V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 1 Plus Low Temperature Sterilization System, V-PRO 1 Low Temperature Sterilization System

FDA 510(k)

FDA Class 2 ·General Hospital

HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102); HydroMID 5F Dual Lumen Midline Catheter - Max Barrier Kit (70006104); HydroMID 5F Dual Lumen Midline Catheter - Mobile Max Barrier Kit (90006104)

FDA 510(k)

FDA Class 2 ·General Hospital

X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology)

FDA 510(k)

FDA Class 2 ·Radiology

X-MIND prime (under trade mark Acteon), I-MAX (under trade mark Owandy Radiology)

FDA 510(k)

FDA Class 2 ·Dental

Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (under trade mark Owandy Radiology)

FDA 510(k)

FDA Class 2 ·Dental

BLUE MAX BALLOON DILATATION CATHETER, MAXFORCE BALLOON CATHETER, XXL BALLOON DILATATION CATHATER, SYMMETRY BALLOON DILA

FDA 510(k)

FDA Class 2 ·Cardiovascular

OMNIPULSE HOLMIUM LASER SYSTEM, OMNIPULSE-MAX HOLMIUM LASER SYSTEM, MODEL 1210, 1210-VHP, 1500-A

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ATTO Mobility Scooter (ATTO);ATTO Mobility Scooter (ATTO SPORT);ATTO Mobility Scooter (ATTO SPORT MAX)

FDA 510(k)

FDA Class 2 ·Physical Medicine

OMNIPULSE HOLMIUM LASER SYSTEM MODEL 1210, OMNIPULSE-MAX HOLMIUM LASER SYSTEM MODELS 1210-VHP, 1500A

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

RMNIPULSE HOLMIUM LASER SYSTEM/1210; MAX/1210-VHP; JR. 1230-30; N/A 1500-A

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart App

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

4-WEB ALIF SPINAL TRUSS SYSTEM (STS)

FDA 510(k)

FDA Class 2 ·Orthopedic

Testa TP Pivoting Spacer System

FDA 510(k)

FDA Class 2 ·Orthopedic

Tranquil Interbody System

FDA 510(k)

FDA Class 2 ·Orthopedic

Ti-Diagon Oblique TLIF

FDA 510(k)

FDA Class 2 ·Orthopedic

LumFuse-TP

FDA 510(k)

FDA Class 2 ·Orthopedic

REDONDO-L

FDA 510(k)

FDA Class 2 ·Orthopedic

ACCULIF TL AND PL CAGE

FDA 510(k)

FDA Class 2 ·Orthopedic

ZSFab Lumbar Interbody System

FDA 510(k)

FDA Class 2 ·Orthopedic

Xsert Lumbar Expandable Interbody System

FDA 510(k)

FDA Class 2 ·Orthopedic