I.S.M. PRODUCT FAMILY MODEL P2400C,A & ABC

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ABC CAUDAL AND CRANIAL EXTENSION PLATE (E-PLATE)

FDA 510(k)

FDA Class 2 ·Orthopedic

THERMOGARD DISPERSIVE ELECTRODES, THERMOGARD PLUS ABC DISPERSIVE ELECTRODES

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BEND-A-BEAM HAND CONTROL MALLEABLE ABC HANDPIECE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CARTRIDGE, AND LOCI THYROID CALIBRATOR, MOD

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION VISTA CREATININE (CRE2) FLEX REAGENT CARTRIDGE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

OT EQUATOR

FDA 510(k)

FDA Class 2 ·Dental

restor3d Kinos Axiom Total Ankle System

FDA 510(k)

FDA Class 2 ·Orthopedic

Kinos Axiom Total Ankle System

FDA 510(k)

FDA Class 2 ·Orthopedic

DIMENSION VISTA SYSTEM IGG FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA SYST

FDA 510(k)

FDA Class 2 ·Immunology

DIMENSION VISTA DIGITOXIN CALIBRATOR - DGTX CAL

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION VISTA SYSTEM LIPID CALIBRATOR, MODEL KC220

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION VISTA SYSTEM ENZYME2 CALIBRATOR, MODEL KC320

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, DIMENSION VISTA SYSYEM

FDA 510(k)

FDA Class 2 ·Immunology

PT-MULTI-CALIBRATOR, MODEL OPAT07

FDA 510(k)

FDA Class 2 ·Hematology

OT EQUATOR

FDA 510(k)

FDA Class 2 ·Dental

restor3d TIDAL Lumbar Interbody Fusion System

FDA 510(k)

FDA Class 2 ·Orthopedic

Uresta®

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

EASY-TEST CHEM CAL LEVELS 1,2&3/ITEMS 67617 ABC/95

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·Dimension TPSA Flex reagent cartridge (RF451)