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De Rigo Vision Spa

FDA registration
DE RIGO VISION S.P.A.·1 product·🇮🇹 Italy

STRYKER SPINE AVS ASL PEEK SPACER

FDA 510(k)
FDA Class 2 ·Orthopedic

SYNTHES ANGULAR STABLE LOCKING SYSTEM (ASLS)

FDA 510(k)
FDA Class 2 ·Orthopedic

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval
FDA Class 2 ·BBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval
FDA Class 2 ·BBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval
FDA Class 3 ·Belotero Balance(+) Lidocaine Dermal Filler (BBL)

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval
FDA Class 2 ·BBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval
FDA Class 2 ·BBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval
FDA Class 2 ·BBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval
FDA Class 2 ·BBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval
FDA Class 2 ·BBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC

aScope BronchoSampler™ 60 SC

FDA UDI
Ambu A/S·05707480156573·aScope BronchoSampler 60 SC / US

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG)

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval
FDA Class 3 ·Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG)

Quantum Blood and Fluid Warming System

FDA registration
CONTRACT MEDICAL MANUFACTURING, LLC·2 products·🇺🇸 United States

QUALITY IN FLOW LTD.

FDA registration
QUALITY IN FLOW LTD.·2 products·🇮🇱 Israel

ISOMEDIX OPERATIONS INC.

FDA registration
ISOMEDIX OPERATIONS INC.·2 products·🇺🇸 United States

M Warmer System

FDA registration
MEQU A/S·2 products·🇩🇰 Denmark

°MEQU

FDA registration
Bloodstone Division LLC·2 products·🇺🇸 United States

Warrior Extreme

FDA registration
SAFEGUARD US OPERATING, LLC·2 products·🇺🇸 United States