NEW LEAD INTRODUCER KITS, VARIOUS MODELS

FDA 510(k)

FDA Class 2 ·Cardiovascular

MYLAB15/20 NEW INDICATIONS ULTRASOUND SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

NEW DETECTOR FOR TRANSCAM/POLARIS S315

FDA 510(k)

FDA Class 1 ·Radiology

NEW OPTIONAL PROBES FOR SSA-90A

FDA 510(k)

FDA Class 2 ·Radiology

NEW EXTRUSION VENDOR FOR POLYURETHANE TUBING

FDA 510(k)

FDA Class 3 ·Cardiovascular

NEW BLUE MAX BALLOON DILATATION CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

NEW ENZYMATIC SINGLE REAGENT FREE CHOL.

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

NEW SUN OPTICAL NON PRESCRIPTION SUNGLASSES

FDA 510(k)

FDA Class 1 ·Ophthalmic

PRIMA SYSTEM - OLD, BARTELS ELISA - NEW

FDA 510(k)

FDA Class 1 ·Microbiology

NEW SUPPORT SYS. FOR BEDRIDDEN PATIENTS

FDA 510(k)

FDA Class 2 ·General Hospital

COBE REN NEW-D DISPENSING KIT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NA

FDA UDI

Synthes GmbH·10886982055552·T15/2.5MM HEX CERCLAGE BUTTON- STERILE

Arthrex®

FDA UDI

ARTHREX, INC.·00888867369887·TigerTape Sternal Closure w/ Blunt NDL

Arthrex®

FDA UDI

ARTHREX, INC.·00888867369863·TigerTape Sternal Closure w/ Cutting NDL

New Deantronics Smoke Evacuation Adapter with 10mm connector. New Deantronics Smoke Evacuation Adapter with 22mm connector. New Deantronics Button Switch Electrosurgical Pencil with SA01 Adapter. New Deantronics Button Switch Electrosurgical Pencil with SA02 Adapter.

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

HANG FAI SUNGLASSES

FDA registration

Shenzhen Ping Shan New District Biao Jie Optical Factory·1 product·🇨🇳 China

DONGGUAN EVER WIN HI-TECH NEW MATERIALS CO., LTD.

FDA registration

DONGGUAN EVER WIN HI-TECH NEW MATERIALS CO., LTD.·1 product·🇨🇳 China

HANG FAI SPECTACLE FRAME

FDA registration

Shenzhen Ping Shan New District Biao Jie Optical Factory·1 product·🇨🇳 China

TCI-31 LIFELONG OVULATION TESTER

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

Para-Fix External Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic