2,666 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Ambler Surgical
FDA UDI
AMBLER SURGICAL CORP.·00190660205119·Protective cover for intraocular forceps/scissors
OWREN'S VERONAL BUFFER
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH·Product code KQJ·September 14, 2021
BIOPROTECT BALLOON IMPLANT SYSTEM OVB
FDA Adverse Event
Injury
·BIOPROTECT LTD.·Product code OVB·July 4, 2024
INNOVANCE D-DIMER
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH·Product code DAP·June 3, 2021
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·May 31, 2012
SpaceOAR Vue System, UPN SV-1010 and SV-2101. Used to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer to reduce the radiation dose delivered to the anterior rectum.
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code OVB·February 24, 2022
SpaceOAR System, UPN SO-1010, SO-2101, SO-3101, and SO-4101. Used to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer to reduce the radiation dose delivered to the anterior rectum.
FDA Recall
Open, Classified
·Boston Scientific Corporation·Product code OVB·February 24, 2022
SPACEOAR SYSTEM
FDA Adverse Event
Injury
·AUGMENIX, INC·Product code OVB·December 21, 2016
SPACEOAR SYSTEM
FDA Adverse Event
Injury
·AUGMENIX, INC·Product code OVB·December 16, 2016
SPACEOAR SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OVB·April 30, 2021
SPACEOAR VUE SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OVB·April 16, 2021
SPACEOAR SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OVB·June 18, 2021
SPACEOAR SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code OVB·June 14, 2021
SPACEOAR SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code OVB·April 19, 2021
SPACEOAR SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code OVB·June 1, 2021
SPACEOAR VUE SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code OVB·June 1, 2021
SPACEOAR SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OVB·May 18, 2021
SPACEOAR VUE SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OVB·June 8, 2021
SPACEOAR VUE SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OVB·May 14, 2021
SPACEOAR VUE SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code OVB·June 21, 2021