|
Device |
needle, hypodermic, single lumen |
Product Code | FMI |
Regulation Number |
880.5570
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
ACTUATED MEDICAL, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ALTAVIZ, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
AMERICAN MEDICAL MANUFACTURING, INC./ ADVANCED MED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ANHUI TIANKANG MEDICAL TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ANHUI TIANKANG MEDICAL TECHNOLOGY CO.,LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INC.) |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ARTSANA S.P.A |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AUTOSAFE-REFLEX INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AZUR MEDICAL COMPANY INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
B. BRAUN MEDICAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
B. BRAUN MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
B. BRAUN MELSUNGEN AG |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BARD ACCESS SYSTEMS, INC(BAS)[WHOLLY-OWNED SUBSIDIARY OF BD] |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BECTON DICKINSON & CO. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
BECTON DICKINSON AND COMPANY |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BECTON DICKINSON AND COMPANY (BD) |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BECTON, DICKINSON AND COMPANY |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BECTON, DICKINSON AND CO. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BECTON, DICKINSON AND COMPANY |
|
SUBSTANTIALLY EQUIVALENT
|
9
|
BERPU MEDICAL TECHNOLOGY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BERPU MEDICAL TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BIOTEKNE SRL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CC BIOTECHNOLOGY CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CHIRANA T. INJECTA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
COOK INCORPORATED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CPL CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DIABETIC SUPPLY OF SUNCOAST, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ECLIPSE MEDCORP, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EINSTEIN WORKS LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EINSTEIN WORKS, L.L.C |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EINSTEIN WORKS, L.L.C. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EXELINT INTERNATIONAL CO. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FACET TECHNOLOGIES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FACET TECHNOLOGIES, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
FEEL TECH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GANGAN MEDICAL TECHNOLOGY JIANGSU CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GEMTIER MEDICAL (SHANGHAI) INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GREINER BIO-ONE NA INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GREINER BIO-ONE NA INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
GREINER BIO-ONE NORTH AMERICA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
GUANGZHOU IMPROVE MEDICAL INSTRUMENTS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HANTECH MEDICAL DEVICE CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
HTL STREFA SA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HTL-STREFA S.A |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HTL-STREFA S.A. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
INTERNATIONAL MEDSURG CONNECTION |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
JEESUNG MEDICAL CO LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JIAMEI-UN CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JIANGSU CAINA MEDICAL CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
JIANGSU CAINA TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JIANGSU SHENLI MEDICAL PRODUCTION CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
KAWASUMI LABORATORIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KOFU FACTORY OF TERUMO CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KUO TAI HOSPITAL MANAGEMENTS & CONSULTANT CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
M.V. S.R.L. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDBIO LLC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDEXEL CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDEXEL CO.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDIBIO USA LLC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDIGARD LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDPRO SAFETY PRODUCTS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MHC MEDICAL PRODUCTS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MHC MEDICAL PRODUCTS, LLC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MYCO MEDICAL SUPPLIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
NANOPASS TECHNOLOGIES LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NINGBO MEDSUN MEDICAL CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NIPRO MEDICAL CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
NORFOLK MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NOVO NORDISK INC. |
|
SUBSTANTIALLY EQUIVALENT
|
7
|
OCUJECT, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
OCUJET, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
OWEN MUMFORD LTD |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
P/L BIOMEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
PIKDARE S.P.A |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PIKDARE SPA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PIPER ACCESS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
POONGLIM PHARMATECH INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
PROMAMEDICAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PROMISEMED HANGZHOU MEDITECH CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
9
|
PYNG MEDICAL CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
RETRACTABLE TECHNOLOGIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SAM® MEDICAL PRODUCTS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SANDSTONE MEDICAL (SUZHOU) INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SCANDINAVIAN HEALTH LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHANDONG CAREMED MEDICAL PRODUCTS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHANDONG WEIGAO GROUP MEDICAL POLYMER CO.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHANGHAI CARELIFE INTERNATIONAL TRADING CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHANGHAI DOUBLE DOVE INDUSTRIAL CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHANGHAI KINDLY ENTERPRISE DEVELOPMENT GROUP CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SHINA CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHINA CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHINA MED CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SICHUAN PRIUS BIOTECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SIMPLE DIAGNOSTICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SMITHS MEDICAL ASD, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SOL-MILENNIUM MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SOL-MILLENNIUM MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SOL-MILLENNIUM MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
STARCAP MEDICAL LLC ( DBA PRISM MEDICAL & DESIGN) |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
STAT MEDICAL DEVICES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
STERILANCE MEDICAL (SUZHOU) INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SUNGSHIM MEDICARE CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TELEFLEX MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
TERUMO (PHILIPPINES) CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
TERUMO CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TERUMO EUROPE N.V. |
|
SUBSTANTIALLY EQUIVALENT
|
8
|
THINKMED MEDICAL TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TIANJIN HUAHONG TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
TIGER MEDICAL PRODUCTS LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TWOBIENS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
U&U MEDICAL TECHNOLOGY CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
U&U MEDICAL TECHNOLOGY CO.,LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
U-NEEDLE B.V. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ULTIMED INCORPORATED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ULTIMED, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VACUTEST KIMA SRL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VIDACARE CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
VIDACARE LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
W. L. MED CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WAISMED LTD |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
WAISMED LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
WCM WASTE & COMPLIANCE MANAGEMENT, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WEIHAI HONGYU MEDICAL DEVICES CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WENZHOU BEIPU SCIENCE & TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WENZHOU WUZHOU IMPORT & EXPORT CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WEPON MEDICAL TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
WEST PHARMACEUTICAL SERVICES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WUXI YUSHOU MEDICAL APPLICANCES CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
YIDOBIO INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
YPSOMED AG |
|
SUBSTANTIALLY EQUIVALENT
|
8
|
ZHEJIANG KANGKANG MEDICAL-DEVICES CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ZHEJIANG KINDLY MEDICAL DEVICE CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZHEJIANG KINDLY MEDICAL DEVICES CO. LTD |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
Recalls |
Manufacturer |
Recall Class |
Date Posted |
1 |
Apellis Pharmaceuticals, Inc. |
II |
Sep-29-2023 |
2 |
Arrow International Inc |
II |
May-30-2018 |
3 |
Arrow International Inc |
II |
Feb-13-2018 |
4 |
B. Braun Medical, Inc. |
II |
Feb-09-2018 |
5 |
Bard Access Systems, Inc. |
I |
Jul-22-2022 |
6 |
Bard Peripheral Vascular Inc |
II |
Oct-01-2021 |
7 |
Becton Dickinson & Company |
II |
Dec-15-2020 |
8 |
Becton Dickinson & Company |
II |
Nov-27-2020 |
9 |
Becton Dickinson & Company |
II |
Aug-27-2020 |
10 |
Becton Dickinson & Company |
II |
Oct-31-2019 |
11 |
Becton Dickinson & Company |
II |
Oct-24-2019 |
12 |
Becton Dickinson & Company |
II |
Jul-22-2019 |
13 |
Becton Dickinson & Company |
II |
Oct-11-2018 |
14 |
Becton Dickinson & Company |
II |
Dec-07-2017 |
15 |
Becton Dickinson & Company |
II |
Sep-11-2017 |
16 |
Becton Dickinson & Company |
II |
Jul-19-2017 |
17 |
Becton Dickinson & Company |
II |
Feb-13-2012 |
18 |
Becton Dickinson & Company |
II |
May-13-2011 |
19 |
Becton Dickinson & Company |
II |
Dec-27-2010 |
20 |
C.A. Greiner & Sohne Gesellschaftmbh |
II |
Aug-28-2020 |
21 |
Cardinal Health 200, LLC |
II |
Mar-15-2021 |
22 |
Cardinal Health 200, LLC |
II |
Nov-05-2020 |
23 |
Cardinal Health 200, LLC |
II |
Mar-09-2020 |
24 |
Cardinal Health 200, LLC |
II |
Jul-23-2019 |
25 |
Cardinal Health Inc. |
II |
Jun-23-2021 |
26 |
Centurion Medical Products |
I |
Mar-15-2010 |
27 |
Centurion Medical Products Corporation |
II |
Jan-04-2018 |
28 |
Churchill Medical Systems, Inc. |
II |
May-01-2012 |
29 |
Exelint International Co. |
I |
Jan-22-2010 |
30 |
Global Healthcare Inc |
II |
Sep-22-2016 |
31 |
Greiner Bio-One North America, Inc. |
II |
Feb-15-2013 |
32 |
Greiner Bio-One North America, Inc. |
II |
Jul-03-2012 |
33 |
Greiner Bio-One North America, Inc. |
II |
Nov-09-2011 |
34 |
Greiner Bio-One North America, Inc. |
II |
Aug-08-2011 |
35 |
Guangzhou Improve Medical Instruments Co., Ltd. |
II |
Apr-24-2019 |
36 |
Guangzhou Improve Medical Instruments Co., Ltd. |
II |
Aug-12-2018 |
37 |
Guangzhou Improve Medical Instruments Co., Ltd. |
II |
Jul-26-2018 |
38 |
International Medsurg Connection, Inc. |
II |
Aug-04-2017 |
39 |
MHC Medical Products LLC |
II |
May-09-2018 |
40 |
Medical Device Technologies, Inc. |
II |
Jul-13-2010 |
41 |
Merz Aesthetics, Inc. |
III |
Jun-26-2015 |
42 |
Multi-Med, Inc. |
I |
Sep-29-2010 |
43 |
Multi-Med, Inc. |
I |
Jul-02-2010 |
44 |
Myco Medical Supplies Inc |
II |
Dec-17-2015 |
45 |
Owen Mumford USA, Inc. |
II |
Jul-15-2021 |
46 |
Owen Mumford USA, Inc. |
II |
Jan-17-2018 |
47 |
Pyng Medical Corporation |
II |
Jun-28-2011 |
48 |
Retractable Technologies, Inc. |
II |
Mar-14-2024 |
49 |
Smiths Medical ASD Inc. |
II |
Jun-04-2019 |
50 |
Smiths Medical ASD Inc. |
II |
Jul-03-2017 |
51 |
Smiths Medical ASD, Inc. |
II |
Dec-30-2014 |
52 |
Stat Medical Devices, Inc. |
II |
Jul-24-2009 |
53 |
Teleflex Medical |
II |
Dec-16-2019 |
54 |
Teleflex Medical |
III |
Apr-04-2017 |
55 |
Terumo Medical Corporation |
II |
Jul-22-2019 |
56 |
Terumo Medical Corporation |
II |
Jul-13-2011 |
57 |
Vidacare Corporation |
II |
Jun-15-2015 |
58 |
Vidacare Corporation |
II |
Sep-22-2014 |
59 |
Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. |
II |
Feb-21-2018 |
60 |
Waismed Ltd |
II |
Aug-27-2016 |
61 |
Zhejiang Kindly Medical Devices Co., Ltd. |
II |
Nov-05-2021 |
|
|
|
|