11 results
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11ms
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Sources: EU EUDAMED, US FDA
Teleflex HORIZON Microclip Titanium Ligating Clips w/tape, REF 005200; for use in general surgical procedures that require vessel or tissue ligation
FDA Enforcement
Class II
·Ongoing·TELEFLEX LLC·June 7, 2023
TELEFLEX LLC Arrow Central Venous Catheter Kit 16, 18 Gauge Multi Lumen Model Number:CDC-45703-XP1A (Model Numbers # IPN035619, IPN036437, IPN922677)
FDA Enforcement
Class II
·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·August 31, 2022
Pilling LOWSLEY PROSTATIC TRACTOR CVD, REF 243200; retractor
FDA Enforcement
Class II
·Ongoing·TELEFLEX LLC·July 12, 2023
Pilling O'REILLY ESOPHAGEAL RETRACTOR, REF 381801A; ENT retractor
FDA Enforcement
Class II
·Ongoing·TELEFLEX LLC·July 12, 2023
Pilling LOWSLEY PROSTATIC TRACTOR STR, REF 243201; retractor
FDA Enforcement
Class II
·Ongoing·TELEFLEX LLC·July 12, 2023
Endotracheal Tube labeled as the following: a. Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff; b. Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff; c. Flexiset Super Safety Clear Tracheal Tube, oral/nasal with Cuff and Insertion Aid; d. RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill; e. RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Murphy. Intended for patients requiring endotracheal intubation
FDA Enforcement
Class II
·Ongoing·TELEFLEX LLC·February 1, 2023
Teleflex Medical RUSCH Pocket Pac i.c. Closed System Intermittent Catheter Kit, 14 Fr (4.7mm), REF 10096140 (IPN050116). Urinary catheter.
FDA Enforcement
Class II
·Ongoing·TELEFLEX LLC·November 23, 2022
Endotracheal Tube labeled as the following: a. Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal; b. Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff; c. RUSCHELIT Super Safety Clear Tracheal Tube, oral/nasal, Murphy. Intended for patients requiring endotracheal intubation
FDA Enforcement
Class II
·Ongoing·TELEFLEX LLC·February 1, 2023
Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal. Intended for patients requiring endotracheal intubation
FDA Enforcement
Class II
·Ongoing·TELEFLEX LLC·February 1, 2023
Teleflex (manufacturer: Vascular SOLUTIONS) D-Stat Flowable Hemostat, REF 4000; for sealing residual oozing of tissue tracts of femoral access sites that have been previously closed by suture/collagen-based hemostatic devices.
FDA Enforcement
Class II
·Ongoing·TELEFLEX LLC·May 24, 2023
Pilling Wecksorb Cylindrical Sponges
FDA Enforcement
Class II
·Ongoing·TELEFLEX LLC·January 4, 2023