SOFT BEAT FETAL HEART RATE ELECTRODE MODEL SBT-7000

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack, Simplexa C. auris Sample Prep Kit (MOL3950, MOL3960, MOL5390)

FDA 510(k)

FDA Class 2 ·Microbiology

MobileECG 2 BT

FDA 510(k)

FDA Class 2 ·Cardiovascular

ABT 4000 VENTILATOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

EZ-PAK (EZ-PAK IS A TRADEMARK OF IBT S.A.)

FDA 510(k)

FDA Class 2 ·Radiology

OPTISTRAND, MODEL 1032S

FDA 510(k)

FDA Class 2 ·Radiology

INTERSTRAND 125 & INTERSTRAND 103, MODEL NUMBERS 1251S AND 1031S

FDA 510(k)

FDA Class 2 ·Radiology

SUNGLASSES

FDA 510(k)

FDA Class 1 ·Ophthalmic

SUNGLASSES

FDA 510(k)

FDA Class 1 ·Ophthalmic

ABT GLUCOSE CONTROL SOLUTION

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

THORA-DRAIN(R) ABT SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

SAFESTRETCH INCONTINENCE SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SAFESEAL REUSABLE URINAL SYSTEM

FDA 510(k)

FDA Class 1 ·Gastroenterology, Urology

OSTOMY BAGS URETHEROSTOMY

FDA 510(k)

FDA Class 1 ·Gastroenterology, Urology

OSTOMY BAGS COLOSTOMY

FDA 510(k)

FDA Class 1 ·Gastroenterology, Urology

OSTOMY BAGS ILEOSTOMY

FDA 510(k)

FDA Class 1 ·Gastroenterology, Urology

AAIO-7, AAIO WIRLESS

FDA 510(k)

FDA Class 2 ·Ophthalmic

APPASAMY SLIT LAMP, A1A-11 AND A1A-12 SERIES

FDA 510(k)

FDA Class 2 ·Ophthalmic

ABT GLUCOSE CONTROL SOLUTION, MODEL: 2120089

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

ABT GLUCOSE CONTROL SOLUTION, MODEL 2120090

FDA 510(k)

FDA Class 1 ·Clinical Chemistry