|
Device |
computer, diagnostic, programmable |
Product Code | DQK |
Regulation Number |
870.1425
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
ABBOTT |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
ABBOTT MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
7
|
ABLACON, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ACUTUS MEDICAL INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ACUTUS MEDICAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ACUTUS MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
9
|
ALIVECOR, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
BIOFOURMIS SINGAPORE PTE. LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOSENSE WEBSTER, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
9
|
BIOSIG TECHNOLOGIES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BOSTON SCIENTIFIC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BOSTON SCIENTIFIC CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
CARDIOCALM SRL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CARDIONXT, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CATH VISION APS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CATHETER PRECISION, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CATHVISION APS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CENTERLINE BIOMEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CORDIANA MEDICAL INFORMATICS AG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
COROVENTIS RESEARCH AB |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EDWARDS LFESCIENCES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EDWARDS LIFECIENCES, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EDWARDS LIFESCIENCES LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EDWARDS LIFESCIENCES, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
8
|
EDWARDS LIFESIENCES, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EPIPHANY HEALTHCARE, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GE HEALTHCARE INFORMATION TECHNOLOGIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
IMPLICITY, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
IRHYTHM TECHNOLOGIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
ITAMAR MEDICAL, LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDICALGORITHMICS S.A. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDTRONIC, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PHILIPS MEDICAL SYSTEM NEDERLAND B.V. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
PHILIPS MEDICAL SYSTEMS NEDERLAND, B.V. (PMSN) |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
QUIPU S.R.L |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RHYTHM AL, LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SCHWARZER CARDIOTEK GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN CAREWELL ELECTRONICS., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SIEMENS MEDICAL SOLUTIONS USA INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SMART SOLUTIONS TECHNOLOGIES SL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPACELABS HEALTHCARE LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ST. JUDE MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ST. JUDE MEDICAL (NOW ABBOTT MEDICAL) |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VEKTOR MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VOLTA MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
|
Recalls |
Manufacturer |
Recall Class |
Date Posted |
1 |
Abbott Laboratories Inc. (St Jude Medical) |
II |
Jun-14-2021 |
2 |
Biosense Webster (israel), Ltd. |
II |
Aug-24-2020 |
3 |
Boston Scientific Corporation |
II |
Apr-27-2020 |
4 |
CHANGE HEALTHCARE CANADA COMPANY |
II |
Apr-08-2020 |
5 |
CardioTek BV |
II |
Jun-23-2022 |
6 |
Change Healthcare Israel Ltd. |
II |
May-24-2019 |
7 |
Edwards Lifesciences, LLC |
II |
May-08-2020 |
8 |
Edwards Lifesciences, LLC |
II |
Jan-16-2018 |
9 |
GE Healthcare Finland Oy |
II |
Oct-10-2018 |
10 |
GE Healthcare Finland Oy |
II |
Jul-02-2018 |
11 |
GE Healthcare, LLC |
II |
Apr-13-2022 |
12 |
GE Healthcare, LLC |
II |
Jun-22-2021 |
13 |
GE Healthcare, LLC |
II |
Oct-31-2019 |
14 |
GE Healthcare, LLC |
II |
Jul-23-2019 |
15 |
GE Medical Systems Information Technologies Inc |
II |
Sep-19-2023 |
16 |
GE Medical Systems Information Technologies, Inc. |
II |
Jan-25-2018 |
17 |
Hitachi Healthcare Americas Corp Informatics Division |
II |
Sep-06-2018 |
18 |
Invivo Corporation |
II |
Nov-14-2018 |
19 |
McKesson Israel Ltd. |
II |
Aug-31-2018 |
20 |
Merge Healthcare, Inc. |
II |
Aug-28-2021 |
21 |
Merge Healthcare, Inc. |
II |
Jan-14-2018 |
22 |
Philips Electronics North America Corporation |
II |
Dec-14-2018 |
23 |
Siemens Medical Solutions USA, Inc |
II |
Jan-01-2023 |
24 |
Siemens Medical Solutions USA, Inc |
III |
Aug-18-2022 |
25 |
Siemens Medical Solutions USA, Inc |
II |
Jul-20-2022 |
26 |
Siemens Medical Solutions USA, Inc |
II |
Jun-06-2022 |
27 |
Siemens Medical Solutions USA, Inc |
II |
Jan-14-2022 |
28 |
Siemens Medical Solutions USA, Inc |
II |
Apr-19-2021 |
29 |
Siemens Medical Solutions USA, Inc |
II |
Mar-04-2021 |
30 |
Siemens Medical Solutions USA, Inc |
II |
Aug-28-2020 |
31 |
Siemens Medical Solutions USA, Inc |
II |
Feb-23-2019 |
32 |
Spacelabs Healthcare, Inc. |
II |
Jul-22-2019 |
33 |
Spacelabs Healthcare, Ltd. |
II |
Dec-10-2020 |
|
|
|
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