W.A.

FDA 510(k)

FDA Class 1 ·General Hospital

SYSMEX CC-800/PDA-410 W/TRI-MODAL LEUKOCYTE SIZE -

FDA 510(k)

FDA Class 2 ·Hematology

LIAC HWL

FDA 510(k)

FDA Class 2 ·Radiology

SPENSER SUNGLASSES AND SPORT SUNGLASSES

FDA 510(k)

FDA Class 1 ·Ophthalmic

MYHEALTHPOINT TELEHEALTH MANAGER

FDA 510(k)

FDA Class 2 ·Cardiovascular

Cysto-Gastro-Sets

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

TOTIM Patient Cushion Immobilization System

FDA 510(k)

FDA Class 2 ·Radiology

MyGlucoHealth Wireless System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ETEST Fosfomycin (FO) (0.032-512 µg/mL)

FDA 510(k)

FDA Class 2 ·Microbiology

LIAC S

FDA 510(k)

FDA Class 2 ·Radiology

SYSMEX E-5000 FULLY AUTOMATED HEMATOLOGY SYSTEM

FDA 510(k)

FDA Class 2 ·Hematology

SYMPHONY DEVICE

FDA 510(k)

FDA Class 2 ·Physical Medicine

ETEST Eravacycline (ERV) (0.002 – 32 µg/mL)

FDA 510(k)

FDA Class 2 ·Microbiology

MERITS WHEELCHAIR

FDA 510(k)

FDA Class 2 ·Physical Medicine

SYSMEX E-5000, FULLY AUTOMATED HEMATOLOGY SYS

FDA 510(k)

FDA Class 2 ·Hematology

SignalMark Lung Biopsy Site Marker

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Macroplastique Implants

FDA UDI

Uroplasty, Inc.·08717591240266·Soft tissue bulking agent indicated for transur...

Durasphere ® EXP

FDA UDI

Carbon Medical Technologies, Inc.·00858015005004·Injectable Bulking Agent

Bulkamid

FDA UDI

AXONICS MODULATION TECHNOLOGIES, INC.·10810005340493·Bulkamid 3mL

Bulkamid

FDA UDI

AXONICS MODULATION TECHNOLOGIES, INC.·10810005340509·Bulkamid Urethral Bulking System 2mL