Senographe Pristina

FDA 510(k)

FDA Class 2 ·Radiology

HEPATIC ENZYMES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PURTIAN BENNETT, GOOD KNIGHT 420G MODEL M-113900-US; PURTAN BENNETT, GOODKNIGHT 420S MODEL M-113903-US

FDA 510(k)

FDA Class 2 ·Anesthesiology

Nexis osteosynthesis compressive screws

FDA 510(k)

FDA Class 2 ·Orthopedic

FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630)

FDA 510(k)

FDA Class 2 ·Radiology

Cannulated PediGuard Needle#1, Cannulated PediGuard Needle#2, Cannulated PediGuard Needle 120mm, Cannulated PediGuard Handle; PediGuard Tri Tip Ø4.0mm, PediGuard Tri Tip Ø3.2mm, PediGuard Tri Tip Ø2.5mm, PediGuard Ø2.5mm XS, PediGuard Curv, PediGuard Curv XS

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

SALTO TALARIS TOTAL ANKLE PROSTHESIS, RHS

FDA 510(k)

FDA Class 2 ·Orthopedic

Salto XT, Salto Talaris

FDA 510(k)

FDA Class 2 ·Orthopedic

V-STRUT® Vertebral Implant

FDA 510(k)

FDA Class 2 ·Orthopedic

ALUMINA HEAD

FDA 510(k)

FDA Class 2 ·Orthopedic

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