10 results
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28ms
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Sources: EU EUDAMED, US FDA
CINOXACIN 100 MCG. SENSITIVITY DISCS
FDA 510(k)
FDA Class 2
·Microbiology
DURAFORM
FDA UDI
Cerenovus, Inc.·10886704036685·DURAFORM Dural Graft Implant 1 Inches x 3 Inche...
ExoAtlet-II
FDA 510(k)
FDA Class 2
·Physical Medicine
HERO, VERSION 2.0
FDA 510(k)
FDA Class 2
·Cardiovascular
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 8, 2014
MRS HUMERAL STEM 7X 75MM
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS LIMERICK·Product code HSD·October 12, 2012
OT ULTRAMINI
FDA Adverse Event
Injury
·LIFESCAN, INC.·Product code NBW·August 16, 2010
CODMAN DURAL GRAFT IMPLANT, MODELS 80-1471, 80-1472, 80-1473, 80-1474, 80-1475, 80-1476, 80-1477, 80-1478, 80-1480, 80-1
FDA 510(k)
FDA Class 2
·Neurology
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021
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