I-STOP TRANS OBTURATOR MALE SLING

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

I.B.S SNAP-OFF SCREW / SOLAFIX SNAP-OFF SCREW

FDA 510(k)

FDA Class 2 ·Orthopedic

Newclip Patient-matched instrumentation non sterile PSI

FDA 510(k)

FDA Class 2 ·Orthopedic

ABX PENTRA GLUCOSE HK CP, UREA CP, URIC ACID CP

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PENTRA C200, ISE MODULE AND ABX PENTRA GLUCOSE HK CP REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VIDAS NEPHROCHECK

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

INNOVA EPVISION 2.0, INNOVA EPVISION 2.0

FDA 510(k)

FDA Class 2 ·Radiology

SENOGRAPHE ESSENTIAL, PREMIUM VIEW I (PVI)

FDA 510(k)

FDA Class 2 ·Radiology

ABX PENTRA 400, CALCIUM CP, CREATININE CP, PHOSPHORUS CP, AMYLASE CP, URINE CONTROL L/H

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ETEST Delafloxacin (DFX) (0.002-32 µg/mL)

FDA 510(k)

FDA Class 2 ·Microbiology

Sonio Suspect

FDA 510(k)

FDA Class 2 ·Radiology

Idys ALIF ZP 3DTi

FDA 510(k)

FDA Class 2 ·Orthopedic

QIR Suite

FDA 510(k)

FDA Class 2 ·Radiology

LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

breastscape v1.0

FDA 510(k)

FDA Class 2 ·Radiology

Parietex Progrip Mesh (new name: Progrip Self-Gripping Polyester Mesh), Parietex Plug and Patch (new name : Parietex Plug and Patch System), Progrip Laparoscopic Self-Fixating Mesh

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

NOVATECH TALCAIR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

S-57 VIDEO IMAGING SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

LigaPASS

FDA 510(k)

FDA Class 2 ·Orthopedic

Twin Peaks Lumbar Interbody Fusion System

FDA 510(k)

FDA Class 2 ·Orthopedic