8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Vydence Zye and Vydence One
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BIOMET BI-POLAR SHOULDER SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
HOME CARE VAREIOUS MODELS OF POWERED MUSCLE STIMULATOR, HT-311, HT-311N, HT-312
FDA 510(k)
FDA Class 2
·Physical Medicine
STOCKERT RF GENERATOR
FDA Adverse Event
Injury
·STOCKERT GMBH·Product code DRF·October 17, 2008
ADAPTA DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NVZ·August 11, 2011
GYNECARE TVT RETROPUBIC SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·July 2, 2013
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
EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·February 3, 2021