9 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PEARLESCENT POWDER FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA (YELLOW, RED, GREEN, BLACK, BLUE)
FDA 510(k)
FDA Class 1
·General Hospital
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690198666·AK3 Ultra Insert Trial Size 4, 11mm
SHENLING ACUPUNCTURE NEEDLES
FDA 510(k)
FDA Class 2
·General Hospital
HP-ONE
FDA 510(k)
FDA Class 1
·Microbiology
M2A-MAGNUM PF CUP 52ODX46ID
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·May 3, 2013
FLAIR ENDOVASCULAR STENT GRAFT
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code MIH·September 5, 2014
KINETRA
FDA Adverse Event
Malfunction
·MEDTRONIC EUROPE SARL·Product code MHY·May 2, 2011
GE Healthcare, SIGNA Excite 3.0T. MR System for use as a diagnostic imaging device.
FDA Enforcement
Class II
·Terminated·GE Healthcare·November 18, 2015
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