9 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NEO-STAT CO2 <KG
FDA 510(k)
FDA Class 2
·Anesthesiology
GELCLAIR CONCENTRATED ORAL GEL
FDA 510(k)
FDA Unclassified
·Unknown
OVARIAL BIOPSY SET 324102-324108; OVARIAL BIOPSY SET 324200-324202; OVARIAL BIOPSY NEEDLE 32218
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
FDA Adverse Event
Death
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code MAX·December 18, 2019
SETROX S 60
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code NVN·April 29, 2013
SPRINT FIDELIS
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·May 10, 2011
ENDOPATH XCEL BLADELESS TROCAR WITH STABILITY SLEEVE - 12 MM DIAMETER, 100 MM LE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC·Product code GCJ·July 24, 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