10 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TUTTNAUER ELECTRONIC AUTOCLAVE, MODELS E, EA, EK, EKA, EP
FDA 510(k)
FDA Class 2
·General Hospital
WET-NO-MORE MONITOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ABUSCREEN ONTRAK POS. REF. CONTROL FOR MORPHINE
FDA 510(k)
FDA Class 1
·Clinical Toxicology
US NANCY NAIL 450 20/10
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code HSB·July 26, 2016
ISOLATOR SYNERGY
FDA Adverse Event
Injury
·ATRICURE, INC.·Product code GEI·March 4, 2013
PULSE GEN MODEL 103
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·February 11, 2011
MAXIMO VR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·August 8, 2014
US NANCY NAIL 450 25/10
FDA Adverse Event
Injury
·BIOMET TRAUMA·Product code HSB·June 1, 2017
General Pack, part number AMS2967(A General Pack, part number AMS3239(A General Pack, part number AMS3709(B General Pack, part number AMS5341 General Pack, part number AMS5694
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024