9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Best Instruminal Applicator
FDA 510(k)
FDA Class 2
·Radiology
DUOFERTILITY
FDA 510(k)
FDA Unclassified
·Unknown
BIOMERIX COMPOSITE SURGICAL MESH
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VITEK MASS SPECTROMETER
FDA Adverse Event
Malfunction
·BIOMERIEUX, SA·Product code PEX·October 12, 2017
POWER TOOTHBRUSH REPLACEMENT HEAD
FDA Adverse Event
Malfunction
·RANIR LLC·Product code JEQ·June 6, 2013
COGNIS
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·July 14, 2011
CAPSUREFIX MRI SURESCAN
FDA Adverse Event
Injury
·MPRI·Product code NVN·October 10, 2014
REF 623421 L S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Left , X-Small, Sterile R Qty 1 The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone loss or ligament instability and additional support is needed. S-Rom femorals and inserts are brought into nearly every revision case as backup should the MCL become compromised during the procedure. If additional constraint is required the surgeon can use the S-ROM femoral and insert. S-ROM femorals are used in less than 10% of knee revision procedures, but are present almost all the time.
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·March 19, 2014
REF 623421 RS-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Right , X-Small, Sterile R Qty 1 The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone loss or ligament instability and additional support is needed. S-Rom femorals and inserts are brought into nearly every revision case as backup should the MCL become compromised during the procedure. If additional constraint is required the surgeon can use the S-ROM femoral and insert. S-ROM femorals are used in less than 10% of knee revision procedures, but are present almost all the time.
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·March 19, 2014