48 results · 18ms · Sources: EU EUDAMED, US FDA

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HCI MECONIUM ASPIRATOR

FDA 510(k)
FDA Class 1 ·Anesthesiology

HCI Y-CONNECTOR

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

HCI TUBE STABILIZER

FDA 510(k)
FDA Class 1 ·Anesthesiology

DS30 HCY BLOOD COLLECTION TUBES

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

HCI GENERAL PURPOSE CATHETER STYLET

FDA 510(k)
FDA Class 1 ·General, Plastic Surgery

DS30 HCY HOMOCYSTEINE ASSAY KIT

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

VITROS CHEMISTRY PRODUCTS HCY REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 27, HCY PERFORMANCE VERIFIERS

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

HCI ALL PURPOSE DRAIN/CATHETER SET

FDA 510(k)
FDA Class 1 ·General, Plastic Surgery

VITROS CHEMISTRY PRODUCTS HCY 2 REAGENT, CALIBRATOR KIT 27, HCY 2 PERFORMANCE VERIFIERS I, II AND III

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

N LATEX HCY, N PROTEIN STANDARD SL, N/T PROTEIN CONTROL L/M/H

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ACIES

FDA 510(k)
FDA Class 2 ·Radiology

BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm)

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602 Sizer Kit, BCI 602 Lifts (1mm)

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

MDx-Chex for BCY

FDA 510(k)
FDA Class 2 ·Microbiology

BCI 3180 PULSE OXIMETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

BCI WW1030 PULSE OXIMETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

ACI SILICATH THORACIC CATHETER

FDA 510(k)
FDA Class 1 ·General, Plastic Surgery

BCI WW1021 PC APPLICATION

FDA 510(k)
FDA Class 2 ·Cardiovascular

ACI PULSATING VACUUM PUMP SYSTEM

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

BCI 3401 HANDHELD PULSE OXIMETER

FDA 510(k)
FDA Class 2 ·Cardiovascular