|
Device |
automated external defibrillators (non-wearable) |
Definition |
This device is a non-wearable prescription use only aed. These are devices that include automated external defibrillation. Automated external defibrillators use external pad-type electrodes to sense, detect, classify and treat (with an electrical shock) ventricular fibrillation. These devices are intended to be used on suspected victims of sudden cardiac arrest. A person in cardiac arrest is unresponsive and is not breathing normally. The device can be sold with prescription only. |
Product Code | MKJ |
Regulation Number |
870.5310
|
Device Class |
3
|
Premarket Approvals (PMA) |
2019 |
2020 |
2021 |
2022 |
2023 |
2024 |
25
|
52
|
41
|
19
|
24
|
16
|
|
MDR Year |
MDR Reports |
MDR Events |
2019 |
16860 |
16860 |
2020 |
16197 |
16197 |
2021 |
16300 |
16300 |
2022 |
14867 |
14867 |
2023 |
13766 |
13766 |
2024 |
10424 |
10424 |
|
Recalls |
Manufacturer |
Recall Class |
Date Posted |
1 |
Cardiac Science Corporation |
II |
Jul-03-2019 |
2 |
Defibtech, LLC |
II |
Mar-30-2023 |
3 |
Defibtech, LLC |
II |
Jun-17-2020 |
4 |
HeartSine Technologies Ltd |
II |
May-14-2024 |
5 |
HeartSine Technologies Ltd |
II |
Feb-15-2024 |
6 |
HeartSine Technologies Ltd |
II |
Jul-13-2023 |
7 |
HeartSine Technologies Ltd |
II |
Mar-03-2023 |
8 |
Philips North America, LLC |
II |
Oct-23-2020 |
9 |
Philips North America, LLC |
II |
Aug-13-2020 |
10 |
Philips North America, LLC |
II |
May-28-2020 |
11 |
Philips North America, LLC |
II |
May-28-2020 |
12 |
Philips North America, LLC |
II |
May-27-2020 |
13 |
Philips North America, LLC |
II |
May-20-2020 |
14 |
Philips North America, LLC |
II |
May-20-2020 |
15 |
Philips North America, LLC |
II |
Mar-13-2020 |
16 |
Philips North America, LLC |
II |
Feb-21-2020 |
17 |
Philips North America, LLC |
II |
Dec-05-2019 |
18 |
Philips North America, LLC |
II |
Nov-19-2019 |
19 |
Philips North America, LLC |
II |
Sep-06-2019 |
20 |
Philips North America, LLC |
II |
Jul-05-2019 |
21 |
Philips North America LLC |
II |
Apr-06-2022 |
22 |
Philips North America LLC |
II |
Oct-08-2021 |
23 |
Philips North America LLC |
II |
Sep-03-2021 |
24 |
Philips North America LLC |
II |
Feb-19-2020 |
25 |
Philips North America LLC |
II |
Sep-20-2019 |
26 |
Physio-Control Inc |
I |
Feb-26-2019 |
27 |
Physio-Control, Inc. |
II |
Dec-15-2023 |
28 |
Physio-Control, Inc. |
II |
Nov-14-2023 |
29 |
Physio-Control, Inc. |
III |
Mar-10-2022 |
30 |
Physio-Control, Inc. |
II |
Mar-09-2021 |
31 |
Physio-Control, Inc. |
II |
Jun-11-2020 |
32 |
Physio-Control, Inc. |
II |
Apr-01-2020 |
33 |
Physio-Control, Inc. |
II |
Jan-16-2020 |
34 |
ZOLL Medical Corporation |
II |
Jul-03-2019 |
35 |
Zoll Medical Corporation |
II |
Jul-10-2024 |
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