FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K123213 |
BECTON DICKINSON & CO. |
BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE |
01/09/2013 |
K140591 |
BECTON DICKINSON & CO. |
BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE - INJECTOR |
05/14/2014 |
K130197 |
Becton, Dickinson and Company |
BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE - P55 |
02/27/2013 |
K201099 |
Becton, Dickinson and Company |
BD PhaSeal Optima Closed System Drug Transfer Device |
08/12/2020 |
K181221 |
Becton, Dickinson and Company |
BD PhaSeal Optima Closed System Transfer Device |
11/30/2018 |
K223076 |
CareFusion |
BD TexiumÖ Closed Male Luer |
03/24/2023 |
K231888 |
Carefusion |
BD TexiumÖ Needle-Free Syringe |
09/25/2023 |
K192075 |
Epic Medical Pte. Ltd. |
ProSealÖ Closed System drug Transfer Device (CSTD) |
08/07/2020 |
K132899 |
EQUASHIELD MEDICAL LTD |
EQUASHIELD CLOSED SYSTEM DRUG TRANSFER DEVICE (CSTD) |
05/13/2014 |
K150219 |
EQUASHIELD MEDICAL LTD |
Equashield Closed System drug Transfer Device (CSTD) |
11/05/2015 |
K170706 |
Equashield Medical Ltd. |
Equashield Closed System drug Transfer Device (CSTD) |
07/03/2017 |
K221513 |
EQUASHIELD Medical Ltd. |
Equashield Closed System Transfer Device |
02/17/2023 |
K190157 |
ICU Medical |
Diana ChemoClave Transfer Set |
10/23/2019 |
K131549 |
ICU MEDICAL INC |
CHEMOLOCK, CHEMOLOCK PORT |
07/26/2013 |
K170110 |
ICU MEDICAL INC |
Diana Medication Transfer Set |
08/10/2018 |
K173477 |
ICU Medical, Inc. |
ChemoCLAVE Cytotoxic Medication Preparation and Delivery System |
08/31/2018 |
K180574 |
J & J Solutions, Inc. d/b/a/ Corvida Medical |
Halo Closed Vial Adaptor (Multiple Models based on 13, 20 or 28mm Vial Neck Size), Halo Closed Syringe Adaptor, Halo Closed Line Adaptor, Closed Vial Adaptor |
08/17/2018 |
K150486 |
J & J Solutions, Inc. d/b/a/Corvida Medical |
Halo |
07/24/2015 |
K172499 |
JMS North America Corporation |
NEOSHIELD |
06/01/2018 |
K201460 |
Shinva Ande Healthcare Apparatus Co., Ltd. |
Closed System Transfer Device |
11/23/2022 |
K192866 |
Simplivia Healthcare Ltd. |
Chemfort CSTD |
05/07/2020 |
K231286 |
Simplivia Healthcare LTD. |
Chemfort« Catheter Adaptor |
08/02/2023 |
K210707 |
Simplivia Healthcare LTD. |
OnGuard2 Chemfort Closed Administration (CADM) |
09/23/2021 |
K201142 |
Simplivia Healthcare Ltd. |
TEVADAPTOR Bag Adaptor LL, TEVADAPTOR Bag Adaptor LL with ULTRASITE, TEVADAPTOR Bag Adaptor SP with ULTRASITE, TEVADAPTOR IV Secondary Safety Set with ULTRASITE, TEVADAPTOR IV Secondary Safety set |
02/25/2021 |
K170680 |
Teva Medical Ltd., Migada Plant |
TEVADAPTOR Closed Drug Reconstitution and Transfer System |
05/16/2017 |
K180489 |
Teva Medical Ltd., Migada Plant |
TEVADAPTOR Closed Drug Reconstitution and Transfer System |
09/21/2018 |
K141448 |
TEVA MEDICAL LTD., MIGADA PLANT |
TEVADAPTOR CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM |
01/23/2015 |
K201422 |
Yukon Medical, LLC |
Arisure Closed System Drug Transfer Device (CSTD) |
03/02/2021 |