276 results · 34ms · Sources: EU EUDAMED, US FDA

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Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·BJORK-SHILEY CARDIAC VALVE

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·BJORK-SHILEY CARDIAC VALVE

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·BJORK-SHILEY CARDIAC VALVE

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·BJORK-SHILEY CARDIAC VALVE

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·BJORK-SHILEY CARDIAC VALVE

Heart-Valve, Mechanical

FDA Pre-Market Approval
FDA Class 3 ·BJORK-SHILEY CARDIAC VALVE

Axcent Acrylics

FDA UDI
GARRECO, LLC·D79337800080·ACR MON #1 HC (8 OZ EACH)

Triad

FDA UDI
Nuvasive, Inc.·00887517265012·Triad Cervical Rasp, 8x11x11mm

Washbon

FDA UDI
ORMCO CORPORATION·00889989043693·UPPER LEFT FIRST MOLAR WASHBON BAND SIZE 8

ANIMAS VIBE

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code OYC·January 12, 2017

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval
FDA Class 3 ·VIDAS FREE PSA RT ASSAY

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval
FDA Class 3 ·t:slim X2 Insulin Pump with Basal-IQ Technology

GOAT ANTI-INFLUENZA ANTISERA

FDA 510(k)
FDA Class 1 ·Microbiology

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval
FDA Class 3 ·VIDAS FREE PSA RT

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval
FDA Class 3 ·t:slim X2 Insulin Pump with Basal-IQ Technology

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval
FDA Class 3 ·t:slim X2 Insulin Pump with Basal-IQ Technology

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval
FDA Class 3 ·VIDAS FREE PSA (FPSA) ASSAY

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval
FDA Class 3 ·t:slim X2 Insulin Pump with Basal-IQ Technology

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval
FDA Class 3 ·t:slim X2 Insulin Pump with Basal-IQ Technology

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval
FDA Class 3 ·t:slim X2 Insulin Pump with Basal-IQ Technology