|
|
| Device |
introducer, catheter |
| Product Code | DYB |
| Regulation Number |
870.1340
|
|---|
| Device Class |
2
|
| Premarket Reviews |
|---|
| Manufacturer | Decision |
|---|
| ABBOTT MEDICAL |
| |
SUBSTANTIALLY EQUIVALENT
|
3
|
| ABIOMED INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
4
|
| ABIOMED, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| ACCESS SCIENTIFIC, LLC |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| ACUTUS MEDICAL INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| ACUTUS MEDICAL, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
4
|
| ARGON MEDICAL DEVICES |
| |
SUBSTANTIALLY EQUIVALENT
|
3
|
| ARGON MEDICAL DEVICES, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
4
|
| ATRICURE, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| BARD PERIPHERAL VASCULAR, INC |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| BAYLIS MEDICAL COMPANY INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
6
|
| BEIJING DEMAX MEDICAL TECHNOLOGY CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
2
|
| BIOCARDIA |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| BIOCARDIA, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| BIOSENSE WEBSTER, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| BOSTON SCIENTIFIC |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| BOSTON SCIENTIFIC CORPORATION |
| |
SUBSTANTIALLY EQUIVALENT
|
4
|
| C.R. BARD, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| C.R.BARD, INC |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| CENTERPOINT SYSTEMS LLC |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| CIRCA SCIENTIFIC, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| CONTRACT MEDICAL INTERNATIONAL GMBH |
| |
SUBSTANTIALLY EQUIVALENT
|
3
|
| COOK INCORPORATED |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| COOK MEDICAL |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| CORDIS CORPORATION |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| CORDIS US CORP. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| CURATIA MEDICAL CO. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| DIB ULTRANAV MEDICAL, LLC |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| EAST END MEDICAL I LLC |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| EAST END MEDICAL I, LLC |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| EDWARDS LIFESCIENCES |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| ENDOPHYS HOLDINGS LLC |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| FREUDENBERG MEDICAL LLC |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| FREUDENBERG MEDICAL MIS, INC |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| INARI MEDICAL, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
3
|
| INNEUROCO INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| KEYSTONE HEART, LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| MERIT MEDICAL SYSTEMS |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| MERIT MEDICAL SYSTEMS, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
2
|
| NUMED, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| OSCOR INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| RAM MEDICAL INNOVATIONS, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| SHANGHAI KINDLY MEDICAL INSTRUMENTS CO., LTD |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| SHANGHAI MICROPORT EP MEDTECH CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
2
|
| SURMODICS, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
2
|
| SYNAPTIC MEDICAL CORPORATION |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| TALON SURGICAL |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| TERUMO MEDICAL COPORATION |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| TERUMO MEDICAL CORPORATION |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| TRANSAORTIC MEDICAL, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| VIZARAMED, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
|
| Recalls |
| Manufacturer |
Recall Class |
Date Posted |
| 1 |
Abbott |
II |
Dec-27-2021 |
| 2 |
Abbott Medical |
II |
Jan-08-2020 |
| 3 |
Abbott Medical |
II |
Jan-07-2020 |
| 4 |
Abiomed, Inc. |
II |
Jan-05-2024 |
| 5 |
Abiomed, Inc. |
II |
Jul-11-2023 |
| 6 |
Acutus Medical Inc |
II |
Apr-23-2020 |
| 7 |
Angiodynamics Inc. (Navilyst Medical Inc.) |
II |
Apr-21-2021 |
| 8 |
Argon Medical Devices, Inc |
II |
Sep-21-2021 |
| 9 |
Argon Medical Devices, Inc |
II |
Feb-05-2021 |
| 10 |
Arrow International Inc |
II |
Feb-14-2020 |
| 11 |
Arrow International Inc |
II |
Sep-23-2019 |
| 12 |
Baylis Medical Company Inc. |
II |
May-21-2020 |
| 13 |
Biosense Webster, Inc. |
II |
Sep-02-2022 |
| 14 |
Biosense Webster, Inc. |
II |
Mar-22-2021 |
| 15 |
Biosense Webster, Inc. |
II |
Mar-13-2024 |
| 16 |
Biosense Webster, Inc. |
II |
Apr-01-2023 |
| 17 |
Boston Scientific Corporation |
II |
Mar-28-2024 |
| 18 |
Cook Inc. |
II |
Dec-16-2021 |
| 19 |
Cook Inc. |
II |
Oct-29-2021 |
| 20 |
Cook Inc. |
I |
Dec-23-2020 |
| 21 |
Cook Inc. |
II |
Feb-20-2019 |
| 22 |
Cook Incorporated |
II |
Apr-12-2024 |
| 23 |
Creganna Medical Devices |
II |
Jul-28-2023 |
| 24 |
Datascope Corp. |
II |
Jul-21-2023 |
| 25 |
Freudenberg Medical, Llc |
II |
Apr-28-2022 |
| 26 |
Galt Medical Corporation |
II |
Jun-15-2023 |
| 27 |
Medtronic Vascular Galway DBA Medtronic Ireland |
I |
May-27-2020 |
| 28 |
Merit Medical Systems, Inc. |
II |
Aug-12-2024 |
| 29 |
Merit Medical Systems, Inc. |
II |
Jun-27-2024 |
| 30 |
Merit Medical Systems, Inc. |
II |
May-20-2024 |
| 31 |
Merit Medical Systems, Inc. |
II |
May-10-2023 |
| 32 |
Merit Medical Systems, Inc. |
II |
Aug-12-2021 |
| 33 |
Merit Medical Systems, Inc. |
II |
Aug-10-2021 |
| 34 |
Merit Medical Systems, Inc. |
II |
May-11-2020 |
| 35 |
Oscor Inc. |
II |
Feb-17-2022 |
| 36 |
Oscor, Inc. |
II |
Apr-01-2021 |
| 37 |
St. Jude Medical |
II |
Jul-12-2024 |
| 38 |
Terumo Medical Corporation |
I |
May-28-2019 |
| 39 |
W. L. Gore & Associates Inc. |
II |
May-11-2020 |
|
|
|
|
