CARDIO CK-B RIA KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

LKB 2161 MIDISPIN R CENTRIFUGE

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

ANALYZER-SUPPLEMENT, KINETIC, LKB 2086

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

LKB-BROMMA 2188 ULTROTOME NOVA

FDA 510(k)

FDA Class 1 ·Pathology

LKB 4057 ULTROSPEC II E

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

LKB-WALLAC 1230 ARCUS FLUOROMETER

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

MKB SYSTEM

Device

EU MDR · Eu Md Class 1 ·MKB MEDICAL SYSTEM SRL·On the market

MKB SYSTEMS

Device

EU MDR · Eu Md Class 1 ·MKB MEDICAL SYSTEM SRL·On the market

LAPAROSCOPIC RETRACTORS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

STERILE WATER FOR INHALATION FLEX BAG, USP

FDA 510(k)

FDA Class 2 ·Anesthesiology

SPETZLER SCALP RETRACTOR CLAMPS (VARIOUS STYLES AND SIZES)

FDA 510(k)

FDA Class 2 ·Neurology

INFLATABLE BONE TAMP

FDA 510(k)

FDA Class 2 ·Orthopedic

DIAGNOSTIC CATHETER SYSTEM

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

AVAFLEX VERTEBRAL AUGMENTATION NEEDLE

FDA 510(k)

FDA Class 2 ·Orthopedic

COAXIAL BONE AND VERTEBRAL BODY BIOPSY NEEDLE MODEL# JBC1213, JBC1208

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·PK-175/2,3m Patient Cable, PK-83, 2.5m

Multi-Analyte DAU Calibrator Set D, Negative Calibrator

FDA UDI

LIN-ZHI INTERNATIONAL, INC.·B07608710·15 mL/bottle. Concentration: negative (drug-fre...

Pointe Multi-Analyte E DAU Cutoff Calibrator

FDA UDI

POINTE SCIENTIFIC, INC.·00811727017703·Pointe Multi-Analyte E DAU Cutoff Calibrator 1 ...

Pointe Multi-Analyte Set C Urine DAU Cutoff Calibrator

FDA UDI

POINTE SCIENTIFIC, INC.·00811727017567·Pointe Multi-Analyte Set C Urine DAU Cutoff Cal...

Preciset TDM II

FDA UDI

Roche Diagnostics GmbH·04015630996971·