14 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TITANIUM DYNA-LOK SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SALVATION(R) External Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
MODIFICATION TO RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
D901 LILLIPUT OXYGENATOR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTZ·October 13, 2021
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
FDA Adverse Event
Malfunction
·MEDTRONIC MILACA, INC.·Product code LWP·February 9, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 23, 2014
VENTAK PRIZM
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·January 10, 2011
CUSTOM PERFUSION PACK
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTZ·October 30, 2012
LILLIPUT 1 START
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·April 17, 2023
LILLIPUT 1 OXYGENATOR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALY·Product code DTZ·December 27, 2024
LILLIPUT 1 NEW BORN HOLLOW FIBER OXYGENATOR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTZ·December 6, 2024
LILLIPUT 1 NEW BORN HOLLOW FIBER OXYGENATOR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·January 17, 2022
LILLIPUT 1 NEW BORN HOLLOW FIBER OXYGENATOR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA SRL·Product code DTZ·January 25, 2022
Acumatch L-Series BIPOLAR LINER, 22mm (BIPOLAR ENDOPROSTHESIS-Hip), Item Numbers: a) 100-22-19, SZ. L; b) 100-22-20, SZ. M; c) 100-22-21, SZ. N; d) 100-22-22, SZ. P; e) 100-22-23, SZ. R; f) 100-22-24, SZ. S; g) 100-22-25, SZ. T
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·July 10, 2024