2,340 results · 46ms · Sources: EU EUDAMED, US FDA

BD Phoenix™ Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL)

FDA 510(k)
FDA Class 2 ·Microbiology

CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR AND ARTERIAL FILTER

FDA 510(k)
FDA Class 2 ·Cardiovascular

SUSTAIN

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

NANMA VACUUM PUMP

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

SPORICIDIN STERILIZING AND DISINFECTING SOLUTION (SSDS)

FDA 510(k)
FDA Class 2 ·General Hospital

IOB Temperature Management System

FDA 510(k)
FDA Class 2 ·Cardiovascular

REMED MALE LATEX CONDOM (SUPER DUPER) PREVENTOR, LUCKY BOY, AND SUMMIT

FDA 510(k)
FDA Class 2 ·Obstetrics/Gynecology

CPU-1 INTENSIVE CARE VENTILATOR

FDA 510(k)
FDA Class 2 ·Anesthesiology

DIABETESMANAGER SYSTEM, DIABETESMANAGER-RX SYSTEM MODEL VERSION 1.1

FDA 510(k)
FDA Class 2 ·General Hospital

LOW PROFILE NEEDLE ELECTRODE (N-SPYRAL LP)

FDA 510(k)
FDA Class 2 ·Neurology

CLIRANS TE12 HOLLOW FIBER DIALYZER

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

VARI-ANGLE HIP SCREW (VHS) SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

GORE SYNECOR Biomaterial

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

PC/QCT QUANTITATIVE SOFTWARE

FDA 510(k)
FDA Class 2 ·Radiology

COPALIS TREPONEMAL ANTIGEN TOTAL ANTIBODY ASSAY

FDA 510(k)
FDA Class 2 ·Microbiology

SILIMED PECTORAL IMPLANT

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

BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM

FDA 510(k)
FDA Class 2 ·General Hospital

LIFELINES IEEG

FDA 510(k)
FDA Class 2 ·Neurology

Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Reservoir, Terumo Capiox FX25 Advance Oxygenator with Integrated Arterial Filter and Reservoir

FDA 510(k)
FDA Class 2 ·Cardiovascular

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTAZIDIME 0.5-64 UG/ML-GRAM-NEGATIVE ID/AST OR AST ONLY PHOENIX PANELS

FDA 510(k)
FDA Class 2 ·Microbiology