19 results · 23ms · Sources: EU EUDAMED, 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