16 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MSC LIPID CONTROL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CLINCARE LATEX SURGEON'S GLOVE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
RADIANALYZER, MODEL 12710
FDA 510(k)
FDA Class 2
·Cardiovascular
PASS LP
FDA Adverse Event
MEDICREA TECHNOLOGIES·Product code MNI·April 17, 2013
DEMEDIOX
FDA Adverse Event
Injury
·DEMETECH CORPORATION·Product code NEW·June 11, 2024
PASS LP
FDA Adverse Event
Injury
·MEDICREA INTERNATIONAL·Product code MNI·April 5, 2012
PASS LP
FDA Adverse Event
Injury
·MEDICREA TECHNOLOGIES·Product code MNI·April 17, 2013
UNKNOWN_RECONSTRUCTIVE_PRODUCT
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code JDI·April 29, 2013
GLUCOCARD 01 BLOOD GLUCOSE SYSTEM
FDA Adverse Event
Malfunction
·ARKRAY, INC.·Product code CGA·May 9, 2011
ACCU-CHEK SPIRIT
FDA Adverse Event
Malfunction
·DISETRONIC MEDICAL SYSTEMS·Product code LZG·July 23, 2008
DEMEDIOX
FDA Adverse Event
Injury
·DEMETECH CORPORATION·Product code NEW·February 23, 2024
DEMEDIOX
FDA Adverse Event
Injury
·DEMETECH CORPORATION·Product code NEW·February 23, 2024
DEMEDIOX
FDA Adverse Event
Injury
·DEMETECH CORPORATION·Product code NEW·July 3, 2024
DEMEDIOX
FDA Adverse Event
Injury
·DEMETECH CORPORATION·Product code NEW·May 9, 2024
DEMEDIOX
FDA Adverse Event
Injury
·DEMETECH CORPORATION·Product code NEW·February 23, 2024
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