T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System

FDA 510(k)

FDA Class 2 ·Orthopedic

Normandy VBR System

FDA 510(k)

FDA Class 2 ·Orthopedic

CLINICAL NEURO SYSTEMS MONITORR ICP LUMBAR CATHETE

FDA 510(k)

FDA Class 2 ·Neurology

SAPPHIRE PLASMA ARC DENTAL CURING LIGHT

FDA 510(k)

FDA Class 2 ·Dental

Revolution Spinal Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

MyClearALIGN Dental Aligner System

FDA 510(k)

FDA Class 2 ·Dental

ICONACY I-HIP SYSTEM, GRADUAL TRANSITIONING (GT) FEMORAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

XPRESSWAY RX CATHETER (6F LD-VERISON)

FDA 510(k)

FDA Class 2 ·Cardiovascular

1.5T SIGNA HDXT 3.0T SIGNA HDXT SIGNA VIBRANT

FDA 510(k)

FDA Class 2 ·Radiology

LifeFlow Rapid Infusion Device (LifeFlow Device)

FDA 510(k)

FDA Class 2 ·General Hospital

ETHICON ENDO-SURGERY GENERATOR G11, MODEL GEN11

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Harvest Conceal ZR Block Out

FDA 510(k)

FDA Class 2 ·Dental

Longeviti ClearFit Cranial Implant

FDA 510(k)

FDA Class 2 ·Neurology

Longeviti ClearFit™ OTS Cranial Implants

FDA 510(k)

FDA Class 2 ·Neurology

SSP PEDICLE SCREW SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

ULTRALIGHT II ND:YAG LASER SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SIGNA Premier

FDA 510(k)

FDA Class 2 ·Radiology

LIGHTSPEED 7.1 CT SCANNER SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

THERMOAIRE SPLINT (TM) (TAS)

FDA 510(k)

FDA Class 2 ·Physical Medicine

ENSEAL X1 Large Jaw Tissue Sealer

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery