11 results
·
19ms
·
Sources: EU EUDAMED, US FDA
BIOMESH BIODEGRADABLE GTR BARRIER
FDA 510(k)
FDA Class 2
·Dental
Omnia Medical TiBrid Cervical Cage, Omnia Medical TiBrid Lateral Cage, Omnia Medical TiBrid ALIF Cage, Omnia Medical TiBrid PLIF Cage, Omnia Medical TiBrid TLIF Cage
FDA 510(k)
FDA Class 2
·Orthopedic
ZIO PATCH, MODEL Z100
FDA 510(k)
FDA Class 2
·Cardiovascular
ULTRACISION SURG DEV, BLADES 10MM REUSABLE, OPEN
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code KNS·June 7, 2006
ULTRACISION SURG DEV, BLADES 10MM REUSABLE, OPEN
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code KNS·June 7, 2006
ULTRACISION SURG DEV, BLADES 10MM REUSABLE, OPEN
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code KNS·June 7, 2006
ULTRACISION SURG DEV, BLADES 10MM REUSABLE, OPEN
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code GEO·June 19, 2006
ASR UNI FEMORAL IMPL SIZE 51
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·March 5, 2013
ADAPTA DR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL, INC.·Product code NVZ·February 15, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·August 7, 2014
Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/126/030 100/126/035 100/127/025 100/127/030 100/127/035 100/141/025 100/141/030 100/141/035
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD, Inc.·March 19, 2025