AESCULAP SPINE SYSTEM ADDITIONAL COMPONENTS

FDA 510(k)

FDA Class 2 ·Orthopedic

CPR Face Shield

FDA 510(k)

FDA Class 2 ·Anesthesiology

Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models F2, F3

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

MICROTHERM MT-501 & MT-502

FDA 510(k)

FDA Class 2 ·General Hospital

SD1 Ultrasonic Pocket Doppler

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Central Monitoring System

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

AESCULAP ABC CERVICAL PLATING SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

AESCULAP SPINE SYSTEM EVOLUTION

FDA 510(k)

FDA Class 2 ·Orthopedic

Medical Surgical Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Aquilion Precision (TSX-304A/4) V10.14 with AiCE

FDA 510(k)

FDA Class 2 ·Radiology

Aquilion ONE (TSX-305A/6) V8.9 with AiCE

FDA 510(k)

FDA Class 2 ·Radiology

Aquilion Precision (TSX-304A/4) V10.10 with AiCE

FDA 510(k)

FDA Class 2 ·Radiology

AutoMIStar

FDA 510(k)

FDA Class 2 ·Radiology

QUICKAIR CHOKE RELIEVER, MODEL 59-001A

FDA 510(k)

FDA Class 2 ·Anesthesiology

ZED Link

FDA 510(k)

FDA Class 2 ·Radiology

NORMOCARB STERILE BICARBONATE RENAL DIALYSIS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Neodent Implant System

FDA 510(k)

FDA Class 2 ·Dental

Catheter, Angioplasty, Peripheral, Transluminal

FDA Pre-Market Approval

FDA Class 2 ·FLEXTOME CUTTING BALLOON MONORAIL(MR)/OVER THE WIRE(OTW)

Catheter, Angioplasty, Peripheral, Transluminal

FDA Pre-Market Approval

FDA Class 2 ·ULTRA2 CUTTING BALLOON MONORAIL(MR)

Catheter, Angioplasty, Peripheral, Transluminal

FDA Pre-Market Approval

FDA Class 2 ·CUTTING BALLOON MONORAIL(MR)/OVER THE WIRE(OTW)