17 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Atteris No-Sting Skin Protectant
FDA 510(k)
FDA Class 1
·General Hospital
ADPER PROMPT, ADPER PROMPT L-POP
FDA 510(k)
FDA Class 2
·Dental
CELLTRACKS AUTOPREP SYSTEM MODEL:9541
FDA 510(k)
FDA Class 1
·Hematology
OXFORD PARTIAL KNEE SYSTEM ANATOMIC MENISCAL BEARING MEDIUM LEFT 5MM THICK
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code NRA·February 24, 2017
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
RESERVOIR 3ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·June 10, 2013
MICRO SAGITTAL SAW
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code HBE·June 30, 2011
HARMONIC ACE 23CM W ERG HANDLE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC·Product code LFL·September 5, 2008
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
ADVANCED PATELLA 35MM 3 PEG IMPLANT
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·January 9, 2024
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024