|
Device |
set, administration, intravascular |
Product Code | FPA |
Regulation Number |
880.5440
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
410 MEDICAL INNOVATION, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
410 MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ACACIA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ACTA MEDICAL LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AMSINO INTERNATIONAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
ANALYTICA PTY LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ANHUI KANGDA MEDICAL PRODUCTS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
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
|
6
|
B. BRAUN MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
B.BRAUN MEDICAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BAXTER HEALTHCARE CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
BAXTER HEALTHCARE CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
14
|
BAXTER HEALTHCARE CORPORATION - RENAL DIVISION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BECTON, DICKINSON AND COMPANY |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
BECTON, DICKINSON COMPANY |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BEIJING FERT TECHNOLOGY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BENLAN INC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BENLAN, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOMEDIX, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BQ PLUS MEDICAL CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BQ PLUS MEDICAL CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BUSSE HOSPITAL DISPOSABLES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
C.R BARD, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
C.R. BARD, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CAIR L.G.L |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CAIR LGL |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CAREFUSION |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
CAREFUSION 303 INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CAREFUSION, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CENTURION MEDICAL PRODUCTS CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
COOK VASCULAR INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DELTA MED SPA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DOUGLAS MEDICAL PRODUCTS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DRAGON HEART MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ELCAM MEDICAL A.C.A.L. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EMED TECHNOLOGIES CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
EPIC MEDICAL PTE LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EPIC MEDICAL PTE. LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EXELINT INTL. CO. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FRESENIUS KABI |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
GENESIS BPS LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HEALTH LINE INTERNATIONAL CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HOSPIRA, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HOSPIRA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
11
|
HOSPIRA,INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ICU MEDICAL INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ICU MEDICAL, INC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ICU MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
IMED TECHNOLOGY, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INFUSION INNOVATIONS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INNOVATIVE HEALTH SCIENCES, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
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
|
JIANGXI HONGDA MEDICAL EQUIPMENT GROUP LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JIANGYIN CAINA TECHNOLOGY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JIANGYIN CAINA TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KAWASUMI LABORATORIES AMERICA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KAWASUMI LABORATORIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
LILY MEDICAL CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MACLIN POWER INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MAGNOLIA MEDICAL TECHNOLOGIES INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDCAPTAIN LIFE SCIENCE CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MEDICAL COMPONENTS INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDLINE INDUSTRIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDSAFETY SOLUTIONS LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDTRONIC MINIMED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDX-SET LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MIGADA PLANT |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MPS ACACIA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MULTI MED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NEXUS MEDICAL LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NEXUS MEDICAL, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
7
|
NIPRO MEDICAL CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
NP MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NP MEDICAL INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NP MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PADI-LOCK, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PEROUSE MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
POLY MEDICURE LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PURACATH MEDICAL, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
Q CORE MEDICAL LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
Q FOR PLASTIC INDUSTRIES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
QUEST MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
REPRO-MED SYSTEMS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
REPRO-MED SYSTEMS, INC. DBA RMS MEDICAL PRODUCTS |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
RETRACTABLE TECHNOLOGIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ROCHE DIABETES CARE AG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ROCHE DIAGNOSTICS CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ROCHE DIAGNOSTICS GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RX DEVICES LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RYMED TECHNOLOGIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RYMED TECHNOLOGIES, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHAN DONG WEI GAO GROUP MEDICAL POLYMER PRODUCTS |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SHANGHAI KINDLY ENT. DEVELOPMENT GROUP CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHINVA ANDE HEALTHCARE APPARATUS CO.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SICHUAN PRIUS BIOTECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
SMITHS MEDICAL ASD, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SMITHS MEDICAL MD, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TERUMO EUROPE N.V. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
TERUMO MEDICAL PRODUCTS (HANGZHOU) CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TEVA MEDICAL LTD., MIGADA PLANT |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TOPSPINS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
U & U MEDICAL TECHNOLOGY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
UNOMEDICAL A/S |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
UNOMEDICAL A/S INFUSION DEVICES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
UNOMEDICAL DEVICES S.A DE C.V |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
US INFUSION DBA TRUECARE BIOMEDIX |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VELANO VASCULAR |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
VICTUS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WUHAN W.E.O SCIENCE & TECHNOLOGY DEVELOPMENT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
YANGZHOU WEI DE LI TRADE CO. LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
YPSOMED AG |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
YUKON MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
YUKON MEDICAL, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZYNO MEDICAL LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
|
Recalls |
Manufacturer |
Recall Class |
Date Posted |
1 |
Angiodynamics Inc. (Navilyst Medical Inc.) |
II |
Mar-29-2017 |
2 |
Arrow International Inc |
I |
Mar-30-2010 |
3 |
Arrow International Inc |
II |
Jun-24-2009 |
4 |
Asante Solutions, Inc. |
II |
Dec-27-2013 |
5 |
Avanos Medical, Inc. |
II |
Nov-08-2022 |
6 |
B Braun Medical Inc |
II |
May-23-2017 |
7 |
B. Braun Medical, Inc. |
I |
Dec-01-2023 |
8 |
B. Braun Medical, Inc. |
II |
Nov-03-2023 |
9 |
B. Braun Medical, Inc. |
II |
Oct-14-2022 |
10 |
B. Braun Medical, Inc. |
II |
Sep-24-2021 |
11 |
B. Braun Medical, Inc. |
II |
Jul-23-2021 |
12 |
B. Braun Medical, Inc. |
II |
Apr-29-2021 |
13 |
B. Braun Medical, Inc. |
II |
Feb-02-2020 |
14 |
B. Braun Medical, Inc. |
I |
Sep-23-2019 |
15 |
B. Braun Medical, Inc. |
II |
Jun-25-2018 |
16 |
B. Braun Medical, Inc. |
II |
Jul-09-2014 |
17 |
B. Braun Medical, Inc. |
II |
Feb-18-2014 |
18 |
B. Braun Medical, Inc. |
II |
Jan-26-2010 |
19 |
B. Braun Medical, Inc. |
II |
Jun-05-2009 |
20 |
BD SWITZERLAND SARL |
II |
May-13-2020 |
21 |
Bard Access Systems |
II |
Jan-10-2017 |
22 |
Bard Access Systems |
II |
Apr-30-2015 |
23 |
Bard Access Systems |
II |
Mar-13-2015 |
24 |
Bard Access Systems |
II |
Feb-26-2010 |
25 |
Baxter Healthcare Corp |
II |
Oct-16-2015 |
26 |
Baxter Healthcare Corp |
II |
Sep-09-2014 |
27 |
Baxter Healthcare Corp. |
II |
Aug-29-2016 |
28 |
Baxter Healthcare Corp. |
II |
Jan-07-2016 |
29 |
Baxter Healthcare Corp. |
II |
Oct-30-2013 |
30 |
Baxter Healthcare Corp. |
II |
Oct-29-2013 |
31 |
Baxter Healthcare Corp. |
II |
May-07-2013 |
32 |
Baxter Healthcare Corp. |
I |
Oct-09-2012 |
33 |
Baxter Healthcare Corp. |
II |
Jan-11-2012 |
34 |
Baxter Healthcare Corp. |
II |
Aug-03-2011 |
35 |
Baxter Healthcare Corp. |
II |
Jul-15-2011 |
36 |
Baxter Healthcare Corp. |
II |
Jun-29-2011 |
37 |
Baxter Healthcare Corp. |
II |
Dec-01-2010 |
38 |
Baxter Healthcare Corp. |
II |
Oct-27-2010 |
39 |
Baxter Healthcare Corp. |
II |
Oct-15-2010 |
40 |
Baxter Healthcare Corp. |
II |
Dec-09-2009 |
41 |
Baxter Healthcare Corporation |
II |
Mar-14-2024 |
42 |
Baxter Healthcare Corporation |
I |
Sep-14-2022 |
43 |
Baxter Healthcare Corporation |
II |
Feb-09-2021 |
44 |
Baxter Healthcare Corporation |
II |
Jan-09-2020 |
45 |
Bayer Medical Care, Inc. |
II |
Oct-11-2018 |
46 |
Becton Dickinson & Company |
II |
Nov-17-2023 |
47 |
Becton Dickinson & Company |
II |
Nov-04-2019 |
48 |
Becton Dickinson & Company |
II |
Oct-07-2019 |
49 |
Becton Dickinson & Company |
I |
Jul-11-2019 |
50 |
Becton Dickinson & Company |
I |
Jun-26-2019 |
51 |
Becton Dickinson & Company |
II |
Apr-10-2019 |
52 |
Becton Dickinson & Company |
II |
Nov-04-2018 |
53 |
Becton Dickinson & Company |
II |
May-01-2017 |
54 |
Becton Dickinson & Company |
II |
Mar-25-2015 |
55 |
Becton Dickinson Medical Systems |
I |
Feb-02-2010 |
56 |
Biomedix, Inc. |
II |
Oct-06-2014 |
57 |
C.R. Bard, Inc., Urological Division |
II |
Jun-29-2009 |
58 |
CAREFUSION |
II |
Sep-13-2022 |
59 |
CAREFUSION |
II |
Sep-13-2021 |
60 |
CAREFUSION |
II |
Jul-01-2021 |
61 |
CME America, LLC |
I |
Jul-15-2020 |
62 |
CME America, LLC |
II |
May-04-2020 |
63 |
CareFusion 303, Inc. |
II |
Nov-04-2018 |
64 |
CareFusion 303, Inc. |
II |
Jun-07-2018 |
65 |
CareFusion 303, Inc. |
II |
Aug-11-2017 |
66 |
CareFusion 303, Inc. |
II |
Apr-27-2017 |
67 |
CareFusion 303, Inc. |
II |
Feb-28-2017 |
68 |
CareFusion 303, Inc. |
II |
Feb-28-2017 |
69 |
CareFusion 303, Inc. |
II |
Mar-17-2016 |
70 |
CareFusion 303, Inc. |
II |
Dec-17-2015 |
71 |
CareFusion 303, Inc. |
II |
Nov-05-2015 |
72 |
CareFusion 303, Inc. |
II |
Feb-04-2015 |
73 |
CareFusion 303, Inc. |
II |
Jul-09-2014 |
74 |
CareFusion 303, Inc. |
II |
Apr-16-2014 |
75 |
CareFusion 303, Inc. |
II |
Feb-04-2014 |
76 |
CareFusion 303, Inc. |
II |
Feb-03-2014 |
77 |
CareFusion 303, Inc. |
II |
Dec-04-2013 |
78 |
CareFusion 303, Inc. |
II |
Dec-03-2013 |
79 |
CareFusion 303, Inc. |
II |
Sep-26-2013 |
80 |
CareFusion 303, Inc. |
II |
Sep-26-2013 |
81 |
CareFusion 303, Inc. |
II |
Sep-26-2013 |
82 |
Carefusion 303 Inc |
II |
Feb-15-2013 |
83 |
Carefusion 303, Inc. |
II |
Jun-29-2011 |
84 |
Centurion Medical Products Corporation |
II |
Feb-23-2016 |
85 |
Churchill Medical Systems, Inc. |
II |
Apr-21-2015 |
86 |
Churchill Medical Systems, Inc. |
II |
Jan-23-2014 |
87 |
Churchill Medical Systems, Inc. |
II |
Sep-18-2013 |
88 |
Churchill Medical Systems, Inc. |
II |
Mar-06-2013 |
89 |
Churchill Medical Systems, Inc. |
II |
Feb-16-2011 |
90 |
Churchill Medical Systems, Inc. |
II |
May-21-2010 |
91 |
Codan US Corporation |
II |
Jun-26-2020 |
92 |
Codan Us Corporation |
II |
Jul-10-2014 |
93 |
ConMed Corporation |
II |
Feb-28-2018 |
94 |
ConMed Corporation |
II |
Jan-11-2012 |
95 |
ConMed Corporation |
II |
Jan-11-2012 |
96 |
Exelint International Co. |
I |
Jan-22-2010 |
97 |
Global Healthcare Inc |
II |
Feb-03-2016 |
98 |
Hospira Inc. |
II |
Jun-29-2016 |
99 |
Hospira Inc. |
II |
Mar-06-2014 |
100 |
Hospira Inc. |
II |
Jul-18-2013 |
|
|
|
|