19 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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NEURO II-S
FDA 510(k)
FDA Class 2
·Radiology
PULSE
FDA UDI
Nuvasive, Inc.·00887517994141·PULSE Flat Array C, Beta
MedGyn Pessary Dish w/o support # 3
FDA UDI
MEDGYN PRODUCTS, INC.·M803050132·Dish Pessary is used to treat uterine prolapse.
APEX Revision Knee
FDA UDI
Omni Life Science, Inc.·00841690124771·Modular Stem 13mm x 125mm
Alleset
FDA UDI
GRI Medical & Electronic Technology Co., Ltd.·16931918174334·Yankauer Suction, Bulb Tip, Vented_ non-sterile...
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306810558·Mayo Scissors, Curved, 25cm
Alleset
FDA UDI
GRI Medical & Electronic Technology Co., Ltd.·16931918112084·Yankauer Suction, Bulb Tip, Vented_sterilize_50...
KLOCKNER DENTAL IMPLANTS, MODELS SK, NK, IK, S3, AND S4
FDA 510(k)
FDA Class 2
·Dental
ALLERGEN IMMUNOCAP, MODELS C74, E89, EX2, EX70, EX71, EX73, FX8, FX9, FX10, FX16, FX73, I72, I75, I76, K71, K73, K81, K8
FDA 510(k)
FDA Class 2
·Immunology
LIFESTENT VALEO BILIARY STENT
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code FGE·December 29, 2009
LIFESTENT VALEO BILIARY STENT
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code FGE·December 29, 2009
LIFESTENT VALEO VASCULAR STENT
FDA Adverse Event
Injury
·BARD PERIPHERAL VASCULAR, INC.·Product code FGE·August 9, 2010
FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFTS
FDA Adverse Event
Malfunction
·ANGIOMED GMBH & CO. MEDIZINTECHNIK·Product code JCT·May 22, 2009
CONFIDENCE SPINAL CEMENT SYSTEM
FDA Adverse Event
Injury
·DEPUY SPINE·Product code NDN·August 19, 2011
VALEO VASCULAR STENT
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code FGE·September 3, 2010
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·April 10, 2013
NAMIC/VA
FDA Adverse Event
Injury
·NAMIC/VA·Product code LJT·May 14, 2008
LIFEVEST WCD 3000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·April 5, 2011
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018