22 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STERITITE CONTAINER SYSTEM & MEDITRAY PRODUCTS
FDA 510(k)
FDA Class 2
·General Hospital
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306817533·Tebbetts Retractor, 24mm x 9cm
Fixation Forcep
FDA UDI
Medetz Surgical Instruments LLC·G2231106820·Castro Fixation Forceps OL 105mm(4 1/8")
GSP NEONATAL 17A-OH-PROGESTERONE KIT MODEL: 3305-001U
FDA 510(k)
FDA Class 1
·Clinical Chemistry
HELAX-TMS V 5.1 RADIATION THERAPY TREATMENT PLANNING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
DONJOY
FDA UDI
DJO, LLC·00888912003650·COLD PAD,UNIV LOOP,NS,EH,XL
BD POSIFLUSH¿ SF SALINE SYRINGE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND CO.·Product code NGT·November 18, 2022
LINEAR? ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·May 11, 2026
CONTOUR NEXT
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·November 22, 2021
CONTOUR NEXT
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·July 16, 2021
CONTOUR NEXT (CONNECTED)
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·April 29, 2021
CONTOUR NEXT
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·December 1, 2023
EON
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 10, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·September 23, 2014
STERLING ES PTA BALLOON DILATATION CATHETER
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LIT·June 1, 2011
CONTOUR NEXT
FDA Adverse Event
Injury
·ASCENSIA DIABETES CARE US INC.·Product code NBW·March 22, 2021
CONTOUR NEXT (CONNECTED)
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·March 27, 2020
CONTOUR NEXT (CONNECTED)
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·June 9, 2021
CONTOUR NEXT
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC.·Product code NBW·November 2, 2021
Video Duodenoscope
FDA Enforcement
Class II
·Terminated·Pentax Medical Company·June 8, 2016