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PROABLE PULSE OXIMETER, MODEL MD-600P, TRAVELER OXIMETER, MODEL MD-650P AND PALM PULSE OXIMETER, MODEL MD-680P

FDA 510(k)
FDA Class 2 ·Cardiovascular

digene® HC2 CT/GC DNA Test

FDA UDI
QIAGEN SCIENCES INC.·04053228010265·

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval
FDA Class 3 ·EZ STEER NAV

Ventricular (Assist) Bypass

FDA Pre-Market Approval
FDA Class 3 ·HeartWare™ HVAD System

Straumann BLX Ø3.5 mm Implants

FDA 510(k)
FDA Class 2 ·Dental

NOVA CO-OXIMETER ANALYZER

FDA 510(k)
FDA Class 2 ·Hematology

NOVA CHEMISTRY LINEARITY SET F, LEVELS 1, 2, 3, AND 4

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

NOVA 16 ANALYZER (MODIFICATION POINT OF CARE USAGE)

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

STAT PROFILE ULTRA 11 ANALYZER (MODIFICATION)

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

STAT PROFILE PHOX ANALYZER

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

STAT PROFILE PHOX CO-OXIMETER ANALYZER, NOVA CO-OXIMETER CONTROLS, LEVELS 1 AND 2, NOVA CO-OXIMETER THB CALIBRATOR

FDA 510(k)
FDA Class 2 ·Hematology

ZPower Rechargeable System for Hearing Aids

FDA UDI
ZPOWER, LLC·00850034007335·ZPower Rechargeable System for Hearing Aids Kit...

ACODE SPORTING GOODS COMPANY LIMITED

FDA registration
ACODE SPORTING GOODS COMPANY LIMITED·1 product·🇻🇳 Vietnam

ACODE SPORTING GOODS COMPANY LIMITED

FDA registration
ACODE SPORTING GOODS COMPANY LIMITED·1 product·🇻🇳 Vietnam

ACODE SPORTING GOODS COMPANY LIMITED

FDA registration
ACODE SPORTING GOODS COMPANY LIMITED·1 product·🇻🇳 Vietnam

ACODE SPORTING GOODS COMPANY LIMITED

FDA registration
ACODE SPORTING GOODS COMPANY LIMITED·1 product·🇻🇳 Vietnam

ACODE SPORTING GOODS COMPANY LIMITED

FDA registration
ACODE SPORTING GOODS COMPANY LIMITED·1 product·🇻🇳 Vietnam

Procleix® WNV/Babesia Quality Control

FDA registration
Grifols Diagnostic Solutions Inc.·1 product·🇺🇸 United States

Procleix® HIV-1/HCV/HBV Quality Control

FDA registration
Grifols Diagnostic Solutions Inc.·1 product·🇺🇸 United States

Sekisui Diagnostics P.E.I. Inc.

FDA registration
Sekisui Diagnostics P.E.I. Inc.·3 products·🇨🇦 Canada