PARALLAX ACRYLIC RESIN CARTRIDGE WITH TRACERS-TA

FDA 510(k)

FDA Class 2 ·Orthopedic

MODIFICATION TO ARTHROCARE ARTHROWANDS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

GLOVETEX LATEX EXAMINATION GLOVES, POWDERED, BLUE, NON STERILE

FDA 510(k)

FDA Class 1 ·General Hospital

ARTHROCARE ENT COBLATOR SURGERY SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

STERILE POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CLAIM LESS THAN 50U/G OF GLOVES

FDA 510(k)

FDA Class 1 ·General Hospital

Non-sterile, Powder Free Nitrile Examination Gloves

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Innolatex (Thailand) Limited·5 devices

LC-04R-N

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·Zenith Lab (Jiangsu) Co.,Ltd·1 device

Ethyl Glucuronide (ETG) Test Dip Card 500 (Colloidal Gold)

Basic UDI-DI

EU IVDD · Eu Ivd General ·Shenzhen Superbio Technology Co.,Ltd.·1 device

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

FDA Pre-Market Approval

FDA Class 3 ·ELECSYS FREE PSA

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

FDA Pre-Market Approval

FDA Class 3 ·DIMENSION FPSA FLEX REAGENT CARTRIDGE

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

FDA Pre-Market Approval

FDA Class 3 ·Dimension Vista FPSA Flex reagent cartridge (K6452)

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

FDA Pre-Market Approval

FDA Class 3 ·ABBOTT AXSYM FREE PSA ASSAY

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

FDA Pre-Market Approval

FDA Class 3 ·ABBOTT IMX FREE PSA

Paste, Injectable For Vocal Cord Augmentation

FDA Pre-Market Approval

FDA Class 3 ·MENTOR POLYTEF PASTE /FOR INJECTION

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

FDA Pre-Market Approval

FDA Class 3 ·ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS

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

FDA Pre-Market Approval

FDA Class 3 ·Dimension FPSA Flex Reagent Cartridge

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

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

FDA Pre-Market Approval

FDA Class 3 ·ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS

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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT FREE PSA

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

FDA Pre-Market Approval

FDA Class 3 ·DIMENSION FPSA FLEX REAGENT CARTRIDGE AND DIMENSION VISTA FPSA FLEX REAGENT CARTRIDGE