INTEGRATED REGISTRATION

FDA 510(k)

FDA Class 2 ·Radiology

IMPIX ALIF S/A

FDA 510(k)

FDA Class 2 ·Orthopedic

Olea S.I.A. Neurovascular V1.0

FDA 510(k)

FDA Class 2 ·Radiology

OmniBone™ Bone Marrow Biopsy Kit with Power Driver, OmniBone™ Bone Biopsy Kit with Power Driver

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Olea Sphere V3.0

FDA 510(k)

FDA Class 2 ·Radiology

ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL)

FDA 510(k)

FDA Class 2 ·Microbiology

BEAM BLOCK TRAYS

FDA 510(k)

FDA Class 2 ·Radiology

ECG multi leads and IP-SET trunk cable, Monobloc ECG cable, SpO2 sensors and IBP transducers interface cable, ECG leadwire for INTEGRAL PROCESS trunk cables, ECG leadwire for original truk cables

FDA 510(k)

FDA Class 2 ·Cardiovascular

EUROSCREW NG; EUROSCREW TCP NG

FDA 510(k)

FDA Class 2 ·Orthopedic

AEQUALIS REVERSED SHOULDER PROSTHESIS

FDA 510(k)

FDA Class 2 ·Orthopedic

RHS

FDA 510(k)

FDA Class 2 ·Orthopedic

Endocular Viewing Lenses and Silicone Ring

FDA 510(k)

FDA Class 2 ·Ophthalmic

Sim&Size

FDA 510(k)

FDA Class 2 ·Radiology

HENNERT SA

FDA 510(k)

FDA Class 1 ·Ophthalmic

Perifit Pump

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

LENS SPECTACLE NON-CUSTOM (PRESCRIPTION)

FDA 510(k)

FDA Class 1 ·Ophthalmic

ARROW Off-Centred Humeral Insert

FDA 510(k)

FDA Class 2 ·Orthopedic

MammoScreen® (4)

FDA 510(k)

FDA Class 2 ·Radiology

AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERSED SHOULDER PROSTHESIS, AEQUALIS REVERSED FRACTURE SHOULDER PROSTHESIS

FDA 510(k)

FDA Class 2 ·Orthopedic

ALN Optional Vena Cava Filter (FB.010500, FF.010995, FJ.120096, FB.HOOK, FF.HOOK, FJ.HOOK)

FDA 510(k)

FDA Class 2 ·Cardiovascular