40 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GORE-TEX SOFT TISSUE PATCH,MYCROMESHA BIOMATERIAL,DUALMESH BIOMATERIAL,DUALMESH BIOMATERIAL WITH HOLES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
FLIPPER DETACHABLE EMBOLIZATION COILS
FDA 510(k)
FDA Class 2
·Cardiovascular
SIGNA PET/MR
FDA 510(k)
FDA Class 2
·Radiology
FLIPPER 110 PDA CLOSURE COIL DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code KRD·January 2, 2017
MREYE FLIPPER PDA CLOSURE DETACHABLE EMBOLIZATION COIL
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code KRD·June 13, 2018
FLIPPER 110 PDA CLOSURE COIL DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code KRD·March 8, 2017
MREYE FLIPPER PDA CLOSURE DETACHABLE EMBOLIZATION COIL
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code KRD·March 8, 2017
HEARTSTART ON SITE
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 23, 2014
ADVANTA VXT
FDA Adverse Event
Injury
·ATRIUM MEDICAL CORP.·Product code DSY·January 2, 2013
UNKNOWN CONTINUUM HARD RIM BEARING IMPACTOR
FDA Adverse Event
Malfunction
·ZIMMER, INC.·Product code HWA·December 21, 2010
MREYE FLIPPER PDA CLOSURE DETACHABLE EMBOLIZATION COIL
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code KRD·February 7, 2017
MREYE FLIPPER PDA CLOSURE DETACHABLE EMBOLIZATION COIL
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code KRD·February 21, 2017
FLIPPER 110 PDA CLOSURE COIL DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code KRD·February 27, 2017
FLIPPER 110 PDA CLOSURE COIL DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code KRD·February 21, 2017
MREYE FLIPPER PDA CLOSURE DETACHABLE EMBOLIZATION COIL
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code KRD·February 21, 2017
Stryker PCA 10 Degree Hooded Acetabular Insert ID 22mm, Part of the Howmedica PCA Total Hip System intended for use during total hip arthroplasty. The acetabular insert is used in conjunction with PCA Acetabular Shells and Femoral Heads to restore hip joint biomechanics.
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·November 25, 2015
MREYE FLIPPER PDA CLOSURE DETACHABLE EMBOLIZATION COIL
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code KRD·February 27, 2017
FLIPPER 110 PDA CLOSURE COIL DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·WILL DAVIDSON LLP·Product code KRD·March 1, 2017
FLIPPER 110 PDA CLOSURE COIL DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code KRD·February 27, 2017
Stryker PCA 10 Degree Hooded Acetabular Insert ID 22mm, Part of the Howmedica PCA Total Hip System intended for use during total hip arthroplasty. The acetabular insert is used in conjunction with PCA Acetabular Shells and Femoral Heads to restore hip joint biomechanics.
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code JDI·October 15, 2015