16 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SHEFFIELD BRAND WARMING LUBRIGEL PERSONAL LUBRICANT
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
KMEDIC
FDA UDI
TELEFLEX INCORPORATED·24026704283754·
PILLING
FDA UDI
TELEFLEX INCORPORATED·24026704506297·
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809849837·FOR MEN 15-20 MM HG KNEE HIGH OPEN TOE LARGE KH...
AG exhasust gas outlet assembly
FDA UDI
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06944904000237·
STRYKER PLATING SYSTEM BASIC FRAGMENT SET
FDA 510(k)
FDA Class 2
·Orthopedic
STRYKER T4 URETHANE HOOD; STRYKER T4 URETHANE ZIPPER TOGA; STRYKER T4 URETHANE PULLOVER TOGA
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
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
VALEO VASCULAR STENT
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code FGE·September 3, 2010
ACCU-CHEK SPIRIT COMBO
FDA Adverse Event
Malfunction
·ROCHE DIABETES CARE AG·Product code LZG·April 11, 2013
VITALITY
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 12, 2011
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·May 20, 2008
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Product Usage: Boston Scientific cardiac resynchronization therapy defibrillators (CRT-Ds) are indicated for patients with moderate to severe heart failure who remain symptomatic despite stable, optimal heart failure drug therapy and have left ventricular dysfunction and QRS duration > or equal to 120 ms. This family of pulse generators provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Cardiac Resynchronization Therapy (CRT), which treats heart failure by resynchronizing ventricular contractions through biventricular electrical stimulation; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 29, 2014