11 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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XIA 3 SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Caplugs/Evergreen
FDA UDI
CAPlugs·00810044206784·7" CHROM COLUMN MED FILTER
HEPARIN COATED MINIATURE CENTRIFUGAL BYPASS PUMP SYSTEM;MODEL #CP-1H
FDA 510(k)
FDA Class 2
·Cardiovascular
MAXILLARY DISTRACTOR
FDA 510(k)
FDA Class 2
·Dental
REBOUND HRD
FDA Adverse Event
Malfunction
·MINNESOTA MEDICAL DEVELOPMENT, INC.·Product code FTL·May 16, 2011
VERCISE? CARTESIA?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code MHY·March 23, 2026
WALLFLEX¿ BILIARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code FGE·April 29, 2013
MINI TREK CORONARY DILATATION CATHETER
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code LOX·May 10, 2011
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code NIQ·July 28, 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