16 results · 46ms · Sources: EU EUDAMED, US FDA

Stat Troponin I

FDA registration
Microgenics Corporation·1 product·🇺🇸 United States

ARCHITECT STAT Troponin-I Controls - LN 02K4110

FDA registration
ABBOTT LABORATORIES·1 product·🇺🇸 United States

ABBOTT ARCHITECT STAT TROPONIN I LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL L, M AND H

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

ZIMMER PTE. LTD.

FDA registration
ZIMMER PTE. LTD.·1 product·🇸🇬 Singapore

MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM

FDA registration
BIOMET, INC.·1 product·🇺🇸 United States

CRP HIGH SENSITIVITY TEST SYSTEM

FDA registration
CLINIQA CORPORATION·2 products·🇺🇸 United States

Zimmer (Shanghai) Medical International Trading Co., Ltd.

FDA registration
Zimmer (Shanghai) Medical International Trading Co., Ltd.·1 product·🇨🇳 China

Zimmer Biomet Pty Ltd

FDA registration
Zimmer Biomet Pty Ltd·1 product·🇦🇺 Australia

EBI® XFIX® Vision® Fixation System

FDA registration
LX PRECISION SHANGHAI CO LTD·1 product·🇨🇳 China

Fusion

FDA registration
ZHONGSHAN A&J MEDICAL EQUIPMENT CO., LTD.·1 product·🇨🇳 China

STERICHEK TOTAL CHLORINE REAGENT STRIPS

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

22G X 1 1/2" EDGE SAFETY NEEDLE WITH 3 ML LL SYRINGE 400/CA Hypodermic Needle-Pro Edge Device w/syringe

FDA registration
Sterigenics U.S., LLC·1 product·🇺🇸 United States

Single (Specified) Analyte Controls (Assayed And Unassayed)

FDA classification
FDA Class 1 ·Single (Specified) Analyte Controls (Assayed And Unassayed)

Strip, Test, Reagent, Residuals For Dialysate, Disinfectant

FDA classification
FDA Class 2 ·Strip, Test, Reagent, Residuals For Dialysate, Disinfectant

Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

FDA classification
FDA Class 2 ·Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component