iTotal® Hip Replacement System

FDA UDI

Conformis, Inc.·M572HDL060E30F011·HIP-IPOLY XE-LINER-GRP E (58-63) 40MM +0 FC

iTotal® Hip Replacement System

FDA UDI

Conformis, Inc.·M572HDL060D22F011·HIP-IPOLY XE-LINER-GRP D (54-57) 36MM +2 FC

iTotal® Hip Replacement System

FDA UDI

Conformis, Inc.·M572HDL060E32F011·HIP-IPOLY XE-LINER-GRP E (58-63) 40MM +2 FC

iTotal® Hip Replacement System

FDA UDI

Conformis, Inc.·M572HDL060B00F011·HIP-IPOLY XE-LINER-GRP B (46-49) 28MM +0 FC

iTotal® Hip Replacement System

FDA UDI

Conformis, Inc.·M572HDL060E22F011·HIP-IPOLY XE-LINER-GRP E (58-63) 36MM +2 FC

iTotal® Hip Replacement System

FDA UDI

Conformis, Inc.·M572HDL060F22F011·HIP-IPOLY XE-LINER-GRP F (64-66) 36MM +2 FC

iTotal® Hip Replacement System

FDA UDI

Conformis, Inc.·M572HDL060B12F011·HIP-IPOLY XE-LINER-GRP B (46-49) 32MM +2 FC

iTotal® Hip Replacement System

FDA UDI

Conformis, Inc.·M572HDL060F30F011·HIP-IPOLY XE-LINER-GRP F (64-66) 40MM +0 FC

iTotal® Hip Replacement System

FDA UDI

Conformis, Inc.·M572HDL060F32F011·HIP-IPOLY XE-LINER-GRP F (64-66) 40MM +2 FC

iTotal® Hip Replacement System

FDA UDI

Conformis, Inc.·M572HDL060C10F011·HIP-IPOLY XE-LINER-GRP C (50-53) 32MM +0 FC

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·LIAISON Murex Anti-HBc and LIAISON Murex Control Anti-HBc

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ELECSYS ANTI-HBC TEST SYSTEM

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ELECSYS ANTI-HBC TEST SYSTEM

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ELECSYS ANTI-HBC IGM TEST SYSTEM

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ELECSYS ANTI-HBC IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBC

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·IMMULITE, IMMULITE 1000 ANTI-HBC AND IMMULITE 2000 ANTI-HBC

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ELECSYS ANTI-HBC IGM IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBC IGM

MAKY 21.1 DIALYZER REPROCESSING SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

EXSEPT SKIN AND WOUND CLEANSER WITH ANTIMICROBIAL PRESERVATIVE

FDA 510(k)

FDA Class 2 ·General Hospital

PERACIDIN DIALYZER REPROCESSING CONCENTRATE

FDA 510(k)

FDA Class 2 ·General Hospital