6 results
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10ms
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Sources: EU EUDAMED, US FDA
TLC Self-Retaining Retractor Frames SINGLE USE ONLY Rx ONLY (USA) Indicated to aid in tissue retraction during a surgical procedure.
FDA Recall
Terminated
·Abeon Medical Corporation·Product code FFO·November 25, 2015
TLC Self Retaining Retractor System Contents 1-RETRACTOR FRAME 6-ELASTIC STAYS STERILE EO Rx ONLY. Indicated for use in the retraction of soft tissue away from the operative surface.
FDA Recall
Terminated
·Abeon Medical Corporation·Product code FFO·November 25, 2015
B Braun 9F (O/S) Locking Tearway Introducers non-sterile. Catalog number 614008. The product is packaged as 50 bulk nonsterile units per pouch, 2 pouches per shipping carton.
FDA Recall
Terminated
·B. Braun Medical, Inc.·Product code DYB·May 8, 2006
Alive ECG App 2.1.2 ( a medical device application for the Apple iOS operating system, intended to be used with the AliveCor Heart Monitor. The AliveCor Heart Monitor is intended to record, store and transfer single-channel electrocardiogram (ECG) rhythms. The AliveCor Heart Monitor also displays ECG rhythms and detects the presence of atrial fibrillation and normal sinus rhythm (when prescribed or used under the care of a physician).
FDA Recall
Terminated
·Alivecor SFO·Product code DXH·January 9, 2015
OLYMPUS ShockPulse-SE Lithotripsy System, Model SPL-T Transducer
FDA Recall
Terminated
·Olympus Corporation of the Americas·Product code FEO·April 23, 2020
Sterile Custom Packs to be used in surgical procedures.
FDA Recall
Terminated
·American Contract Systems Jackson Pointe Commerce·Product code FBO·April 13, 2020