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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
Device introducer, catheter
Product CodeDYB
Regulation Number 870.1340
Device Class 2


Premarket Reviews
ManufacturerDecision
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
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