|
Device |
tubes, gastrointestinal (and accessories) |
Product Code | KNT |
Regulation Number |
876.5980
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
ABBOTT LABORATORIES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ABBVIE INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
|
SUBSTANTIALLY EQUIVALENT - KIT
|
2
|
ACTA MEDICAL L.L.C. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ACTUATED MEDICAL, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ACTUATED MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
ALAN REID |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
APPLIED MEDICAL TECHNOLOGY INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
APPLIED MEDICAL TECHNOLOGY, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
|
SUBSTANTIALLY EQUIVALENT - KIT
|
4
|
ART HEALTHCARE LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ASPIRE BARIATRICS, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ASPIRE BARIATRICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AVANOS MEDICAL INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AVANOS MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BD MEDICAL SURGICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BENLAN, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIONIX DEVELOPMENT CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BOEHRINGER LABORATORIES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BOEHRINGER LABORATORIES LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BOEHRINGER LABORATORIES, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BOSTON SCIENTIFIC CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
C.R. BARD INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
C.R. BARD, INC. |
|
SUBSTANTIALLY EQUIVALENT - KIT
|
2
|
CM TECHNOLOGIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CODAN US CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
COLOPLAST A/S |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
CONSURE MEDICAL PVT LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CONVATEC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CONVATEC INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CONVATEC LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CONVATEC LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
COOK INCORPORATED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
COOK INCORPORATED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
SUBSTANTIALLY EQUIVALENT - KIT
|
2
|
CORPAK MEDSYSTEMS |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
CORPAK MEDSYSTEMS, INC. A DIVISION OF HAYLARD HEALTH |
|
SUBSTANTIALLY EQUIVALENT - KIT
|
1
|
COVIDIEN |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
COVIDIEN (DBA MEDTRONIC) |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
COVIDIEN LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
COVIDIEN LP, FORMERLY REGISTERED AS KENDALL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CREATIVE BALLOONS GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CROSPON, LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DEGANIA SILICONE LTD |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
DEGANIA SILICONE LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DEGANIA SILICONE, LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
SUBSTANTIALLY EQUIVALENT - KIT
|
2
|
DENTSPLY SIRONA |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
DYNAREX CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ENDOLUMIK |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ENDOLUMIK INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ENTRACARE, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ENVIZION MEDICAL LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
FOOTPRINT MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FOOTPRINT MEDICAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GENERICA MEDICAL INTERNATIONAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GRAVITAS MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HALYARD HEALTH, INC. |
|
SUBSTANTIALLY EQUIVALENT - KIT
|
1
|
HANGZHOU PRIMECARE MEDICAL CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HOLLISTER, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
SUBSTANTIALLY EQUIVALENT - KIT
|
2
|
HOSPI CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
IMED TECHNOLOGY, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KENTEC MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KIMBERLY-CLARK CORPORATION |
|
SUBSTANTIALLY EQUIVALENT - KIT
|
1
|
MANUFACTURING & RESEARCH, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MAQUET CRITICAL CARE AB |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MAXTER CATHETERS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDCAPTAIN LIFE SCIENCE CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDICAL INNOVATION DEVELOPMENT |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDLINE INDUSTRIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MRI MANUFACTURING AND RESEARCH, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NASER DIB GABINET LEKARKSI NASMED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NASOGASTRIC FEEDING SOLUTIONS, LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NEOCHILD, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NEOMED, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
OLYMPUS MEDICAL SYSTEMS CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PROSYS INTERNATIONAL LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RESHAPE LIFESCIENCES |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
SAINATH INTELLECTUAL PROPERTIES, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
SUBSTANTIALLY EQUIVALENT - KIT
|
2
|
SHANDONG WEIGAO GROUP MEDICAL POLYMER CO.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
STANDARD BARIATRICS |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
STANDARD BARIATRICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SYNCRO MEDICAL INNOVATIONS, INC. |
|
SUBSTANTIALLY EQUIVALENT - KIT
|
1
|
|
SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS
|
1
|
THE METRIX COMPANY |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TOOLS FOR SURGERY, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
URESIL, LLC |
|
SUBSTANTIALLY EQUIVALENT - KIT
|
1
|
VERITRACT, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WELL LEAD MEDICAL CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WILSON-COOK MEDICAL, INC |
|
SUBSTANTIALLY EQUIVALENT - KIT
|
2
|
XERIDIEM MEDICAL DEVICES |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
|
Recalls |
Manufacturer |
Recall Class |
Date Posted |
1 |
AbbVie Inc. |
II |
May-31-2017 |
2 |
AbbVie Inc. |
II |
Dec-17-2016 |
3 |
Abeon Medical Corporation |
II |
Jan-21-2016 |
4 |
Applied Medical Technology Inc |
II |
Jun-28-2024 |
5 |
Applied Medical Technology Inc |
III |
Feb-17-2017 |
6 |
Applied Medical Technology Inc |
II |
Apr-14-2016 |
7 |
Avanos Medical, Inc. |
II |
Jul-23-2024 |
8 |
Avanos Medical, Inc. |
I |
Mar-01-2024 |
9 |
Avanos Medical, Inc. |
I |
May-13-2022 |
10 |
Avanos Medical, Inc. |
II |
Feb-07-2022 |
11 |
Avanos Medical, Inc. |
II |
Dec-07-2020 |
12 |
Avanos Medical, Inc. |
II |
Sep-17-2020 |
13 |
Avanos Medical, Inc. |
II |
Nov-14-2019 |
14 |
Boston Scientific Corp |
II |
Jun-25-2015 |
15 |
Boston Scientific Corp |
II |
Jan-28-2009 |
16 |
Boston Scientific Corporation |
II |
Apr-11-2024 |
17 |
C R Bard Inc |
II |
Apr-08-2009 |
18 |
C.R. Bard Access Systems, Inc |
II |
Sep-15-2009 |
19 |
C.R. Bard Inc |
II |
Jan-25-2024 |
20 |
C.R. Bard, Inc., Urological Division |
III |
Nov-26-2010 |
21 |
CORPAK MedSystems, Inc. |
II |
May-25-2017 |
22 |
COVIDIEN LLC |
II |
Dec-11-2018 |
23 |
Churchill Medical Systems, Inc. |
III |
Mar-24-2010 |
24 |
Convatec Inc. |
I |
Jun-13-2014 |
25 |
Convatec Inc. |
III |
Aug-20-2013 |
26 |
Cook Endoscopy |
II |
Sep-01-2009 |
27 |
Cook Inc. |
II |
Mar-01-2018 |
28 |
Corpak Med Systems |
II |
Feb-22-2012 |
29 |
Covidien LLC |
II |
Feb-20-2018 |
30 |
Covidien LLC |
II |
Mar-02-2016 |
31 |
Ethox International, Inc. |
III |
Nov-22-2011 |
32 |
Hollister Incorporated |
II |
Mar-26-2021 |
33 |
Kimberly-Clark Corporation |
II |
Sep-20-2012 |
34 |
Kimberly-Clark Corporation |
II |
Feb-02-2012 |
35 |
MEDLINE INDUSTRIES, LP - Northfield |
II |
Sep-06-2024 |
36 |
Neomed Inc |
III |
Nov-30-2018 |
37 |
Teleflex Medical |
II |
Apr-24-2014 |
38 |
Teleflex Medical Europe Ltd |
II |
Apr-12-2018 |
|
|
|
|