97 results
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28ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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V*Care Resuscitator Infant Resuscitator, VN 3000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.
FDA Recall
Terminated
·Ventlab Corporation·Product code BTM·July 11, 2012
Perouse Flamingo, Model 0218TA and 0218TB intended for use during cardiovascular procedure to create, maintain and monitor pressure in the balloon catheter.
FDA Recall
Terminated
·Perouse Medical 135, Route Neuve Irigny France·Product code MAV·May 10, 2012
AirFlow, Infant Resuscitator, AF3000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028 The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.
FDA Recall
Terminated
·Ventlab Corporation·Product code BTM·July 11, 2012
AirFlow Resuscitator, Adult Resuscitator, AF1000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028 The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.
FDA Recall
Terminated
·Ventlab Corporation·Product code BTM·July 11, 2012
Integra Advansys Medial Lisfranc Plate (MLP), Integra, 311 Enterprise Drive, Plainsboro, NJ 08536 The Advansys plates are intended for bone fixation such as: Arthrodesis of the 1st metatarsocuneiform joint to reposition and stabilize a metatarsus primus varus, Lisfranc arthrodesis, Mono or bi-cortical osteotomies or fractures near the 1st metatarsocuneiform joint.
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code HRS·February 9, 2012
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Catheter, 6", Part Number 2110-0503 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
FDA Recall
Terminated
·Orthovita, Inc., dBA Stryker Orthobiologics.·Product code OAR·November 10, 2012
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Reamer, 8", Part Number 2110-0525 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
FDA Recall
Terminated
·Orthovita, Inc., dBA Stryker Orthobiologics.·Product code OAR·November 10, 2012
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Catheter, 8", Part Number 2110-0526 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
FDA Recall
Terminated
·Orthovita, Inc., dBA Stryker Orthobiologics.·Product code OAR·November 10, 2012
Active Renin IRMA Kit, Part Number DSL25100 Product Usage: The Renin IRMA; DSL25100 immunoradiometric assay kit provides materials for the quantitative measurement of Renin in plasma. This assay is intended for in vitro diagnostic use.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code CIB·January 20, 2012
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Diamond Needle, 4", Part Number 2110-0506 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
FDA Recall
Terminated
·Orthovita, Inc., dBA Stryker Orthobiologics.·Product code OAR·November 10, 2012
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Beveled Needle, 6", Part Number 2110-0524 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
FDA Recall
Terminated
·Orthovita, Inc., dBA Stryker Orthobiologics.·Product code OAR·November 10, 2012
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger, 6", Part Number 2110-0501 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
FDA Recall
Terminated
·Orthovita, Inc., dBA Stryker Orthobiologics.·Product code OAR·November 10, 2012
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger Delivery System, 4", Part Number 2090-0501 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
FDA Recall
Terminated
·Orthovita, Inc., dBA Stryker Orthobiologics.·Product code OAR·November 10, 2012
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger, 8", Part Number 2110-0502 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
FDA Recall
Terminated
·Orthovita, Inc., dBA Stryker Orthobiologics.·Product code OAR·November 10, 2012
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Beveled Needle, 4", Part Number 2110-0505 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
FDA Recall
Terminated
·Orthovita, Inc., dBA Stryker Orthobiologics.·Product code OAR·November 10, 2012
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Reamer, 6", Part Number 2110-0504 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
FDA Recall
Terminated
·Orthovita, Inc., dBA Stryker Orthobiologics.·Product code OAR·November 10, 2012
Stat-Check Resuscitator, Adult Manual Emergency Resuscitator with A.C.E. /Stat-Check CO2 Indicator, SC 9000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.
FDA Recall
Terminated
·Ventlab Corporation·Product code BTM·July 11, 2012
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger Delivery System, 6", Part Number 2090-0505 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
FDA Recall
Terminated
·Orthovita, Inc., dBA Stryker Orthobiologics.·Product code OAR·November 10, 2012
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger Delivery System, 4", Part Number 2090-0502 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
FDA Recall
Terminated
·Orthovita, Inc., dBA Stryker Orthobiologics.·Product code OAR·November 10, 2012
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Syringe Delivery System, 6", Part Number 2090-0504 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
FDA Recall
Terminated
·Orthovita, Inc., dBA Stryker Orthobiologics.·Product code OAR·November 10, 2012