132 results
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27ms
·
Sources: EU EUDAMED, US FDA
CARESIDE CREATININE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DeltaForm HD
FDA UDI
Merz Dental GmbH·D7091980043·DeltaForm HD lower posteriors, L, A4 -MADE IN G...
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756047982·ST BIAS STOCKINETTE
ESIS MODULE
FDA 510(k)
FDA Class 2
·Cardiovascular
VIZILITE EYEWEAR
FDA 510(k)
FDA Class 2
·Dental
ANSPACH***REF 98-0043***Custom Device eMax 2 Plus Hand Control that will work with a Speed Reducer***Rx Only*** This device is intended to be used with Anspach Systems
FDA Enforcement
Class II
·Terminated·The Anspach Effort, Inc.·July 2, 2014
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·HANCOCK II PORCINE BIOPROSTHESIS
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 5, 2014
LAMITRODE TRIPOLE 16
FDA Adverse Event
Injury
·ST JUDE MEDICAL - NEUROMODULATION·Product code LGW·February 22, 2013
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·January 24, 2011
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·HANCOCK II BIOPROSTHESIS, MODELS T505 AND T510
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·Hancock II and Hancock Ultra II Bioprosthesis
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·HANCOCK II PORCINE BIOPROSTHESIS
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·HANCOCK II PORCINE BIOPROSTHESIS
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·HANCOCK II PORCINE BIOPROSTHESIS
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·HANCOCK II PORCINE BIOPROSTHESIS- (MODELS T505, T510)
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·Hancock II Bioprosthesis, Models T505, T510
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·HANCOCK II PORCINE BIOPROSTHESIS
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·HANCOCK II PORCINE BIOPROSTHESIS
Replacement Heart-Valve
FDA Pre-Market Approval
FDA Class 3
·Hancock II Bioprosthesis