12 results
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19ms
·
Sources: EU EUDAMED, US FDA
CORDIS AVANTI CATHETER SHEATH INTRODUCER
FDA 510(k)
FDA Class 2
·Cardiovascular
Electrode for ABL analyzers
FDA UDI
Radiometer Medical ApS·05700699456168·E733 Ca electrode for ABL7XX/8XX
SALIVA EJECTOR DISPOSABLE
FDA 510(k)
FDA Class 1
·Dental
URIHESIVE STRIP
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
TARGET DEVICE GAMMA3 300X160MM
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·November 13, 2012
PELVIC ARRAY ASSY
FDA Adverse Event
Malfunction
·MAKO SURGICAL CORP.·Product code OLO·February 14, 2018
PELVIC ARRAY ASSY
FDA Adverse Event
Malfunction
·MAKO SURGICAL CORP.·Product code OLO·February 21, 2018
PELVIC ARRAY ASSY
FDA Adverse Event
Malfunction
·MAKO SURGICAL CORP.·Product code OLO·October 30, 2018
PROFEMUR(R) Z STEM
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code LPH·February 6, 2013
ASR ACETABULAR CUPS 50
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·December 30, 2010
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·July 21, 2014
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