|
Device |
system, thermal regulating |
Definition |
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf). |
Product Code | DWJ |
Regulation Number |
870.5900
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
3M COMPANY |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
AUGUSTINE BIOMEDICAL & DESIGN, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
AUGUSTINE TEMPERATURE MANAGEMENT |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
AUGUSTINE TEMPERATURE MANAGEMENT, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BCG MEDICAL, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BRAIN COOL AB |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BRAINCOOL AB |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CARE ESSENTIALS PTY LTD |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
CINCINNATI SUB-ZERO PRODUCTS, INC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CINCINNATI SUB-ZERO PRODUCTS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
COVIDIEN |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ENCOMPASS GROUP, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GALMAZ BIOTECH S.L. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GAYMAR INDUSTRIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GERATHERM MEDICAL AG |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
INSPIRATION HEALTHCARE LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
IOB MEDICAL INC |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
MEDIVANCE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
MEDLINE INDUSTRIES LP |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MOLNLYCKE HEALTH CARE US, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MTRE ADVANCED TECHNOLOGY LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
PINTLER MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SMITH MEDICAL ASD, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SMITHS MEDICAL ASD, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
STERIS CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
STIHLER ELECTRONIC GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
STRYKER MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
THE SURGICAL COMPANY INTERNATIONAL BV |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
THE SURGICAL COMPANY INTERNATIONAL BV (AS THE 37COMPANY) |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VITAHEAT MEDICAL, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WELKINS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
Recalls |
Manufacturer |
Recall Class |
Date Posted |
1 |
3M Company - Health Care Business |
II |
Feb-12-2018 |
2 |
Arizant Inc |
II |
Mar-01-2010 |
3 |
Bard Medical Division |
II |
Apr-27-2019 |
4 |
Bard Medical Division |
II |
Jul-24-2018 |
5 |
Belmont Instrument Corporation |
II |
Oct-31-2022 |
6 |
C.R. Bard, Inc. |
III |
Feb-12-2018 |
7 |
C.R. Bard, Inc. |
II |
Dec-20-2017 |
8 |
C.R. Bard, Inc. |
II |
Aug-16-2017 |
9 |
C.R. Bard, Inc. |
III |
Aug-05-2016 |
10 |
C.R. Bard, Inc. |
II |
May-06-2016 |
11 |
C.R. Bard, Inc. |
II |
Apr-14-2016 |
12 |
C.R. Bard, Inc. |
II |
Feb-05-2016 |
13 |
Care Essentials Pty., Ltd. |
II |
Mar-03-2020 |
14 |
Cincinnati Sub-Zero Products Inc |
II |
Jun-10-2014 |
15 |
Cincinnati Sub-Zero Products Inc |
II |
Dec-04-2013 |
16 |
Cincinnati Sub-Zero Products Inc |
II |
Sep-16-2013 |
17 |
Cincinnati Sub-Zero Products Inc |
II |
May-24-2012 |
18 |
Cincinnati Sub-Zero Products Inc |
II |
Feb-07-2012 |
19 |
Cincinnati Sub-Zero Products Inc |
II |
Sep-01-2011 |
20 |
Cincinnati Sub-Zero Products Inc |
II |
Jul-27-2011 |
21 |
Cincinnati Sub-Zero Products Inc |
II |
Jul-14-2011 |
22 |
Cincinnati Sub-Zero Products Inc |
II |
Jul-01-2011 |
23 |
Cincinnati Sub-Zero Products Inc |
II |
Mar-30-2011 |
24 |
Cincinnati Sub-Zero Products Inc |
II |
Feb-04-2010 |
25 |
Cincinnati Sub-Zero Products Inc |
II |
Oct-29-2009 |
26 |
Cincinnati Sub-Zero Products LLC, a Gentherm Company |
II |
Nov-18-2019 |
27 |
Cincinnati Sub-Zero Products LLC, a Gentherm Company |
II |
Sep-04-2019 |
28 |
Kimberly-Clark Corporation |
II |
Nov-29-2012 |
29 |
Kimberly-Clark Corporation |
II |
Aug-09-2012 |
30 |
Medivance Inc. |
II |
Jul-31-2024 |
31 |
Medivance Inc. |
II |
Mar-26-2024 |
32 |
Medtronic Perfusion Systems |
II |
Mar-06-2018 |
33 |
Pintler Medical LLC |
II |
Apr-12-2019 |
34 |
Smiths Medical ASD, Inc. |
II |
May-22-2014 |
35 |
Stryker Medical Division of Stryker Corporation |
II |
Oct-24-2018 |
36 |
Stryker Medical Division of Stryker Corporation |
II |
Jan-27-2018 |
37 |
Stryker Medical Division of Stryker Corporation |
II |
May-10-2017 |
38 |
Stryker Medical Division of Stryker Corporation |
II |
Feb-05-2014 |
39 |
Tec Com Gmbh |
II |
Nov-12-2019 |
|
|
|
|