26 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix Anterior Cervical Plate System, Spinema Lumbar Plate System
FDA 510(k)
FDA Class 2
·Orthopedic
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772777525·LUMBAMED PLUS FLEX PAD M SILVER V
Restore
FDA UDI
KEYSTONE DENTAL, INC.·D768L21003519K0·Hex Driver
NA
FDA UDI
Biedermann Motech GmbH & Co. KG·04250869604048·MOSS Ti Rod, Ø5.5x35mm curved
NA
FDA UDI
Biedermann Motech GmbH & Co. KG·04250869609111·MOSS VRS Ti rod, Ø5.5x35mm, curved
Restore
FDA UDI
KEYSTONE DENTAL, INC.·D768L21003524K0·Hex Driver
Admiral
FDA UDI
Seaspine Orthopedics Corporation·10889981278151·Cervical Plate, 2 Level, 35mm
Salvo® Spine System
FDA UDI
Spine Wave, Inc.·10840642174373·8.5 x 50 mm Bone Screw, Cannulated, 3 mm Pitch
EXPLOR
FDA UDI
Biomet Orthopedics, LLC·00880304210417·
Stimulator, Bone Growth, Non-Invasive
FDA Pre-Market Approval
FDA Class 2
·AccelStimTM Bone Growth Stimulator
INDIKO
FDA 510(k)
FDA Class 1
·Clinical Chemistry
IVS TUNNELLER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
RIVA Posterior Fixation System
FDA UDI
XENIX MEDICAL LLC·00840493415505·Open Lateral Connector, 35mm
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 22, 2024
Stimulator, Bone Growth, Non-Invasive
FDA Pre-Market Approval
FDA Class 2
·AccelStim
Stimulator, Bone Growth, Non-Invasive
FDA Pre-Market Approval
FDA Class 2
·AccelStim
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·May 16, 2016
REDITEST ON-SITE ORAL FLUID DRUG SCREEN DEVICE
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC·Product code MVO·June 21, 2013
VRPT PLUS RPF 10MM-15MM TRC W/100MM SLV
FDA Adverse Event
Malfunction
·PONCE-USS·Product code GCJ·October 21, 2008
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS·Product code NKB·August 12, 2011