209 results · 22ms · Sources: EU EUDAMED, US FDA

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Pre-Market Approval
FDA Class 2 ·API-1 STANDARDIZED ANTIMICROBIC SUSCEPTIBILITY SYS

ActTrust

FDA 510(k)
FDA Class 2 ·Neurology

Mini-OSTEO Pedicle Fixation System

FDA 510(k)
FDA Class 2 ·Orthopedic

MOTILITY CATHETERS

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

COMPACT DIGITAL BLOOD PRESSURE MONITOR

FDA 510(k)
FDA Class 2 ·Cardiovascular

EASYPLUS MINI SELF MONITORING GLUCOSE TEST SYSTEM, MODELS R1 AND R2

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Rainbow 360

FDA 510(k)
FDA Class 2 ·Dental

WRIST PULSE OXIMETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

EDGE SYRINGES AND NEEDLES

FDA 510(k)
FDA Class 2 ·General Hospital

Pulse Oximeter (MD300M/MD300K2)

FDA 510(k)
FDA Class 2 ·Cardiovascular

GEMORE MUSCLE CONDITIONER;

FDA 510(k)
FDA Class 2 ·Physical Medicine

FINGERTIP PULSE OXIMETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

Surgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80)

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

Electronic Stethoscope DS301

FDA 510(k)
FDA Class 2 ·Cardiovascular

FINGERTIP PULSE OXIMETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

“BRAXX” Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002)

FDA 510(k)
FDA Class 2 ·Radiology

Red Wave Hair Removal

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

BROADMASTER HEALTHCARE SYSTEM

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

EG V1 (BL) SELF MONITORING GLUCOSE TEST SYSTEM MODEL: EPS10017

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Air Compression Therapy System

FDA 510(k)
FDA Class 2 ·Physical Medicine