10 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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XENO ADHESIVE WITH ACTIVATOR
FDA 510(k)
FDA Class 2
·Dental
VITROS IMMUNODIAGNOSTIC PRODUCTS FOLATE RANGE VERIFIERS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SCHOTTLANDER ENIGMA COLOUR TONE, MODEL 0156
FDA 510(k)
FDA Class 2
·Dental
I-STAT TROPONIN (CTNI) CARTRIDGE
FDA Adverse Event
Malfunction
·ABBOTT POINT OF CARE·Product code MMI·February 14, 2012
NANOTITE TM CERTAIN PREVAIL IMPLANT 4/5/4 X 15MM
FDA Adverse Event
Injury
·BIOMET 3I·Product code DZE·December 4, 2023
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
FDA Adverse Event
Injury
·MPRI·Product code LWP·April 10, 2013
UNKNOWN PRODUCT - KOOL GRIP MALLET - HD
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS LIMERICK·Product code LXH·April 4, 2011
SYNCHROMED EL
FDA Adverse Event
Malfunction
·RICE CREEK MFG·Product code LKK·May 21, 2008
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
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