5 results
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18ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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Cook Urological, Inc. Koyle Diaper Stent 6.0 Fr, Sterile, GPN G17667, REF KDSCF-060050.
FDA Recall
Terminated
·Vance Products Inc. dba Cook Urological Inc. & Cook OB/GYN·Product code KOD·December 13, 2010
Medfusion Syringe Pump, Model 3500-0600-XX: a) 0600-00; b) 0600-01; c) 0600-50; d) 0600-51; e) 0600-82; f) 0600-249; software versions: v3, v4, v5, and v6
FDA Recall
Open, Classified
·Smiths Medical ASD Inc.·Product code FRN·August 16, 2023
Applied Medical's Inzii 12/15mm Retrieval System. Applieds Inzii Tissue Retrieval Bag, Model Number CD004, is classified as a Class II device. It was cleared to market via 510(k) filing K060051. The retrieval bag is a disposable specimen retrieval bag intended for use as receptacle for the collection of tissue, organs, and calculi during laparoscopic procedures. Applieds CD004 has a shelf life of three years. It is provided sterile and packaged in a heat sealed Tyvek pouch.
FDA Recall
Terminated
·Applied Medical Resources Corp 22872 Avenida Empresa # 3 Rancho Santa·Product code GCJ·October 21, 2013
Medfusion Syringe Pump Models: 3500, 3500-0600-00, 3500-0600-01, 3500-0600-249, 3500-0600-50, 3500-0600-51, 3500-0600-82, 3500-306, 3500-402, 3500-414, 3500-415, 3500-500, 3500BC, 3500E, 3500G, 3500SD, 3500SD-500, 3500VX, 3500VX-306, 3500VX-414, 3500VX-415, 3500VX-500, 3500ZE, Software Versions 6.0.0, 6.0.1
FDA Recall
Open, Classified
·Smiths Medical ASD Inc.·Product code FRN·April 18, 2022
Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500
FDA Recall
Open, Classified
·Smiths Medical ASD Inc.·Product code FRN·December 19, 2023