Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENDOTAK RELIANCE FAMILY OF LEADS

SureStepTM Urine Test Drug Screen Strip, Benzodiazepines (BZO 300)

FDA UDI

ALERE SAN DIEGO, INC.·00810124273026·

CERTUM BZO One Step Benzodiazepines Test Strip

FDA UDI

ALERE SAN DIEGO, INC.·00810124273729·

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Drug-Eluting Permanent Defibrillator Electrodes

SLT MULTIDIMENSIONAL CONTACT LASER SYSTEM & WCE DIFFUSER FLAT PROBE DF 2

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Protego SD 60/16, Protego SD 65/16, Protego SD 65/18, Protego SD 75/18, Protego TD 65/16, Protego TD 65/18, Protego TD 7

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·PROMOTE, QUADRA ASSURA, UNIFY, UNIFY ASSURA, UNIFY QUADRA FAMILES OF CRT-D DEVICES

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CURRENT, ELLIPSE, FORTIFY, FORTIFY ASSURA FAMILIES OF ICD DEVICES

FERRITIN IMMUNORADIOMETRIC ASSAY KIT

FDA 510(k)

FDA Class 2 ·Immunology

RANDOX MICROALBUMIN

FDA 510(k)

FDA Class 2 ·Immunology

MICROALBUMIN TIA REAGENT; MALB CALIBRATOR SET 200; MALB CONTROL-L, CONTROL-H

FDA 510(k)

FDA Class 2 ·Immunology

FLUORESCEIN CONJUGATED IMMUNOGLOBIN-

FDA 510(k)

FDA Class 2 ·Immunology

MICROALBUMIN REAGENT SET AND CALIBRATORS

FDA 510(k)

FDA Class 2 ·Immunology

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Permanent Defibrillator Electrodes: Protego SD, Protego TD, Protego S and Protego T

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Defibrillator, Implantable Cardioverter, with Cardiac Resynchronization (Crt-D); Defibrillator, Implantable, Dual-Chambe

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Ilesto 7 VR-T, Iforia 7 VR-T, Ilesto 5 VR-T, Iforia 5 VR-T, Inventra 7 VR-T, Iperia 7 VR-T, Itrevia 7 VR-T, Iperia 5 VR-

MALLORY/HEAD TOTAL HIP SYSTEM; HA MALLORY/HEAD TOTAL HIP SYSTEM; BI-METRIC FEMORAL COMPONENTS

FDA registration

Biomet Mexico·2 products·🇲🇽 Mexico

RESORBABLE INTERFERENCE SCREW

FDA registration

BIOMET CHILE S.A.·1 product·🇨🇱 Chile

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FDA registration

BIOMET CHILE S.A.·1 product·🇨🇱 Chile