19 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FLOWSCREEN, FLOWSCREEN/CORSCREEN, FLOWSCREEN CT
FDA 510(k)
FDA Class 2
·Anesthesiology
PIONEER SURGICAL TECHNOLOGY EXTENDED GTR, MODEL 501-601
FDA 510(k)
FDA Class 2
·Orthopedic
BRANAN MEDICAL CORPERATION MONITECT TCA DRUG SCREEN TEST, MODEL MC21 AND MD21
FDA 510(k)
FDA Class 2
·Clinical Toxicology
CERENOVUS ENTERPRISE
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code NJE·December 18, 2025
CERENOVUS ENTERPRISE
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code NJE·November 7, 2025
CERENOVUS ENTERPRISE
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code NJE·May 13, 2025
UNKNOWN TROFIX TROCHANTERIC FIXATION PLATE
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURER GMBH·Product code KTT·August 22, 2023
UNKNOWN TROFIX TROCHANTERIC FIXATION PLATE
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURER GMBH·Product code KTT·August 22, 2023
UNKNOWN TROFIX TROCHANTERIC FIXATION PLATE
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code KTT·August 22, 2023
UNKNOWN TROFIX TROCHANTERIC FIXATION PLATE
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code KTT·August 14, 2023
UNKNOWN TROFIX TROCHANTERIC FIXATION PLATE
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURER GMBH·Product code KTT·August 22, 2023
E SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·April 9, 2013
PROFEMUR(R) Z STEM PLASMA SPRAYED
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code LPH·May 6, 2011
PULSE GEN MODEL UNK
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·July 18, 2008
UNKNOWN TROFIX TROCHANTERIC FIXATION PLATE
FDA Adverse Event
Injury
·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code KTT·August 22, 2023
FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR
FDA Adverse Event
Death
·FRESENIUS HEMOCARE GMBH·Product code LKN·August 21, 2023
FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR
FDA Adverse Event
Death
·FRESENIUS HEMOCARE GMBH·Product code LKN·August 21, 2023
PROWLER SELECT
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code QJP·September 11, 2025
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