10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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QuantaFlo
FDA 510(k)
FDA Class 2
·Cardiovascular
MAXIM VI KNEE SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304205680·
MAXIM® VI KNEE SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00887868225758·
CABLE,XDUCER,IBP,EDWARD,6PIN
FDA UDI
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06944904003894·
EASYSPINE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT / OXIMETRY MONITOR; VIGILEO APCO / OXIMETRY MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
POLYSORB 2/0 30 UNDYED HOS-11
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY US SUR·Product code GAM·May 24, 2013
KANGAROO EPUMP
FDA Adverse Event
Malfunction
·COVIDIEN·Product code LZH·September 25, 2014
ON-Q, 400ML, 2-14ML/HR SAF, PUMP
FDA Adverse Event
Injury
·I-FLOW CORP.·Product code MEB·June 23, 2011
CRANIOSCULPT C, 10CC. Product Number: C-C10CC, UDI: 813845021129 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.
FDA Enforcement
Class II
·Terminated·Skeletal Kinetics, Llc·July 22, 2020