PROW FUSION-L

FDA 510(k)

FDA Class 2 ·Orthopedic

SIGMA ELITE

FDA 510(k)

FDA Class 2 ·Anesthesiology

TiLink-P Joint Fusion System

FDA 510(k)

FDA Class 2 ·Orthopedic

PROW FUSION

FDA 510(k)

FDA Class 2 ·Orthopedic

PROW FUSION-V

FDA 510(k)

FDA Class 2 ·Orthopedic

Synxess Neurovascular Guidewire

FDA 510(k)

FDA Class 2 ·Cardiovascular

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

FDA Pre-Market Approval

FDA Class 3 ·DIASORIN ETI-AB-EBK PLUS ASSAY

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

FDA Pre-Market Approval

FDA Class 3 ·DIASORIN ETI-EBK PLUS ASSAY

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·DIASORIN ETI-AB-HAVK PLUS ASSAY

BASIC, MODELS BASIC 1, BASIC 2, AND BASIC 3

FDA 510(k)

FDA Class 2 ·Radiology

EXMOOR AURAL GROMMET AG/TI

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

cobas® PCR Urine Sample Kit

FDA UDI

Roche Molecular Systems, Inc.·00875197002898·

APTIMA

FDA UDI

Hologic, Inc.·15420045506244·

Xpert Urine Specimen Collection Kit

FDA UDI

CEPHEID·07332940002954·Xpert Urine Specimen Collection Kit; 50 pack

Visby Medical Sexual Health Click Test

FDA UDI

Visby Medical, Inc.·00810031720002·Visby Medical Sexual Health Click Test

Gonochek®-II Reagent Tubes

FDA UDI

E-Y Laboratories, Inc.·00863251000218·Gonochek®-II is intended for the use in the det...

Visby Medical Sexual Health Vaginal Specimen Collection Kit, 50 Pack

FDA UDI

Visby Medical, Inc.·00810031720057·Visby Medical Sexual Health Vaginal Specimen Co...

BD ProbeTec™ Urine Preservative Transport

FDA UDI

BECTON, DICKINSON AND COMPANY·30382904409280·Tube Urine Preservation Transport

Urine Preservative Transport for the BD ProbeTec™ Qx Amplified DNA Assays

FDA UDI

BECTON, DICKINSON AND COMPANY·30382904413621·Urine Preservative Transport for the BD ProbeTe...

Aptima®

FDA UDI

Hologic, Inc.·15420045511880·Aptima® Specimen Transfer Kit, 100 test.