3 results
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17ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·September 7, 2022
Aqauapak 728 SW, 760 ML W/028 Adaptor, Intl, Product No. 403728; Aqauapak 1028 SW, 1070 ML/W028 Adaptor, Intl, Product No. 404128; Aqauapak 428 SW, 440 ML W/028 Adaptor, Intl, Product No. 404428; Aquapak 728 SW, 760 ML W/028 Adaptor, Product No. 037-28; Aquapak SW/EAU Sterile, 760 ML W/Adaptor, Product No. 037-28C; Aquapak 728 SW, 760 ML W/28 Adaptor, French, Product No. 037-02F; Aquapak 733 SW, 760 ML W/033 Adaptor, Product No. 037-33; Aquapak 735 HNS, 760 ML W/028 Adaptor, Product No. 037-35; Aquapak 739 FNS, 760 ML W/028 Adaptor, Product No. 037-39; Aquapak 0.9% NACL, 760 ML W/Adaptor, Product No. 037-39C; Aquapak 770 HNS, 760 ML W/033 Adaptor, Product No. 037-70; Aquapak 1028 SW, 1070 ML W/028 Adaptor, Product No. 041-28; Aquapak SW/EAU Sterile, 1070 ML W/Adaptor, Product No. 041-28C; Aquapak 1033 SW, 1070 ML W/033 Adaptor; Product No. 041-33; Aquapak 1035 HNS, 1070 ML W/028 Adaptor, Product Code 041-35; Aquapak 428 SW, 440 ML W/028 Adaptor, Product No. 044-28; Aquapak SW/EAU Sterile, 440 MLW/Adaptor, Product No. 044-28C; Aquapak 428 SW, 440 ML W/028 Adaptor, French, Product No. 044-28F; Aquapak 433 SW, 440 ML W/033 Adaptor, Product No. 044-33; Aquapak 435 HNS, 440 ML W/028 Adaptor, Product No. 044-35; Aquapak 470 HNS, 440 ML W/033 Adaptor, Product No. 044-70. Used in anesthesiology.
FDA Enforcement
Class II
·Terminated·Teleflex Medical·December 10, 2014
CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024