11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·January 9, 2014
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450748787·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450547380·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450545744·
VITALSAT PULSE OXIMETER, MODEL IC32000
FDA 510(k)
FDA Class 2
·Cardiovascular
PRIMA III TOTALSENSE TORSO COIL
FDA 510(k)
FDA Class 2
·Radiology
3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 24MM
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code HWC·May 3, 2013
TENDRIL STS
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC. CRMD·Product code DTB·January 14, 2014
DRILL, AO 4,2X340 MM
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·May 5, 2011
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