26 results · 20ms · Sources: EU EUDAMED, US FDA

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FDA Pre-Market Approval
CEEON HEPARIN SURFACE MODIFIED (ASM) ULTRAVIOLET LIGHT.

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·CEEON HEPARIN SURFACE MODIFIED (HSM) UV LIGHT-ABSORBING POSTERIOR CHAMBER IOLS

FDA Pre-Market Approval
POLYMETHYLMETHACRYLATE(PMMA) POSTERIOR CHAMBER INTRAOCULAR LENSES

X-CORE

FDA UDI
Nuvasive, Inc.·00887517267795·X-CORE Mini Lock Screw, Ø14mm

LEONE SPA

FDA UDI
LEONE SPA·08033707086833·BANDE ANATOMICHE SMILE I MOL LR 34

Matching Limb Protection Sleeves - Easi-Fit BFR

FDA UDI
Delfi Medical Innovations Inc·M995979600341·Delfi Matching Limb Protection Sleeves (MLPS) h...

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·Powerheart® AED G3 Pro

Qualitative And Quantitative Hepatitis B Virus Antibody Assays

FDA Pre-Market Approval
FDA Class 2 ·BIO RAD MONOLISA ANTI-HBC IGM EIA

LXN BLOOD GLUCOSE TEST SYSTEM

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

APEXPLUS

FDA Adverse Event
Other ·SUMMIT TECHNOLOGY·Product code LZS·March 16, 2001

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

FDA Pre-Market Approval
FDA Class 2 ·MONOLISA ANTI-HBC IGM EIA

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

FDA Pre-Market Approval
FDA Class 2 ·BIO-RAD MONOLISA ANTI-HBC IGM EIA

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

FDA Pre-Market Approval
FDA Class 2 ·BIO-RAD MONOLISA ANTI-HBC IGM EIA

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

FDA Pre-Market Approval
FDA Class 2 ·BIO-RAD MONOLISA ANTI-HBC IGM EIA

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·Powerheart® G3 Pro AED

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

FDA Pre-Market Approval
FDA Class 2 ·BIO-RAD MONOLISA ANTI-HBC IGM EIA

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

FDA Pre-Market Approval
FDA Class 2 ·MONOLISA ANTI-HBC IGM EIA

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

FDA Pre-Market Approval
FDA Class 2 ·BIO-RAD MONOLISA ANTI-HBC IGM EIA

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval
FDA Class 3 ·Powerheart G3 Pro Automated External Defibrillator

SYNCHROMED II

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·May 24, 2019