| FiberOptix(R) IAB | 10801902172843 | Arrow International LLC (Subsidiary of Teleflex Incorporated) | Class III | |
| FiberOptix(R) IAB | 10801902172867 | Arrow International LLC (Subsidiary of Teleflex Incorporated) | Class III | |
| FiberOptix(R) IAB | 10801902172881 | Arrow International LLC (Subsidiary of Teleflex Incorporated) | Class III | |
| FiberOptix(R) IAB | 10801902216776 | Arrow International LLC (Subsidiary of Teleflex Incorporated) | Class III | |
| FiberOptix(R) IAB | 10801902216790 | Arrow International LLC (Subsidiary of Teleflex Incorporated) | Class III | |
| FiberOptix(R) IAB | 10801902216813 | Arrow International LLC (Subsidiary of Teleflex Incorporated) | Class III | |
| Intra-aortic balloon catheter set | 05901297104318 | Balton Sp. z o.o. | Class III | |
| Intra-aortic balloon catheter set | 05901297104806 | Balton Sp. z o.o. | Class III | |
| Intra-aortic balloon catheter set | 05901297126044 | Balton Sp. z o.o. | Class III | |
| Intra-aortic balloon catheter set | 05901297134070 | Balton Sp. z o.o. | Class III | |
| Intra-aortic balloon catheter set | 05901297134100 | Balton Sp. z o.o. | Class III | |
| Intra-aortic balloon catheter set | 05901297135015 | Balton Sp. z o.o. | Class III | |
| Intra-aortic balloon catheter set | 05901297135022 | Balton Sp. z o.o. | Class III | |
| Intra-aortic balloon catheter set | 05901297153491 | Balton Sp. z o.o. | Class III | |
| Intra-aortic balloon catheter set | 05901297153606 | Balton Sp. z o.o. | Class III | |
| Intra-aortic balloon catheter set | 05901297154832 | Balton Sp. z o.o. | Class III | |
| Intra-aortic balloon catheter set | 05901297154849 | Balton Sp. z o.o. | Class III | |
| Intra-aortic balloon catheter set | 05901297154870 | Balton Sp. z o.o. | Class III | |
| Intra-aortic balloon catheter set | 05901297315127 | Balton Sp. z o.o. | Class III | |
| Intra-aortic balloon catheter set | 05906868993193 | Balton Sp. z o.o. | Class III | |
| Intra-aortic balloon catheter set | 05906868993308 | Balton Sp. z o.o. | Class III | |
| Myosist™ | 18904224917306 | Meril Life Sciences Pvt. Ltd. | Class III | |
| Myosist™ | 18904224917313 | Meril Life Sciences Pvt. Ltd. | Class III | |
| Myosist™ | 18904224917320 | Meril Life Sciences Pvt. Ltd. | Class III | |
| RediGuard(R) IAB | 00801902002679 | Arrow International LLC (Subsidiary of Teleflex Incorporated) | Class III | |
| RediGuard(R) IAB | 00801902002686 | Arrow International LLC (Subsidiary of Teleflex Incorporated) | Class III | |
| RediGuard(R) IAB | 00801902136732 | Arrow International LLC (Subsidiary of Teleflex Incorporated) | Class III | |
| RediGuard(R) IAB | 00801902136749 | Arrow International LLC (Subsidiary of Teleflex Incorporated) | Class III | |
| RediGuard(R) IAB | 10801902145632 | Arrow International LLC (Subsidiary of Teleflex Incorporated) | Class III | |
| RediGuard(R) IAB | 10801902145649 | Arrow International LLC (Subsidiary of Teleflex Incorporated) | Class III | |
| RediGuard(R) IAB | 10801902145656 | Arrow International LLC (Subsidiary of Teleflex Incorporated) | Class III | |
| RediGuard(R) IAB | 10801902145663 | Arrow International LLC (Subsidiary of Teleflex Incorporated) | Class III | |
| RediGuard(R) IAB | 10801902172935 | Arrow International LLC (Subsidiary of Teleflex Incorporated) | Class III | |
| RediGuard(R) IAB | 10801902172942 | Arrow International LLC (Subsidiary of Teleflex Incorporated) | Class III | |
| RediGuard(R) IAB | 10801902172959 | Arrow International LLC (Subsidiary of Teleflex Incorporated) | Class III | |
| Ultra 8(R) IAB | 10801902142402 | Arrow International LLC (Subsidiary of Teleflex Incorporated) | Class III | |
| Ultra 8(R) IAB | 10801902172850 | Arrow International LLC (Subsidiary of Teleflex Incorporated) | Class III | |
| Ultra 8(R) IAB | 10801902172874 | Arrow International LLC (Subsidiary of Teleflex Incorporated) | Class III | |
| UltraFlex(TM) IAB | 00801902003751 | Arrow International LLC (Subsidiary of Teleflex Incorporated) | Class III | |
| UltraFlex(TM) IAB | 00801902136701 | Arrow International LLC (Subsidiary of Teleflex Incorporated) | Class III | |
| UltraFlex(TM) IAB | 10801902145618 | Arrow International LLC (Subsidiary of Teleflex Incorporated) | Class III | |
| UltraFlex(TM) IAB | 10801902145625 | Arrow International LLC (Subsidiary of Teleflex Incorporated) | Class III | |
| UltraFlex(TM) IAB | 10801902145731 | Arrow International LLC (Subsidiary of Teleflex Incorporated) | Class III | |
| UltraFlex(TM) IAB | 10801902145748 | Arrow International LLC (Subsidiary of Teleflex Incorporated) | Class III | |
| UltraFlex(TM) IAB | 10801902172904 | Arrow International LLC (Subsidiary of Teleflex Incorporated) | Class III | |
| UltraFlex(TM) IAB | 10801902172911 | Arrow International LLC (Subsidiary of Teleflex Incorporated) | Class III | |