|
Device |
set, administration, intravascular |
Product Code | FPA |
Regulation Number |
880.5440
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
410 MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AMSINO INTERNATIONAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ANHUI TIANKANG MEDICAL TECHNOLOGY CO.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ASSET MEDIKAL TASARIM A.S. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ASSET MEDIKAL TASARIM AS. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
ASSET MEDIKAL TASARIM SAN TIC AS. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
B. BRAUN MEDICAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
B.BRAUN MEDICAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BAXTER HEALTHCARE CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
BECTON, DICKINSON AND COMPANY |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BQ PLUS MEDICAL CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BQ PLUS MEDICAL CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CAREFUSION |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
CAREFUSION, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EPIC MEDICAL PTE. LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FRESENIUS KABI |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
INNOVATIVE HEALTH SCIENCES, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INTERNATIONAL MEDICAL INDUSTRIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
IVENIX, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JIANGSU CAINA MEDICAL CO.,LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JIANGSU KANGBAO MEDICAL EQUIPMENT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JIANGSU SUYUN MEDICAL MATERIALS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KAWASUMI LABORATORIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MAGNOLIA MEDICAL TECHNOLOGIES INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDCAPTAIN LIFE SCIENCE CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDSAFETY SOLUTIONS LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NP MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NP MEDICAL INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
POLY MEDICURE LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PURACATH MEDICAL, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
QUEST MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
REPRO-MED SYSTEMS, INC. DBA RMS MEDICAL PRODUCTS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SICHUAN PRIUS BIOTECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
SMITHS MEDICAL ASD, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TERUMO MEDICAL PRODUCTS (HANGZHOU) CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
UNOMEDICAL A/S |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
VELANO VASCULAR |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
WUHAN W.E.O SCIENCE & TECHNOLOGY DEVELOPMENT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
YANGZHOU WEI DE LI TRADE CO. LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
MDR Year |
MDR Reports |
MDR Events |
2018 |
6570 |
6570 |
2019 |
11213 |
11213 |
2020 |
9553 |
9553 |
2021 |
10391 |
10392 |
2022 |
13392 |
13392 |
2023 |
7796 |
7796 |
|
Recalls |
Manufacturer |
Recall Class |
Date Posted |
1 |
Avanos Medical, Inc. |
II |
Nov-08-2022 |
2 |
B. Braun Medical, Inc. |
II |
Oct-14-2022 |
3 |
B. Braun Medical, Inc. |
II |
Sep-24-2021 |
4 |
B. Braun Medical, Inc. |
II |
Jul-23-2021 |
5 |
B. Braun Medical, Inc. |
II |
Apr-29-2021 |
6 |
B. Braun Medical, Inc. |
II |
Feb-02-2020 |
7 |
B. Braun Medical, Inc. |
I |
Sep-23-2019 |
8 |
B. Braun Medical, Inc. |
II |
Jun-25-2018 |
9 |
BD SWITZERLAND SARL |
II |
May-13-2020 |
10 |
Baxter Healthcare Corporation |
I |
Sep-14-2022 |
11 |
Baxter Healthcare Corporation |
II |
Feb-09-2021 |
12 |
Baxter Healthcare Corporation |
II |
Jan-09-2020 |
13 |
Bayer Medical Care, Inc. |
II |
Oct-11-2018 |
14 |
Becton Dickinson & Company |
II |
Nov-04-2019 |
15 |
Becton Dickinson & Company |
II |
Oct-07-2019 |
16 |
Becton Dickinson & Company |
I |
Jul-11-2019 |
17 |
Becton Dickinson & Company |
I |
Jun-26-2019 |
18 |
Becton Dickinson & Company |
II |
Apr-10-2019 |
19 |
Becton Dickinson & Company |
II |
Nov-04-2018 |
20 |
CAREFUSION |
II |
Sep-13-2022 |
21 |
CAREFUSION |
II |
Sep-13-2021 |
22 |
CAREFUSION |
II |
Jul-01-2021 |
23 |
CME America, LLC |
I |
Jul-15-2020 |
24 |
CME America, LLC |
II |
May-04-2020 |
25 |
CareFusion 303, Inc. |
II |
Nov-04-2018 |
26 |
CareFusion 303, Inc. |
II |
Jun-07-2018 |
27 |
Codan US Corporation |
II |
Jun-26-2020 |
28 |
ConMed Corporation |
II |
Feb-28-2018 |
29 |
ICU Medical, Inc. |
II |
Sep-09-2022 |
30 |
ICU Medical, Inc. |
II |
May-13-2021 |
31 |
ICU Medical, Inc. |
II |
Dec-23-2020 |
32 |
ICU Medical, Inc. |
II |
Oct-22-2020 |
33 |
ICU Medical, Inc. |
II |
May-06-2020 |
34 |
ICU Medical, Inc. |
I |
Apr-15-2019 |
35 |
Medtronic Inc. |
II |
Jul-05-2018 |
36 |
Molded Products Inc |
II |
Aug-22-2019 |
37 |
Quest Medical, Inc. |
II |
Feb-07-2023 |
38 |
Repro-Med Systems, Inc. |
II |
Oct-07-2019 |
39 |
Repro-Med Systems, Inc. |
II |
Jan-05-2018 |
40 |
Smiths Medical ASD Inc. |
I |
Jan-30-2023 |
41 |
Smiths Medical ASD Inc. |
II |
Oct-19-2021 |
42 |
Smiths Medical ASD Inc. |
II |
Oct-24-2019 |
43 |
Smiths Medical ASD Inc. |
II |
Oct-11-2018 |
44 |
Stradis Medical, LLC dba Stradis Healthcare |
II |
Dec-20-2021 |
45 |
Unomedical A/S |
II |
Sep-26-2022 |
46 |
Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. |
II |
Feb-21-2018 |
47 |
Vygon U.S.A. |
II |
Apr-09-2019 |
48 |
Zevex Incorporated (dba Moog Medical Medical Devices Group) |
II |
Feb-23-2018 |
49 |
Zyno Medical LLC |
II |
Jul-23-2019 |
|
|
|
|