TUBING PACK, EXTRACORPOREAL, H-3000

FDA 510(k)

FDA Class 2 ·Cardiovascular

Nautilus VF ECMO Oxygenator

FDA 510(k)

FDA Class 2 ·Cardiovascular

Nautilus Smart ECMO Module

FDA 510(k)

FDA Class 2 ·Cardiovascular

Nd: YAG Laser Therapy Systems

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Diode Laser Therapy Systems

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

INTENSE PULSED LIGHT (IPL) SYSTEMS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BioXmark

FDA 510(k)

FDA Class 2 ·Radiology

Hydrozid

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DISTAL CLAVICULAR FRAGMENT IMMOBILIZATION PLATE LEFT, MODEL 1810-116_126-03 (05,07) RIGHT 1811-116_126-03 (05,07)

FDA 510(k)

FDA Class 2 ·Orthopedic

UNISYN IMAGE FUSION, VERSION 1.0

FDA 510(k)

FDA Class 2 ·Radiology

TERRAY STAINLESS STEEL ROD (STRAIGHT, L, RECTANGLE)

FDA 510(k)

FDA Class 2 ·Orthopedic

MTP RESESURFACING JOINT-SMALL/9301-01; MEDIUM/9301-02; LARGE/9301-03

FDA 510(k)

FDA Class 2 ·Orthopedic

FaceHeart Vitals Software Development Kit (FH vitals SDK)

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARPAL ENGAGING WRIST FUSION PLATE

FDA 510(k)

FDA Class 2 ·Orthopedic

UniSyn Molecular Imaging (6-3-1)

FDA 510(k)

FDA Class 2 ·Radiology

FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)

FDA 510(k)

FDA Class 2 ·Anesthesiology

Susceptibility Test Powders, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·POTASSIUM PENICILLIN G DIAG SYS POWDER

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval

FDA Class 2 ·API-1 STANDARDIZED ANTIMICROBIC SUSCEPTIBILITY SYS

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval

FDA Class 2 ·API-1 STANDARDIZED ANTIMICROBIC SUSCEPTIBILITY SYS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MEDI-TECH CORONARY BALLOON DILATATION CATHETER SYS