13 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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ACE CANNULATED SELF TAPPING CANCELLOUS BONE SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
Map-iT
FDA UDI
ACCESS POINT TECHNOLOGIES, INC.·00818083017064·STR, 4 electrode, MPD-CS-L, 2mm electrode spacing
Sklar®
FDA UDI
SKLAR CORPORATION·10649111230806·LASER GRAVES SPEC XLG W/O TB
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515230095·Hook, extra fine .33mm hook ang 90deg, 6 1/8"
KJ SUBMERGED SYSTEM
FDA 510(k)
FDA Class 2
·Dental
BF-NAVI
FDA 510(k)
FDA Class 2
·Radiology
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·February 19, 2016
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC, INC.·Product code KWP·April 9, 2015
FORTIFY DR
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·June 30, 2014
HERO GRAFT
FDA Adverse Event
Injury
·HEMOSPHERE, INC.·Product code DSY·January 9, 2013
REALIZE ADJ GASTRIC BAND-C
FDA Adverse Event
Malfunction
·OBTECH MEDICAL SARL_·Product code LTI·November 20, 2010
MENTOR SMOOTH ROUND MODERATE PLUS PROFILE
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FWM·February 22, 2018
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