30 ConMed Corporation II Jun-20-2014
31 ConMed Corporation II Jun-04-2014
32 ConMed Corporation II Nov-15-2013
33 ConMed Corporation II Feb-15-2013
34 ConMed Corporation II Jan-24-2013
35 ConMed Electrosurgery II May-29-2012
36 ConMed Electrosurgery II May-29-2012
37 ConMed Electrosurgery II Feb-17-2011
38 ConMed Electrosurgery II Aug-25-2010
39 ConMed Electrosurgery II May-10-2010
40 ConMed Electrosurgery II Nov-10-2009
41 ConMed Electrosurgery II Dec-11-2007
42 Conmed Corporation II Aug-19-2016
43 ConvaTec II Mar-16-2010
44 Covidien LLC II Sep-14-2012
45 Covidien LP II Jan-25-2011
46 Covidien, PLC II Jan-11-2012
47 Covidien, PLC II Aug-30-2011
48 Datascope Corporation II Aug-09-2007
49 DePuy Mitek, Inc., a Johnson & Johnson Co. II Dec-23-2015
50 DePuy Mitek, Inc., a Johnson & Johnson Co. II Oct-24-2012
51 DePuy Mitek, Inc., a Johnson & Johnson Co. II Aug-27-2010
52 Domain Surgical, Inc. II Dec-01-2016
53 EXP Pharmaceutical Services Corp II Jul-24-2015
54 Ellman International, Inc. II Dec-13-2016
55 Ellman International, Inc. II May-17-2012
56 Encision, Inc. II Jul-06-2012
57 Encision, Inc. II Aug-30-2011
58 Encision, Inc. II May-31-2011
59 Encision, Inc. II May-06-2010
60 Ethicon Endo-Surgery Inc II Jan-31-2013
61 Ethicon Endo-Surgery Inc II Mar-21-2012
62 Ethicon Endo-Surgery Inc II Feb-15-2011
63 Gyrus ACMI Corporation II Jan-14-2010
64 Gyrus ACMI Corporation II Nov-05-2008
65 Gyrus Acmi, Incorporated II Jun-11-2015
66 Gyrus Acmi, Incorporated II Sep-30-2010
67 Gyrus Medical, Inc II Oct-21-2014
68 Gyrus Medical, Inc II Aug-19-2013
69 Hemostatix Medical Technologies LLC II Sep-28-2010
70 Innovatech Medical Resources L.P. II Jan-11-2012
71 Instrumed International, Inc. II Sep-30-2014
72 Integra LifeSciences Corp. II May-31-2016
73 Kentucky Packaging Service LP II Nov-10-2009
74 Linvatec Corp. dba ConMed Linvatec II Sep-09-2009
75 Maquet Cardiovascular, LLC II Dec-06-2013
76 Maquet Cardiovascular, LLC II Sep-20-2011
77 Medtronic II Aug-17-2016
78 Medtronic Advanced Energy, LLC II Jan-31-2014
79 Medtronic Cardiac Surgery Technologies II Feb-02-2008
80 Medtronic Neuromodulation II Apr-02-2013
81 Megadyne Medical Products, Inc. II Mar-07-2014
82 Megadyne Medical Products, Inc. II Aug-27-2013
83 Megadyne Medical Products, Inc. III Dec-03-2009
84 Microline Surgical II May-20-2014
85 Microline Surgical, Inc. II Jul-02-2014
86 Microline Surgical, Inc. II Aug-29-2011
87 Nellcor Puritan Bennett Inc. (dba Covidien LP) II Aug-29-2012
88 Olympus America Inc. II Dec-05-2013
89 Olympus America Inc. II Jan-13-2012
90 PSC Industries Inc II Jul-12-2012
91 PSC Industries Inc II Jul-11-2012
92 Peak Surgical II Feb-02-2011
93 Plasma Surgical Inc. II Jun-11-2012
94 Progressive Medical Inc II May-22-2013
95 Rhytec Inc. II Feb-01-2007
96 Rita Medical Systems, Inc. II Apr-19-2007
97 Smith & Nephew, Inc. Endoscopy Division II Aug-03-2012
98 Smith & Nephew, Inc. Endoscopy Division II Jan-11-2012
99 Sorin Group USA, Inc. II Jan-14-2010
100 Sound Surgical Technologies, LLC II Jan-25-2011
101 Sound Surgical Technologies, LLC II Mar-13-2008
102 Starion Instruments II Aug-19-2010
103 Starion Instruments II Jul-09-2010
104 Starion Instruments II Jul-08-2010
105 Sterilmed Inc II Jan-13-2009
106 Stingray Surgical Products, LLC II Jul-13-2012
107 Stryker Endoscopy II Jun-24-2015
108 Stryker Endoscopy II May-02-2014
109 Stryker Endoscopy II Jul-09-2012
110 Stryker Endoscopy II Nov-21-2011
111 Stryker Endoscopy II Mar-17-2011
112 Stryker Endoscopy II Aug-09-2010
113 Stryker Endoscopy II Feb-09-2009
114 Stryker Endoscopy II Mar-05-2008
115 Stryker Endoscopy II Jan-17-2008
116 Stryker Sustainability Solutions, Inc. II Mar-13-2012
117 Surgical Instrument Service And Savings, Inc. II Jul-01-2013
118 Telefelx Medical II Sep-27-2010
119 Teleflex Medical II Jan-15-2014
120 The Anspach Effort, Inc. II Jun-25-2014
121 Unimed Surgical Products, Inc. II May-22-2013
122 Unimed Surgical Products, Inc. II Aug-28-2012
123 Unimed Surgical Products, Inc. II Oct-21-2009
124 Urologix, Inc. II Nov-08-2013
125 VNUS Medical Technologies Inc II Jan-24-2008
126 VNUS Medical Technologies Inc II Dec-15-2007
127 Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK II Nov-07-2007
128 Zinnanti Surgical Design LLC II Aug-14-2007

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