151 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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WECK IMA/ENT Blade Electrode (1.9 cm), REF 809335, Rx Only Sterile, Teleflex Medical, RTP, NC The blade electrode is used in a wide variety of surgical procedures. The most common uses for electrodes with extended insulation is in cardiac bypass surgery (used in the take-down of the internal mammary artery or IMA) and ear, nose and throat surgery. They are sold non-sterile and are used one time and then disposed.
FDA Recall
Terminated
·Telefelx Medical·Product code GEI·July 30, 2010
SHERPA NX ACTIVE GUIDING CATHETER, 6F, IMA, 100CM, 070", REF SA6IMA. for cardiovascular use
FDA Recall
Terminated
·Medtronic Vascular·Product code DQY·March 15, 2019
SHERPA NX ACTIVE GUIDING CATHETER, 6F, IMA 55CM .070", REF SA6IMAK. for cardiovascular use
FDA Recall
Terminated
·Medtronic Vascular·Product code DQY·March 15, 2019
SHERPA NX ACTIVE GUIDING CATHETER, 6F, IMA, 90CM, 070", REF SA6IMAD . for cardiovascular use
FDA Recall
Terminated
·Medtronic Vascular·Product code DQY·March 15, 2019
SHERPA NX ACTIVE GUIDING CATHETER, 6F, IMA SH, 100CM, 070", REF SA6IMASH. for cardiovascular use
FDA Recall
Terminated
·Medtronic Vascular·Product code DQY·March 15, 2019
SHERPA NX ACTIVE GUIDING CATHETER, 6F, IMA SH, 60CM, 070", REF SA6IMASHJ. for cardiovascular use
FDA Recall
Terminated
·Medtronic Vascular·Product code DQY·March 15, 2019
CATHETER LA7IMAA LA 7F 110CM I CATHETER LA7IMAA LA 7F 110CM IMA Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: LA7IMAA
FDA Recall
Terminated
·Medtronic, Inc.·Product code DQY·April 5, 2006
Sysmex Stromatolyser-IM; a lytic reagent for use with the XE-2100, XE-2100L and XE-5000 Series Sysmex Automated Hematology Analyzers; the reagent solution is supplied in a 10-liter cubetainer (cardboard cube with a 10-liter plastic liner); Sysmex America, Inc., Mundelein, IL 60060; catalog number SIM-220A. The STROMATOLYSER-IM lysing reagent is used to destroy red blood cells to aid in the counting and characterization on immature white blood cells. This reagent is used on the Sysmex XE-Series and SE Series hematology analyzers.
FDA Recall
Terminated
·Sysmex America, Inc.·Product code GGK·April 11, 2011
Sysmex Stromatolyser-IM; a lytic reagent for use with the XE-2100, XE-2100L and XE-5000 Series Sysmex Automated Hematology Analyzers; the reagent solution is supplied in a 10-liter cubetainer (cardboard cube with a 10-liter plastic liner); Sysmex America, Inc., Mundelein, IL 60060; catalog number SIM-220A. The product is a lytic reagent used to lyse (destroy) red blood cells for hemoglobin determinations or aid in the counting of white blood cells.
FDA Recall
Terminated
·Sysmex America, Inc.·Product code GGK·June 23, 2009
3M Micropore Paper Tape, Cat. No. 1530-154, 1 in x 54 in., 800 rolls / case.
FDA Recall
Terminated
·Product code KGX·January 29, 2010
3M Micropore Paper Tape, Cat. No. 1530-15Y, 1 in x 5YDS., 441 rolls / case.
FDA Recall
Terminated
·Product code KGX·January 29, 2010
3M Micropore Paper Tape, Cat. No. 1530-336, 3 in x 36 in., 240 rolls / case.
FDA Recall
Terminated
·Product code KGX·January 29, 2010
3M Micropore Paper Tape, Cat. No. 1530-136, 1 in x 36 in., 800 rolls / case.
FDA Recall
Terminated
·Product code KGX·January 29, 2010
3M Micropore Paper Tape, Cat. No. 1530-118, 1 in x 18 in., 800 rolls / case.
FDA Recall
Terminated
·Product code KGX·January 29, 2010
3M Micropore Paper Tape, Cat. No. 1530-12Y, 1 in x 2YDS., 630 rolls / case.
FDA Recall
Terminated
·Product code KGX·January 29, 2010
3M Micropore Paper Tape, Cat. No. 1530-254, 2 in x 54 in., 400 rolls / case.
FDA Recall
Terminated
·Product code KGX·January 29, 2010
3M Micropore Single Use Rolls, Surgical Tape, REF 1530S-1, 1 in x 1-1/2 yd.
FDA Recall
Terminated
·Product code KGX·January 29, 2010
Brilliance iCT, Brilliance 64 and Brilliance Big Bore The Brilliance iCT, Brilliance 64 and Brilliance Big Bore are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·February 5, 2014
SOMATOM Force, System x-ray, tomography, computed
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·December 14, 2016
Large Stealth Chamber, Catalog Numbers: DS50-001-XL-T, DS50-002-XL-T, DS50-003-XL-T, DS50-102-XL-T, DS50-103-XL-T
FDA Recall
Terminated
·Iba Dosimetry·Product code IYE·April 26, 2017