DELTON F PIT & FISSURE SEALANT

FDA 510(k)

FDA Class 2 ·Dental

TRUBYTE DENTURE BOND DENTURE BONDING AGENT

FDA 510(k)

FDA Class 2 ·Dental

SUREFLEX FILES

FDA 510(k)

FDA Class 1 ·Dental

PATIENT EXAMINATION GLOVES (LATEX)

FDA 510(k)

FDA Class 1 ·General Hospital

CK-NAC 2-VIAL REAGENT W/SUBSTRATE START

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TOTAL ETCH GEL

FDA 510(k)

FDA Class 2 ·Dental

DYRACT II RESTORATIVE

FDA 510(k)

FDA Class 2 ·Dental

ENTERSCAN

FDA 510(k)

FDA Class 2 ·Radiology

ALT (GPT) IFCC 2-VIAL REAGENT W/PYRIDOXYL PHOSPHAT

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

DYRACT(TM) MATERIAL

FDA 510(k)

FDA Class 2 ·Dental

HDL CHOLESTEROL KIT

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

SPECTRUM CURING LIGHT POLYMERIZATION UNIT

FDA 510(k)

FDA Class 2 ·Dental

PRIME & BOND DIRECT COMPOSITE BONDING AGENT

FDA 510(k)

FDA Class 2 ·Dental

Anti-Kpb Blood Grouping Reagent

Basic UDI-DI

EU IVDR · Eu Ivd Class C ·Immucor, Inc.·1 device

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Restore, Intellis™, Vanta™ and Inceptiv™ Spinal Cord Stimulation Systems, Pisces™, Specify®, and Vectris® Spinal Cord St

Lipoprotein, Low Density, Removal

FDA Pre-Market Approval

FDA Class 3 ·LIPOSORBER(R) LA-15 SYSTEM ADSORPTION COLUMN, SULFUX(R) FS-05 PLASMA SEPARATOR, AND TUB. SYST. FOR PLASMAPHER. (LT-MA2).

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·InterStim® Therapy System, Verify® Evaluation System

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·InterStim® Therapy System, Verify® Evaluation System

Anti-Kpb, Coombs-reactive, polyclonal, human

Basic UDI-DI

EU IVDR · Eu Ivd Class C ·ANTITOXIN GmbH·1 device