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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REPROCESSED HARMONIC SCALPEL
FDA 510(k)
FDA Unclassified
·Unknown
Kalitec Universal Instruments
FDA UDI
Kalitec Direct LLC·B07301K0380600·Egg Handle, Threaded, 1.5"
PLASMAKINETIC GENERATOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ICS MEDICAL MODEL VG-30 VIDEO GOGGLES
FDA 510(k)
FDA Class 2
·Neurology
SETROX S 53
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code NVN·April 29, 2013
SM104 M-SERIES W/5TH WHEEL
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·March 28, 2011
HIRES 90K
FDA Adverse Event
Malfunction
·ADVANCED BIONICS, LLC·Product code MCM·March 7, 2008
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014
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