44 results
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17ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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Autosampler, Models: SIL-20ACXR CL, SIL-20ACHT CL, SIL-30AC CL
FDA Recall
Open, Classified
·Product code KIE·October 9, 2024
Autosampler, Models: SIL-40C XR CL, SIL-40C X3 CL
FDA Recall
Open, Classified
·Product code KIE·October 9, 2024
Olympic Cool-Cap System is intended to provide treatment for neonatal hypoxic-ischemic encephalopathy (HIE). The Cool-Cap is indicated for use in full term infants (more than 36 week gestational age) with clinical evidence of moderate to severe HIE. The device provides selective head cooling with mild systemic hypothermia to prevent or reduce the severity of neurologic injury associated with HIE. It is a selective head cooling system for treatment of neonatal hypoxic-ischemic encephalopathy (HIE) in infants. A cooling water cap is placed on the infant's head and the body is warmed using radiant warmers. The Cool-Cap provides 72 hours of monitored cooling. The device is labeled in part: "***OLYMPIC COOL-CAP Cooling Unit***Model No.***Made in USA***Software in this product is Natus Medical Incorporated***"
FDA Recall
Terminated
·Natus Medical Incorporated·Product code MXM·May 21, 2012
Fancy i Color cosmetic lens, Contents: A pair of sterile soft color contact lens immersed in buffered isotonic saline solution, Size: B.C. 8.6mm DIA. 14.5mm. Dreamcon Co. LTD. Korea.
FDA Recall
Terminated
·Kim's Trading Inc·Product code LPM·May 17, 2010
CareLink SmartSync Device Manager (24970A). used to interrogate cardiac implantable electronic devices (CIED).
FDA Recall
Open, Classified
·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·Product code OSR·April 6, 2021
Hipstar V40 Femoral Stem-127 degrees; N degrees 3 high offset 31 mm;Sterile; Catalog No: 7850-5-012, IMPLANT SIZE 12, Howmedica,Benoist Girard dt Cie, 203 bd de la Grande Della B.P.8;14291 Herouville Saint Clair
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code LPH·September 28, 2007
Hipstar V40 Femoral Stem-127 degrees; N degrees 3 high offset 31 mm;Sterile; Catalog No: 7850-5-010, IMPLANT SIZE 10, Howmedica,Benoist Girard dt Cie, 203 bd de la Grande Della B.P.8;14291 Herouville Saint Clair
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code LPH·September 28, 2007
Hipstar V40 Femoral Stem-127 degrees; Catalog No: 7850-5-001, N degrees 3 high offset 31 mm;Sterile; IMPLANT SIZE 1, Howmedica,Benoist Girard dt Cie, 203 bd de la Grande Della B.P.8;14291 Herouville Saint Clair
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code LPH·September 28, 2007
Hipstar V40 Femoral Stem-127 degrees; N degrees 3 high offset 31 mm;Sterile; Catalog No: 7850-5-009, IMPLANT SIZE 9, Howmedica,Benoist Girard dt Cie, 203 bd de la Grande Della B.P.8;14291 Herouville Saint Clair
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code LPH·September 28, 2007
Hipstar V40 Femoral Stem-127 degrees; N degrees 3 high offset 31 mm;Sterile; Catalog No: 7850-5-011, IMPLANT SIZE 11 , Howmedica,Benoist Girard dt Cie, 203 bd de la Grande Della B.P.8;14291 Herouville Saint Clair
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code LPH·September 28, 2007
Hipstar V40 Femoral Stem 127 degrees; N degrees 3 high offset 31 mm;Catalog No: 7850-5-004, IMPLANT SIZE 4 , Sterile; Howmedica,Benoist Girard dt Cie, 203 bd de la Grande Della B.P.8;14291 Herouville Saint Clair
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code LPH·September 28, 2007
Hipstar V40 Femoral Stem-127 degrees; N degrees 3 high offset 31 mm; Catalog No:7850-5-003, IMPLANT SIZE 3,Sterile; Howmedica,Benoist Girard dt Cie, 203 bd de la Grande Della B.P.8;14291 Herouville Saint Clair
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code LPH·September 28, 2007
Hipstar V40 Femoral Stem-127 degrees; N degrees 3 high offset 31 mm;Catalog No: 7850-5-005, IMPLANT SIZE 5, Sterile; Howmedica,Benoist Girard dt Cie, 203 bd de la Grande Della B.P.8;14291 Herouville Saint Clair
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code LPH·September 28, 2007
Hipstar V40 Femoral Stem-127 degrees; N degrees 3 high offset 31 mm;Sterile; Catalog No: 7850-5-007, IMPLANT SIZE 7, Howmedica, Benoist Girard dt Cie, 203 bd de la Grande Della B.P.8;14291 Herouville Saint Clair
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code LPH·September 28, 2007
Hipstar V40 Femoral Stem-127 degrees; N degrees 3 high offset 31 mm;Sterile; Catalog No: 7850-5-008, IMPLANT SIZE 8 , Howmedica,Benoist Girard dt Cie, 203 bd de la Grande Della B.P.8;14291 Herouville Saint Clair
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code LPH·September 28, 2007
Hipstar V40 Femoral Stem-127 degrees; N degrees 3 high offset 31 mm; Catalog No: 7850-5-002 ,IMPLANT SIZE 2 ,Sterile; Howmedica,Benoist Girard dt Cie, 203 bd de la Grande Della B.P.8;14291 Herouville Saint Clair
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code LPH·September 28, 2007
Hipstar V40 Femoral Stem 127 degrees; N degrees 3 high offset 31 mm;Sterile; Catalog No: 7850-5-006, IMPLANT SIZE 6 , Howmedica,Benoist Girard dt Cie, 203 bd de la Grande Della B.P.8;14291 Herouville Saint Clair
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code LPH·September 28, 2007
CELL-DYN 1700, list numbers 03H5301 and 03H53-03, manufactured by Abbott Hematology, Santa Clara, CA
FDA Recall
Terminated
·Abbott Laboratories·Product code gkz·June 8, 2009
CELL-DYN 1800, list numbers 07H77-01, 07H77-03, manufactured by Abbott Hematology, Santa Clara, CA
FDA Recall
Terminated
·Abbott Laboratories·Product code gkz·June 8, 2009
CELL-DYNE 1700CS (Closed Sampler), list numbers 03H57-01, 03H57-03, manufactured by Abbott Hematology, Santa Clara, CA
FDA Recall
Terminated
·Abbott Laboratories·Product code gkz·June 8, 2009