DATALOGGER CHART RECORDER

FDA 510(k)

FDA Class 1 ·Cardiovascular

SPECTRA FLUORESCENCE CARIES DETECTION DEVICE

FDA 510(k)

FDA Class 2 ·Dental

AMBU UNIVERSAL SUCTION PUMP

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Intelli-Ox

FDA 510(k)

FDA Class 1 ·Anesthesiology

VACSTAR

FDA 510(k)

FDA Class 1 ·Dental

SCANX D5000 SERIES SCANNER MODEL: D5000-F, D5000-FB, D5000-FVB, D5000-Q, D5000-QB

FDA 510(k)

FDA Class 2 ·Radiology

MODELS C500/C550 ISOLETE(R) INFANT INCUBATOR

FDA 510(k)

FDA Class 2 ·General Hospital

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·Juvéderm Ultra, Juvéderm Ultra XC, Juvéderm Ultra Plus XC

Stimulator, Invasive Bone Growth

FDA Pre-Market Approval

FDA Class 3 ·SpF Implantable Spinal Fusion Stimulators

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·Juvéderm Voluma XC, Vollure XC, Volbella XC, Volux XC, Skinvive

Stimulator, Invasive Bone Growth

FDA Pre-Market Approval

FDA Class 3 ·EBI OsteoGen Impantable Bone Growth Stimulators

DEKA PHYSIQ

FDA UDI

EL.EN. SPA·08057017760498·The PHYSIQ is a system provided with 4 IR LED t...

Fluid, Intraocular

FDA Pre-Market Approval

FDA Class 3 ·VITREON INTRAOCULAR FLUID (PERFLUOROPERHYDROPHENANTHRENE)

Fluid, Intraocular

FDA Pre-Market Approval

FDA Class 3 ·VITREON(R)

Sealant, Polymerizing

FDA Pre-Market Approval

FDA Class 3 ·NEOMEND PROGEL PLEURAL AIR LEAK SEALANT

Sealant, Polymerizing

FDA Pre-Market Approval

FDA Class 3 ·NEOMEND PROGEL PLEURAL AIR LEAK SEALANT

Sealant, Polymerizing

FDA Pre-Market Approval

FDA Class 3 ·PROGEL PLEURAL AIR LEAK SEALANT DEVICE

Sealant, Polymerizing

FDA Pre-Market Approval

FDA Class 3 ·NEOMEND PROGEL PLEURAL AIR LEAK SEALANT

Sealant, Polymerizing

FDA Pre-Market Approval

FDA Class 3 ·NEOMEND PROGEL PLEURAL AIR LEAK SEALANT

Sealant, Polymerizing

FDA Pre-Market Approval

FDA Class 3 ·PROGEL Pleural Air Leak Sealant (PALS)