14 results
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27ms
·
Sources: EU EUDAMED, US FDA
LEAD, TINED PACING, IMPLANTABLE
FDA 510(k)
FDA Class 3
·Cardiovascular
Helix
FDA UDI
Nuvasive, Inc.·00887517136015·Helix R Plate, 54mm 3-Level
MGB Alert HSV 1&2 Typer Primer Mix ASR - 480 rxn
FDA UDI
Elitechgroup Mdx LLC·03661540951381·MGB Alert® HSV 1 & 2 Primer Mix contains chemic...
0800,APS0,08,N,L1,L2,VL
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828152808·0800,APS0,08,N,L1,L2,VL
Elite Orthopaedics
FDA UDI
Elite Orthopaedics, Inc.·00816591014001·OA Knee Brace, Single Upright, Left
Elite Orthopaedics
FDA UDI
Elite Orthopaedics, Inc.·00816591013998·OA Knee Brace, Single Upright, Right
C.T.M. MOBILITY SCOOTERS HS-666, HS-730, HS-570
FDA 510(k)
FDA Class 2
·Physical Medicine
PRIMAL OK INTERSPINOUS FUSION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
PROMUS PREMIER?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·May 8, 2014
HEARTMATE II LVAS
FDA Adverse Event
Death
·THORATEC CORP.·Product code DSQ·October 18, 2012
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 28, 2007
Cardima Surgical Ablation Probe (SAP) Electrosurgical cutting and coagulation device, Model Number 01-242208, manufactured by Cardima Inc, Fremont, CA
FDA Recall
Terminated
·Cardima Inc·Product code OCL·May 20, 2010
Cardima Surgical Ablation Probe (SAP) Electrosurgical cutting and coagulation device, Model Number 01-242208, manufactured by Cardima Inc, Fremont, CA
FDA Recall
Terminated
·Cardima Inc·Product code OCL·May 20, 2010
Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018