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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
Definition Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Product CodeGEI
Regulation Number 878.4400
Device Class 2


Premarket Reviews
ManufacturerDecision
ADEOR MEDICAL AG
  SUBSTANTIALLY EQUIVALENT 1
AERIN MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1
AERIN MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 2
AESCULAP INC.
  SUBSTANTIALLY EQUIVALENT 2
AESCULAP, INC.
  SUBSTANTIALLY EQUIVALENT 1
AESTHETICS BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 1
AGENCY FOR MEDICAL INNOVATIONS GMBH
  SUBSTANTIALLY EQUIVALENT 1
AGNES MEDICAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
ALMA LASERS INC.
  SUBSTANTIALLY EQUIVALENT 1
APPLIED MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
APPLIED MEDICAL RESOURCES CORP.
  SUBSTANTIALLY EQUIVALENT 5
APPLIED MEDICAL RESOURCES CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
APYX MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
APYX MEDICAL CORPORATION (FORMERLY BOVIE MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
APYX MEDICAL CORPORATION(FORMERLY BOVIE MEDICAL CORPORATION)
  SUBSTANTIALLY EQUIVALENT 2
ARTHROCARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 6
AUCKLAND MEDICAL POLYMER(TIANJIN) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
AUGUSTINE TEMPERATURE MANAGEMENT LLC
  SUBSTANTIALLY EQUIVALENT 1
BAISHENG MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BIPAD SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
BOLDER SURGICAL, LLC
  SUBSTANTIALLY EQUIVALENT 3
BOLDER SURGICAL, LLC.
  SUBSTANTIALLY EQUIVALENT 1
BOVIE MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
BOVIE MEDICAL CORPORATION DBA APYX MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
BOWA-ELECTRONICS GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 2
BRERA MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1
BRONCUS MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
BTL
  SUBSTANTIALLY EQUIVALENT 3
BTL INDUSTRIES INC.
  SUBSTANTIALLY EQUIVALENT 3
BTL INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
CAMBRIDGE INTERVENTIONAL LLC
  SUBSTANTIALLY EQUIVALENT 1
CANDELA CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
CARTESSA AESTHETICS
  SUBSTANTIALLY EQUIVALENT 1
CATHAY MANFACTURING CORP.
  SUBSTANTIALLY EQUIVALENT 1
CHUNGWOO CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CNC TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
COMPEX, SPOL. S.R.O
  SUBSTANTIALLY EQUIVALENT 1
CONMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 5
COVIDIEN LLC
  SUBSTANTIALLY EQUIVALENT 3
COVIDIEN, LLC
  SUBSTANTIALLY EQUIVALENT 4
CUTERA INC.
  SUBSTANTIALLY EQUIVALENT 2
CYNOSURE LLC
  SUBSTANTIALLY EQUIVALENT 1
CYNOSURE, INC
  SUBSTANTIALLY EQUIVALENT 2
CYNOSURE, LLC
  SUBSTANTIALLY EQUIVALENT 1
DANNIK
  SUBSTANTIALLY EQUIVALENT 2
DANNIK LLC
  SUBSTANTIALLY EQUIVALENT 2
DEX SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
ELLUSA, LLC
  SUBSTANTIALLY EQUIVALENT 4
ENCISION INC.
  SUBSTANTIALLY EQUIVALENT 1
ENCISION INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
ENERGIST LIMITED
  SUBSTANTIALLY EQUIVALENT 1
ERBE ELEKTROMEDIZIN GMBH
  SUBSTANTIALLY EQUIVALENT 3
ETHICON ENDO-SURGERY
  SUBSTANTIALLY EQUIVALENT 1
ETHICON ENDO-SURGERY, LLC
  SUBSTANTIALLY EQUIVALENT 5
F CARE SYSTEMS USA LLC
  SUBSTANTIALLY EQUIVALENT 1
FAULHABER PINZETTEN OHG
  SUBSTANTIALLY EQUIVALENT 1
FHC, INC.
  SUBSTANTIALLY EQUIVALENT 1
FULWELL LLC
  SUBSTANTIALLY EQUIVALENT 2
GENICON, INC.
  SUBSTANTIALLY EQUIVALENT 1
GMV S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
GUENTER BISSINGER MEDIZINTECHNIK GMBH
  SUBSTANTIALLY EQUIVALENT 1
GUNTER BISSINGER MEDIZINTECHNIK GMBH
  SUBSTANTIALLY EQUIVALENT 1
GYRUS ACMI, INC.
  SUBSTANTIALLY EQUIVALENT 1
HEMOSTATIX MEDICAL TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
HIRONIC CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
HOOGLAND SPINE PRODUCTS, GMBH
  SUBSTANTIALLY EQUIVALENT 1
HS HOSPITAL SERVICE SPA
  SUBSTANTIALLY EQUIVALENT 1
HUNAN HANDLIKE MINIMALLY INVASIVE SURGERY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ILOODA CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
ILOODA CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
INMODE LTD.
  SUBSTANTIALLY EQUIVALENT 2
INMODE MD LTD.
  SUBSTANTIALLY EQUIVALENT 4
INNOBLATIVE DESIGNS, INC.
  SUBSTANTIALLY EQUIVALENT 1
INTEGRA LIFESCIENCES CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
INTEGRA MICROFRANCE
  SUBSTANTIALLY EQUIVALENT 1
INTELIS INSTRUMENTS LTD.
  SUBSTANTIALLY EQUIVALENT 1
INTUITIVE SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
INVUITY INC.
  SUBSTANTIALLY EQUIVALENT 1
ITALIAN ENGINEERING SRL
  SUBSTANTIALLY EQUIVALENT 1
JEISYS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
JEISYS MEDICAL INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
JEISYS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
KATALYST SURGICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
KLS MARTIN GMBH + CO. KG
  SUBSTANTIALLY EQUIVALENT 1
LED SPA
  SUBSTANTIALLY EQUIVALENT 1
LEXINGTON MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
LINA MEDICAL APS
  SUBSTANTIALLY EQUIVALENT 1
LIVSMED INC.
  SUBSTANTIALLY EQUIVALENT 5
LUMENDI, LLC
  SUBSTANTIALLY EQUIVALENT 2
LUTRONIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
MAQUET CARDIOVASCULAR, LLC.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTIRES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 4
MEDRANGE
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC ADVANCED ENERGY
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC NAVIGATION
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC SOFAMOR DANEK USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEGADYNE MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
MICRO-TECH (NANJING) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
MICROLINE SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
MODERN MEDICAL EQUIPMENT MANUFACTURING, LTD.
  SUBSTANTIALLY EQUIVALENT 4
NEAUVIA NORTH AMERICA, INC
  SUBSTANTIALLY EQUIVALENT 3
NEURENT MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
NEW DEANTRONICS TAIWAN LTD
  SUBSTANTIALLY EQUIVALENT 7
NEW DEANTRONICS TAIWAN, LTD.
  SUBSTANTIALLY EQUIVALENT 1
NICO CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
NINGBO SHUN YE MEDICAL COMPANY, LTD.
  SUBSTANTIALLY EQUIVALENT 1
NISSHA MEDICAL TECHNOLOGIES LTD
  SUBSTANTIALLY EQUIVALENT 1
NOVOXEL LTD.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS MEDICAL SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 3
OLYMPUS SURGICAL TECHNOLOGIES AMERICA
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS WINTER & IBE GMBH
  SUBSTANTIALLY EQUIVALENT 5
PAVMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
POLLOGEN LTD.
  SUBSTANTIALLY EQUIVALENT 2
PULSE BIOSCIENCES, INC.
  SUBSTANTIALLY EQUIVALENT 5
REBOUND THERAPEUTICS
  SUBSTANTIALLY EQUIVALENT 4
RF MEDICAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 3
RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ROHRER AESTHETICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
SEJONG MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENB CO LTD
  SUBSTANTIALLY EQUIVALENT 3
SHENB CO LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHINING WORLD HEALTH CARE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SOLTA MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
SONIQUENCE, LLC
  SUBSTANTIALLY EQUIVALENT 5
STARMED CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
STRYKER
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
STRYKER SUSTAINABILITY SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
SURGICAL DIRECT, INC.
  SUBSTANTIALLY EQUIVALENT 1
SURGNOVA HEALTHCARE TECHNOLOGIES (ZHEJIANG) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SURNIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SUTTER MEDIZINTECHNIK GMBH
  SUBSTANTIALLY EQUIVALENT 4
TELEFLEX MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
THERMIGEN, L.L.C
  SUBSTANTIALLY EQUIVALENT 1
TITAN MANUFACTURING, INC.
  SUBSTANTIALLY EQUIVALENT 1
TRIWORKS GROUP SRL
  SUBSTANTIALLY EQUIVALENT 2
UNITED STATES ENDOSCOPY GROUP, INC
  SUBSTANTIALLY EQUIVALENT 1
US ENDOSCOPY
  SUBSTANTIALLY EQUIVALENT 1
US MEDICAL INNOVATIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1
VENCLOSE, INC.
  SUBSTANTIALLY EQUIVALENT 1
VENUS CONCEPT USA INC.
  SUBSTANTIALLY EQUIVALENT 3
VIOL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
VIVEVE INC.
  SUBSTANTIALLY EQUIVALENT 1
VIVEVE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
VIVEVE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
VIVEVE, INC.
  SUBSTANTIALLY EQUIVALENT 1
WON TECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 6544 6544
2019 7065 7065
2020 6490 6490
2021 6352 6352
2022 6106 6106
2023 1132 1132

Device Problems MDRs with this Device Problem Events in those MDRs
Break 5768 5768
Adverse Event Without Identified Device or Use Problem 3642 3642
Energy Output Problem 2286 2286
Difficult to Open or Close 1687 1687
Detachment of Device or Device Component 1591 1591
Peeled/Delaminated 1226 1226
Output Problem 917 917
Electrical /Electronic Property Problem 897 897
Insufficient Information 746 746
Self-Activation or Keying 693 693
Material Separation 652 652
Delivered as Unsterile Product 647 647
Fire 599 599
Activation Problem 591 591
Retraction Problem 580 580
Failure to Deliver Energy 568 568
Sparking 565 565
Mechanical Problem 540 540
Material Twisted/Bent 527 527
Protective Measures Problem 508 508
Melted 500 500
Failure to Cut 410 410
Overheating of Device 391 391
Material Fragmentation 390 390
Use of Device Problem 371 371
Device Displays Incorrect Message 363 363
Mechanical Jam 344 344
Device Alarm System 343 343
Infusion or Flow Problem 338 338
Appropriate Term/Code Not Available 311 311
Smoking 308 308
Connection Problem 306 306
Defective Device 304 304
Material Integrity Problem 301 301
Suction Failure 289 289
Arcing 283 283
No Apparent Adverse Event 281 281
Device Remains Activated 269 269
Energy Output To Patient Tissue Incorrect 264 264
Detachment Of Device Component 246 246
Electrical Shorting 237 237
Temperature Problem 234 234
Intermittent Energy Output 200 200
Therapeutic or Diagnostic Output Failure 192 192
Loss of or Failure to Bond 190 190
Thermal Decomposition of Device 180 180
Fracture 174 174
Device Operates Differently Than Expected 171 171
Arcing of Electrodes 157 157
Failure to Power Up 155 155
Communication or Transmission Problem 152 152
Fitting Problem 150 150
Failure to Shut Off 140 140
Defective Component 139 139
Separation Problem 133 133
Pitted 132 132
Circuit Failure 130 130
Noise, Audible 130 130
Patient Device Interaction Problem 127 127
Continuous Firing 127 127
Material Deformation 125 125
Blocked Connection 125 125
Inaccurate Delivery 125 125
Flare or Flash 120 120
Failure to Fire 118 118
Image Display Error/Artifact 115 115
Activation, Positioning or Separation Problem 111 111
Degraded 111 111
No Flow 111 111
Physical Resistance/Sticking 110 110
No Device Output 108 108
Device Damaged Prior to Use 100 100
Flaked 97 97
Crack 97 97
Component Missing 97 97
Improper or Incorrect Procedure or Method 97 97
Power Problem 94 94
Difficult or Delayed Activation 92 92
Environmental Particulates 92 92
Suction Problem 86 86
Unintended Power Up 86 86
Intermittent Continuity 82 82
Device Fell 79 79
Loose or Intermittent Connection 79 79
Difficult to Remove 74 74
Device Dislodged or Dislocated 71 71
Material Split, Cut or Torn 71 71
Packaging Problem 69 69
Entrapment of Device 67 67
Improper Flow or Infusion 65 65
Intermittent Loss of Power 65 65
Excessive Heating 65 65
Corroded 62 62
Device Inoperable 61 61
Output below Specifications 60 60
Leak/Splash 59 59
Loss of Power 59 59
Display or Visual Feedback Problem 57 57
Contamination /Decontamination Problem 57 57
Failure to Align 54 54

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 10889 10889
No Consequences Or Impact To Patient 10335 10336
No Known Impact Or Consequence To Patient 3601 3601
No Patient Involvement 1642 1642
Burn(s) 1597 1598
Insufficient Information 1094 1094
Hemorrhage/Bleeding 808 808
No Information 688 688
No Code Available 534 534
Blood Loss 435 435
Partial thickness (Second Degree) Burn 420 420
Superficial (First Degree) Burn 351 351
Foreign Body In Patient 330 330
Injury 266 266
Burn, Thermal 257 257
Pain 220 220
Full thickness (Third Degree) Burn 217 217
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 200 200
Not Applicable 192 192
Hematoma 144 144
Unspecified Tissue Injury 139 139
Unspecified Infection 133 133
Tissue Damage 129 129
Device Embedded In Tissue or Plaque 120 120
Erythema 115 115
Patient Problem/Medical Problem 106 106
Bowel Perforation 98 98
Blister 91 91
Skin Discoloration 88 88
Electric Shock 84 84
Perforation 73 73
Scar Tissue 63 63
Thrombosis/Thrombus 62 62
Death 53 53
Fistula 53 53
Inflammation 51 51
Necrosis 49 49
Abscess 48 48
Post Operative Wound Infection 43 43
Stenosis 40 40
Seroma 40 40
Fever 39 39
Numbness 38 38
Pneumothorax 36 36
Bowel Burn 35 35
Nerve Damage 34 34
Swelling/ Edema 34 34
Bruise/Contusion 33 33
Thrombus 33 33
Laceration(s) 33 33
Burning Sensation 31 31
Shock 29 29
Scarring 27 27
Swelling 26 26
Pleural Effusion 26 26
Phlebitis 25 25
Wound Dehiscence 25 25
Skin Inflammation/ Irritation 25 25
Abdominal Pain 24 24
Thrombosis 23 23
Radiation Exposure, Unintended 23 23
Skin Tears 23 23
Discomfort 23 23
Skin Irritation 22 22
Cardiac Arrest 21 21
Low Blood Pressure/ Hypotension 21 21
Adhesion(s) 21 21
Failure to Anastomose 20 20
Unintended Radiation Exposure 20 20
Arrhythmia 20 20
Laceration(s) of Esophagus 20 20
Ulcer 19 19
Sepsis 18 18
Chest Pain 18 18
Dysphagia/ Odynophagia 16 16
Peritonitis 16 16
Anemia 16 16
Tachycardia 15 15
Ascites 15 15
Internal Organ Perforation 15 15
Pulmonary Embolism 15 15
Rash 15 15
Unspecified Gastrointestinal Problem 15 15
Pneumonia 15 15
Atrial Fibrillation 14 14
Urinary Tract Infection 14 14
Obstruction/Occlusion 14 14
Gastrointestinal Hemorrhage 14 14
Urinary Retention 13 13
Cancer 13 13
Neuropathy 13 13
Rupture 12 12
Edema 12 12
Epistaxis 12 12
Unspecified Hepatic or Biliary Problem 12 12
Abrasion 11 11
Deformity/ Disfigurement 11 11
Perforation of Esophagus 11 11
Ecchymosis 11 11
Dyspnea 10 10

Recalls
Manufacturer Recall Class Date Posted
1 Aesculap Implant Systems LLC II Sep-09-2019
2 Angiodynamics Inc. (Navilyst Medical Inc.) II Nov-15-2019
3 Aomori Olympus Co., Ltd. II Feb-05-2021
4 Applied Medical Resources Corp II Nov-21-2019
5 Beaver Visitec International, Inc. II Jun-23-2022
6 Beaver-Visitec International Inc. II May-10-2018
7 Beaver-Visitec International Inc. II Apr-27-2018
8 Bolder Surgical, LLC II Mar-08-2022
9 Boston Scientific Corporation II Dec-22-2020
10 Bovie Medical Corporation II Feb-26-2021
11 Bovie Medical Corporation II May-20-2020
12 Bovie Medical Corporation II Oct-19-2018
13 Bovie Medical Corporation II Mar-21-2018
14 Carefusion 2200 Inc II Dec-03-2022
15 ConMed Corporation II Dec-09-2022
16 CooperSurgical, Inc. II Jun-10-2021
17 CooperSurgical, Inc. III Sep-16-2019
18 Covidien II Apr-12-2021
19 Covidien Llc II Jan-13-2022
20 Covidien Llc II Feb-25-2020
21 Covidien, PLC II Mar-18-2019
22 Dannoritzer Medizintechnik GmbH & Co. KG III Oct-03-2018
23 DeRoyal Industries Inc II May-01-2018
24 Ethicon Endo-Surgery Inc II Jun-26-2019
25 Gyrus ACMI, Inc. II Apr-17-2019
26 Integra LifeSciences Corp. II Aug-07-2019
27 Intuitive Surgical, Inc. II May-31-2022
28 Maquet Cardiovascular, LLC II Jan-19-2023
29 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
30 Megadyne Medical Products, Inc. II Aug-13-2018
31 Microline Surgical, Inc. II Jun-01-2019
32 Microline Surgical, Inc. II May-08-2018
33 Microline Surgical, Inc. II Feb-02-2018
34 Nico Corp. II Jun-09-2021
35 Olsen Medical II May-25-2018
36 Olympus Corporation of the Americas II Sep-26-2022
37 Olympus Corporation of the Americas II Aug-27-2021
38 Solta Medical Inc II Apr-07-2020
39 Steris Corporation II Nov-16-2022
40 Stryker Corporation II Mar-17-2020
41 Stryker Instruments Div. of Stryker Corporation II Apr-28-2020
42 Stryker Instruments Div. of Stryker Corporation II Jan-28-2020
43 Sutter Medizintechnik GmbH II Jul-31-2020
44 Teleflex Medical II Jan-18-2019
45 Terumo Cardiovascular Systems Corporation II Oct-24-2018
46 Xodus Medical Inc II Oct-16-2019
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