PreXion 3D Excelsior

FDA 510(k)

FDA Class 2 ·Radiology

AUTION MAX AX-4060 Urinalysis System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SUPERCATH5

FDA 510(k)

FDA Class 2 ·General Hospital

PreXion3D Explorer PRO

FDA 510(k)

FDA Class 2 ·Radiology

CLEARFIL SE BOND 2 KIT; CLEARFIL SE BOND 2 VALUE PACK; CLEARFIL SE BOND 2 TRIAL PACK; CLEARFIL SE BOND 2 BOND; CLEARFIL

FDA 510(k)

FDA Class 2 ·Dental

WHILL Model R

FDA 510(k)

FDA Class 2 ·Physical Medicine

NaviCross 0.018

FDA 510(k)

FDA Class 2 ·Cardiovascular

TI-MAX Z45

FDA 510(k)

FDA Class 1 ·Dental

Glidewire GT

FDA 510(k)

FDA Class 2 ·Cardiovascular

SB Knife/Short type, SB Knife/Standard type, SB Knife/Jr type, SB Knife/Jr type - Long

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control Set

FDA 510(k)

FDA Class 2 ·Hematology

CERABIEN MiLai

FDA 510(k)

FDA Class 2 ·Dental

Noritake Super Porcelain EX-3

FDA 510(k)

FDA Class 2 ·Dental

FMD Peripheral Guide Wire F-18 Flex 400 (CSU415400259)

FDA 510(k)

FDA Class 2 ·Cardiovascular

KATANA Zirconia Block

FDA 510(k)

FDA Class 2 ·Dental

PANAVIA SA CEMENT HANDMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT HANDMIX (UNIVERSAL (A2), WHITE) PANAVIA S

FDA 510(k)

FDA Class 2 ·Dental

3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data System

FDA 510(k)

FDA Class 2 ·Ophthalmic

Crownjun Nylon Suture

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Asahi REXEED-S Series Dialyzer

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear), Introductory Kit (Universal (A2)), Introductory Kit (Clear), Sample Pack (Universal (A2)), Paste (Universal (A2)), Paste (Clear), Paste (Brown (A4)), Paste (White), Paste (Opaque), Try-in Paste (Universal (A2)), Try-in Paste (Clear), Try-in Paste (Brown (A4)), Try-in Paste (White), Try-in Paste (Opaque), Tooth Primer

FDA 510(k)

FDA Class 2 ·Dental