46 results
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15ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Endoscopic Introducer/Extractor
FDA Enforcement
Class II
·Terminated·Cook Inc.·June 21, 2017
Latex Dental Dams labeled as Non-Latex Dental Dams
FDA Recall
Terminated
·Coltene Whaledent Inc·Product code EIE·December 11, 2013
NEEDLEZAP, a battery operated needle destruction device. The product is labeled and marketed for use only in the law enforcement market or veterinary market.
FDA Recall
Terminated
·E Med Future Inc·Product code MTV·August 15, 2002
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
Cannulaide, Model 101. The Cannulaide product is composed of die-cut hydrocolloid coated polyurethane film with an integral hook strip (i.e., Velcro) to allow for the use of a loop material to help secure a nasal interface. The Cannulaide is applied under and over the nose of infants to provide a protective barrier to the philtrum, columella, septum, nares, and tip of nose. It is available in multiple sizes that vary the external geometry and nare hole size and spacing to allow for use on infants ranging from less than 700 grams to greater than 3000 grams. It is a non sterile, single patient use, disposable device.
FDA Enforcement
Class II
·Terminated·Beevers Manufacturing & Supply, Inc.·December 10, 2014
Harvest Graft Delivery System; Model Number: GDP-10 Product Usage: The Harvest Graft Delivery System is intended for the aspiration of bone marrow, autologous blood, plasma, or other body fluids. The system is indicated for die delivery of allograft, autograft, or synthetic bone graft materials to an orthopedic surgical site. In addition, it is designed to facilitate pre-mixing of bone graft materials with the aspirate(s), I.V. fluids, blood, plasma, platelet rich plasma, bone marrow or other specific blood component(s) as deemed necessary by the clinical use requirements.
FDA Enforcement
Class II
·Terminated·Harvest Technologies Corporation·October 23, 2013