16 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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IMMUGLO ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY (ANCA) TEST SYTEM
FDA 510(k)
FDA Class 2
·Immunology
AMEDICA DRUG SCREEN TEST CUP
FDA 510(k)
FDA Class 2
·Clinical Toxicology
TenoTac Soft Tissue Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
TROCHANTERIC NAIL KIT, TI GAMMA3 11X200MM X 125
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·November 7, 2012
CADD LEGACY PUMP
FDA Adverse Event
Malfunction
·ST PAUL·Product code FRN·April 11, 2022
CADD LEGACY PLUS PUMP
FDA Adverse Event
Malfunction
·ST PAUL·Product code FRN·September 8, 2022
CADD LEGACY PLUS PUMP
FDA Adverse Event
Malfunction
·ST PAUL·Product code FRN·September 23, 2022
CADD LEGACY PLUS PUMP
FDA Adverse Event
Malfunction
·ST PAUL·Product code FRN·September 22, 2022
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·February 28, 2013
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP·Product code CBK·July 2, 2014
ARCHITECT STAT TROPONIN-I
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES·Product code MMI·February 9, 2011
CADD LEGACY PLUS PUMP
FDA Adverse Event
Malfunction
·ST PAUL·Product code FRN·September 22, 2022
CADD LEGACY PLUS PUMP
FDA Adverse Event
Malfunction
·ST PAUL·Product code FRN·September 8, 2022
CADD LEGACY PLUS PUMPS
FDA Adverse Event
Malfunction
·ST PAUL·Product code FRN·October 29, 2022
CADD LEGACY PLUS PUMPS
FDA Adverse Event
Malfunction
·ST PAUL·Product code FRN·October 24, 2022
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024