14 results
·
28ms
·
Sources: EU EUDAMED, US FDA
LEUKOPOR SURGICAL TAPE
FDA 510(k)
FDA Class 1
·General Hospital
UNKNOWN BUR
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code EQJ·November 4, 2020
UNKNOWN BUR
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code EQJ·November 4, 2020
UNKNOWN BUR
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code EQJ·November 4, 2020
UNKNOWN BUR
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code EQJ·November 4, 2020
BERKELEY BRAKE
FDA 510(k)
FDA Class 1
·Physical Medicine
FX CorAL 60 (F00012969); FX CorAL 80 (F00012970); FX CorAL 100 (F00012971); FX CorAL 120 (F00012972); FX CorAL 600 (F00012973); FX CorAL 800 (F00012974); FX CorAL 1000 (F00012975)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
XPS® BUR - UNKNOWN
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code EQJ·March 9, 2017
DRILL 3055601 SKEETER OTO-TOOL
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC·Product code ERL·January 11, 2013
XPS® BUR - UNKNOWN
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code EQJ·March 8, 2017
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·June 2, 2014
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·October 26, 2012
PROXIMATE*ILS CURVED CIR STAPL
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·September 24, 2010
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024