BioGlide®

FDA UDI

MEDTRONIC PS MEDICAL, INC.·00643169472570·CATH 27705 EDM NUM LNGTHMARK BIO 35CM

CAMINO®

FDA UDI

NATUS MEDICAL INCORPORATED·00382830047500·INTRACRANIAL PRESSURE-TEMPERATURE MONITORING KIT

Integra® Jarit®

FDA UDI

INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780152729·STILLE PATTERN CRANIAL DRILL SET

Integra®

FDA UDI

INTEGRA PAIN MANAGEMENT·10381780431954·Integra® Lumbar Prep Tray

Licox®

FDA UDI

GMS, Gesellschaft für medizinische Sondentechnik mbH·10381780041061·Licox® Oxygen Probe

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·RADIESSE

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·RADIESSE

ADDED USE CLAIM FOR DUPONT ACA BETA-2-MICROGLOBULIN TEST PACK

FDA 510(k)

FDA Class 2 ·Immunology

DUPONT ACA PLUS IMMUNOASSAY SYSTEM FOLLICLE STIMULATING HORMONE

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

DUPONT ACA PLUS PROLACTIN (PROL) METHOD

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

DUPONT CRONEX PORTABLE GRID CASSETTE

FDA 510(k)

FDA Class 2 ·Radiology

DUPONT DIMENSION TOTAL PROTEIN METHOD

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CREATINE KINASE METHOD

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

URINARY ALBUMIN TEST PACK

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

CRONEX REGULAR CASSETTE

FDA 510(k)

FDA Class 2 ·Radiology

DUPONT ACA PLUS THYROID STIMULATING HORMONE SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DUPONT ACA PLUS FSH/LH/PROLACTIN CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ACA(R) DIGOXIN ANALYTICAL TEST PACK (DGN)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

BioStamp nPoint™

FDA UDI

Medidata Solutions, Inc.·G012BRCP01·Mobile application phone

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·Alinity m CMV Assay