ZZIREN™ Orogastric Tube; ZZIREN™ SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN™ SGT Orogastric Tube - 36 Fr (ZZ-SGT-36); ZZIREN™ SGT Orogastric Tube - 40 Fr (ZZ-SGT-40); ZZIREN™ GBT Orogastric Tube - 32 Fr (ZZ-GBT-32); ZZIREN™ GBT Orogastric Tube - 36 Fr (ZZ-GBT-36); ZZIREN™ GBT Orogastric Tube - 40 Fr (ZZ-GBT-40)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

TRI-MED QUICK-STEP(TM) RECTAL TUBE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SIGMOID TONOMITOR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

INFLATABLE RETENTION CUFF SPECULUM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Catheter, Rectal

FDA classification

FDA Class 2 ·Catheter, Rectal

MobileECG 2 BT

FDA 510(k)

FDA Class 2 ·Cardiovascular

ABT 4000 VENTILATOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

THORA-DRAIN(R) ABT SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

FLUOREX ULTRA (FLUSILFOCON E) RIGID GAS PERMEABLE CONTACT LENS

FDA 510(k)

FDA Class 2 ·Ophthalmic

SAFESTRETCH INCONTINENCE SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

FLUOREX 700 -UV (FLUSILFOCON A), FLUOREX 500-UV (FLUSILFOCON B) AND FLUOREX 300-UV (FLUSILFOCON C) RIGID GAS PERMEABLE C

FDA 510(k)

FDA Class 2 ·Ophthalmic

DIMENSION VISTA LG LIGHT CHAINS, TYPE KAPPA, DIMENSION VISTA LG LIGHT CHAINS, TYPE LAMBDA, DIMENSION VISTA PROTEIN 1 CAL

FDA 510(k)

FDA Class 2 ·Immunology

XENX

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BERICHROM HEPARIN LMW CALIBRATOR, BERICHROM HEPARIN LMW CONTROL 1, AND BERICHROM HEPARIN LMW CONTROL 2

FDA 510(k)

FDA Class 2 ·Hematology

Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC CAL)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BERICHROM HEPARIN UF CALIBRATOR, BERICHROM HEPARIN UF CONTROL 1, AND BERICHROM HEPARIN UF CONTROL 2

FDA 510(k)

FDA Class 2 ·Hematology

Dimension Vista MMB Assay

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DIMENSION MYCOPHENOLIC ACID (MPAT) FLEX REAGENT CARTRIDGE, DIMENSION MYCOPHENOLIC ACID CALIBRATOR (MPAT CAL)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

DIMENSION VISTA ALKALINE PHOSPHATASE (ALPI) FLEX REAGENT CARTRIDGE DIMENSION VISTA ALKALINE PHOSPHATASE CALIBRATOR (ALPI

FDA 510(k)

FDA Class 2 ·Clinical Chemistry