14 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SAFETOUCH PSV WINGED INFUSION SET WITH/WITHOUT FILTER
FDA 510(k)
FDA Class 2
·General Hospital
NexxZr™ T / D-100-30-NT-D200-SD
FDA UDI
SAGEMAX BIOCERAMICS, INC·00842271113634·
MOBIUS ULTRASOUND IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEFOTAXIME 0.5-64 UG/ML
FDA 510(k)
FDA Class 2
·Microbiology
FASTTAKE
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·March 27, 2002
FASTTAKE
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·September 22, 2003
ONE TOUCH ULTRA
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·January 15, 2003
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 4, 2024
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 1, 2014
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·May 29, 2013
TECNIS 1-PIECE
FDA Adverse Event
Malfunction
·ABBOTT MEDICAL OPTICS·Product code HQL·June 17, 2011
TRUEMETRIX
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH, INC.·Product code NBW·November 16, 2018
Savannah-T Straight Rod, 200mm, Part Number 10704-200; Savannah-T Straight Rod, 250mm, Part Number 10704-250; Savannah T-Straight Rod 300mm, Part Number 10704-300; Savannah-T Straight Rod, 400mm, Part Number 10704-400; Savannah-T Straight Rod, 500mm; Savannah-T High Top Straight Rod, 200mm; Savannah-T High Top Straight Rod, 220mm, Part Number 1705-220; Savannah-T High Top Straight Rod, 240mm, Product Code 10705-240; Savannah-T Straight Rod, 260mm, Part Number 10705-260; Savannah-T Straight Rod, 280mm, Part Number 10705-280; Savannah-T Straight Rod, 300mm, Part Number 10705-300; Savannah-T Notched Curved Rod, 200mm, Part Number 10706-200; Savannah-T Curve Rod, 200mm, Part Number 10707-200 The guide wire is passed through the cannulated handle of the Dual Stylet Needles and pressed into the bone
FDA Enforcement
Class II
·Terminated·Amendia, Inc·December 28, 2016
Achieva 1.5T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·November 29, 2023