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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 10
ARAGON SURGICAL INC.
  SUBSTANTIALLY EQUIVALENT 4
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 1
ARTHROCARE CORP.
  SUBSTANTIALLY EQUIVALENT 73
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 14
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 24
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 28
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 2601
Device displays error message 530
No Known Device Problem 495
Detachment of device component 431
Unknown (for use when the device problem is not known) 403
Other (for use when an appropriate device code cannot be identified) 353
Device operates differently than expected 349
Tip breakage 292
Peeled 249
Replace 239
Device inoperable 223
Failure to deliver energy 209
Device remains activated 205
Electrical issue 178
Difficult to open or close 174
No Information 174
Detachment of device or device component 159
Component(s), broken 146
Bent 143
Spark 129
Device Issue 128
Melted 124
Burn of device or device component 107
Material deformation 104
Mechanical issue 102
Self-activation or keying 97
No code available 80
Energy output to patient tissue incorrect 77
Burst 77
Dislodged or dislocated 74
Sticking 74
Crack 72
Failure to cut 69
Use of Device Issue 64
Inflation issue 64
Arcing 61
Material fragmentation 60
Component(s), overheating of 60
Component falling 59
Smoking 55
Overheating of device or device component 54
Fire 51
Material separation 48
Retraction problem 48
Intermittent continuity 47
Mechanical jam 47
Output issue 43
Therapeutic or diagnostic output failure 42
Fracture 42
Leak 38
Environmental Particulates 38
Device stops intermittently 38
Arcing at electrodes 36
Component missing 32
Improper flow or infusion 32
Not Applicable 31
Loss of or failure to bond 28
Failure to Adhere or Bond 25
Difficult to remove 25
Temperature issue 25
Improper or incorrect procedure or method 25
Foreign material present in device 24
Loss of power 23
Material integrity issue 22
System fails to activate 18
Charred 17
Failure to conduct 17
Output energy incorrect 16
Image resolution poor 16
Device or device fragments location unknown 16
Malfunction 16
Device, removal of (non-implant) 15
Noise, Audible 15
Difficult or delayed activation 14
Noise 14
Naturally worn 14
Deployment issue 13
Defective item 13
Loose or intermittent connection 13
Biofilm coating in device 13
Balloon burst 12
Failure to align 12
Failure to separate 12
Defective component 12
Torn material 12
Device packaging compromised 11
Dull 11
Physical resistance 11
Alarm, error of warning 11
Error or warning message, failure to produce 11
Failure to power-up 11
No device output 11
Failure to shut off 10
Electronic property issue 10
Failure to fire 9
Tears, rips, holes in device, device material 8
Material Protrusion 8
Device, or device fragments remain in patient 8
No display or display failure 8
Degraded 8
Total Device Problems 10600

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 7 10 8 15 15 21 16 13 11 5
Class III 0 0 1 0 0 1 0 0 0 0

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

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