1
00763000118280
CIT200
MAPPING SYSTEM CIT200 US
N/A
MEDTRONIC, INC.
2
00763000045456
CITVST0004XL
SENSOR ARRAY VEST CITVST0004XL US
CardioInsight™
MEDTRONIC, INC.
3
00763000045449
CITVST0003L
SENSOR ARRAY VEST CITVST0003L US
CardioInsight™
MEDTRONIC, INC.
4
00763000045432
CITVST0002M
SENSOR ARRAY VEST CITVST0002M US
CardioInsight™
MEDTRONIC, INC.
5
00763000045425
CITVST0001S
SENSOR ARRAY VEST CITVST0001S US
CardioInsight™
MEDTRONIC, INC.
6
00732094315318
901012
11095-002-70
HSCRIBE TO PYRAMIS INTERFACE
Welch Allyn, Inc.
WELCH ALLYN, INC.
7
00732094272338
901152
11094-001-50
SFTW PYRAMIS IE9 10 UPGRADE V6.2 6.5
Welch Allyn, Inc.
WELCH ALLYN, INC.
8
00732094261332
901152
UPGHC-B-SW-A
UPGRADE KIT FOR HEARTCENTRIX
Welch Allyn, Inc.
WELCH ALLYN, INC.
9
00690103208573
HEMFSM10
HEMFSM10
HEMOSPHERE FORESIGHT MODULE
HEMOSPHERE FORESIGHT MODULE
EDWARDS LIFESCIENCES LLC
10
00690103202762
HEMCSM10
HEMCSM10
CLEARSIGHT MODULE
HemoSphere
EDWARDS LIFESCIENCES LLC
11
00690103200355
HEMTOM10
HEMTOM10
HemoSphere Tissue Oximetry Module
HemoSphere Tissue Oximetry Module
EDWARDS LIFESCIENCES LLC
12
00690103199338
HEMDPT1000
HEMDPT1000
DPT OUT CABLE
HEMOSPHERE
EDWARDS LIFESCIENCES LLC
13
00690103199321
HEMPSC100
HEMPSC100
Pressure Cable
HEMOSPHERE
EDWARDS LIFESCIENCES LLC
14
00690103197105
HEMRLSTD1000
HEMRLSTD1000
HemoSphere Roll Stand
HemoSphere
EDWARDS LIFESCIENCES LLC
15
00690103197006
HEM1
HEM1
HemoSphere Advanced Monitor
HemoSphere
EDWARDS LIFESCIENCES LLC
16
00690103196993
HEMSGM10
HEMSGM10
HemoSphere Swan-Ganz Module
HemoSphere
EDWARDS LIFESCIENCES LLC
17
00690103196986
HEMOXSC100
HEMOXSC100
HemoSphere Oximetry Cable
HemoSphere
EDWARDS LIFESCIENCES LLC
18
00643169723689
CITVST0004XL
SENSOR ARRAY VEST CITVST0004XL US
CardioInsight™
MEDTRONIC, INC.
19
00643169723672
CITVST0003L
SENSOR ARRAY VEST CITVST0003L US
CardioInsight™
MEDTRONIC, INC.
20
00643169723665
CITVST0002M
SENSOR ARRAY VEST CITVST0002M US
CardioInsight™
MEDTRONIC, INC.
21
00643169723658
CITVST0001S
SENSOR ARRAY VEST CITVST0001S US
CardioInsight™
MEDTRONIC, INC.
22
00643169723603
CIT200
MAPPING SYSTEM CIT200 CIT US
CardioInsight™
MEDTRONIC, INC.
23
00643169006874
9670590
ELECTRODE 9670590 5BX LOCALISA
LOCALISA®
MEDTRONIC, INC.
24
00195278516015
AltiX
5896597
Upgrade Kit MLCL V8.0
MLCL Upgrade
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
25
00195278507525
AltiX
5889605
Software Medical Device GE Client Software V8.0
MLCL Client Software
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
26
00195278507051
AltiX
2300000-005
Computer ComboLab Acquisition v8.0
ComboLab
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
27
00195278507044
AltiX
2300000-004
Computer CardioLab Acquisition v8.0
CardioLab
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
28
00195278288639
MBZ323
2087075-300
CARESCAPE ONE MBZ323 ATO MODEL
CARESCAPE ONE
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
29
00191506017224
H749009881CD0
Guidance System
AVVIGO™ Guidance System II
BOSTON SCIENTIFIC CORPORATION
30
00191506017187
H749009765R0
Guidance System
AVVIGO™ Guidance System II
BOSTON SCIENTIFIC CORPORATION
31
00191506015206
H749009881IZ0
Guidance System
AVVIGO™ Guidance System II
BOSTON SCIENTIFIC CORPORATION
32
00191506015190
H749009881IR0
Guidance System
AVVIGO™ Guidance System II
BOSTON SCIENTIFIC CORPORATION
33
00191506015183
H749009881I0
Guidance System
AVVIGO™ Guidance System II
BOSTON SCIENTIFIC CORPORATION
34
00191506015176
H749009881CZ0
Guidance System
AVVIGO™ Guidance System II
BOSTON SCIENTIFIC CORPORATION
35
00191506015169
H749009881CR0
Guidance System
AVVIGO™ Guidance System II
BOSTON SCIENTIFIC CORPORATION
36
00191506015152
H749009881C0
Guidance System
AVVIGO™ Guidance System II
BOSTON SCIENTIFIC CORPORATION
37
00191506015084
H7490097650
Guidance System
AVVIGO™ Guidance System II
BOSTON SCIENTIFIC CORPORATION
38
00191506000813
M004RAPATCH20
M004RAPATCH20
Location Reference Patch Kit
Rhythmia HDx™ Mapping System
BOSTON SCIENTIFIC CORPORATION
39
B972CCZ12050482050
4
CCZ1205048205
CER-S is stand-alone software medical device, providing advanced solutions for i
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CER-S is stand-alone software medical device, providing advanced solutions for importing, analyzing, editing, reviewing and generating clinical reports related to digital continuous ECG recordings (Holters). CER-S does not carry out an automated interpretation of the ECG data.
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CER-S
CARDIO CALM SRL
40
B972CCZ12050482030
4
CER-S is stand-alone software medical device, providing advanced solutions for i
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CER-S is stand-alone software medical device, providing advanced solutions for importing, analyzing, editing, reviewing and generating clinical reports related to digital continuous ECG recordings (Holters). CER-S does not carry out an automated interpretation of the ECG data.
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CER-S
CARDIO CALM SRL
41
B546VENDYS1
JK-001V
VENDYS II
ENDOTHELIX, INC.
42
B320VH120
VH12
Premier Heart MCG 12 Lead capture hardware.
Premier Heart MCG Model VH12
PREMIER HEART, LLC
43
B320MCGC0
MCGC
Premier Heart MCG Analysis Cluster software, including: - MCG Clinical Client (
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Premier Heart MCG Analysis Cluster software, including: - MCG Clinical Client (reference implementation and API) - MCG Webapps/Report Generator - MCG Clinical Database - MCG Analysis Engine
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Premier Heart MCG Analysis Software
PREMIER HEART, LLC
44
B320CF190
CF19
CF19
Premier Heart MCG Model CF19
Premier Heart MCG
PREMIER HEART, LLC
45
B273CEA0
2.1.xx
Cardiologs ECG analysis platform
Cardiologs Platform
CARDIOLOGS TECHNOLOGIES
46
80010939050027
14.0
McKesson Cardiology Hemo
MCKESSON TECHNOLOGIES INC.
47
80010939050010
13.2.1
McKesson Cardiology Hemo
MCKESSON TECHNOLOGIES INC.
48
80010939040028
14.0
McKesson Cardiology ECG Management
MCKESSON TECHNOLOGIES INC.
49
80010939040011
13.2.1
McKesson Cardiology ECG Management
MCKESSON TECHNOLOGIES INC.
50
20857553006072
M300-5
M300-5
Stealth System Wearable Sensor (M300).
Stealth System S300
CARDIAC INSIGHT, INC.