26 results · 16ms · Sources: EU EUDAMED, US FDA

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ARx® SAI Implant System

FDA 510(k)
FDA Class 2 ·Orthopedic

ARx® SAI Implant System

FDA 510(k)
FDA Class 2 ·Orthopedic

Ankle Fusion Cage

FDA classification
FDA Class 2 ·Ankle Fusion Cage

CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated Screw System, EXPEDIUM SFX Cross Connectors, EXPEDIUM Spine System, EXPEDIUM VERSE Spine System, E-Z Link Cross Connectors, ISOLA Spine System, MONARCH Spine System, MOSS MIAMI Spine System, TiMX Low Back System, VIPER Fenestrated Screw System, VIPER PRIME System, VIPER PRIME Fenestrated Screws, VIPER SAI (Sacral-Alar-Iliac), VIPER System, VIPER 2 System, VSP Spine System

FDA 510(k)
FDA Class 2 ·Orthopedic

ASI Automated ASI RPR Test for Syphilis on the ASI Evolution

FDA 510(k)
FDA Class 2 ·Microbiology

ASI Evolution

FDA 510(k)
FDA Class 2 ·Microbiology

ASI REAGENT

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

ASI HEMOSTASIS CATHETER

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

ASI Plethysmogrpah Analyzer

FDA 510(k)
FDA Class 2 ·Cardiovascular

ASI UROPLASTY LASER CYSTOSCOPE

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

ASI CYSTOLASE LASER CYSTOSCOPE

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

AUTO-SAFETY INJECTOR-2 (ASI-2)

FDA 510(k)
FDA Class 2 ·General Hospital

ASI LIGASURE(TM) SUTURE LIGATION INSTRUMENT

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

BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack))

FDA 510(k)
FDA Class 2 ·Microbiology

ASI TCU PROSTATIC URETHROPLASTY CATHETER & ACCESS.

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

ASI CYSTOSCOPE SHEATH, GRASPING FORCEPS & FOR.BODY

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

SYNTHES TI-6AI-7NB UNREAMED FEMORAL NAIL

FDA 510(k)
FDA Class 2 ·Orthopedic

TOTIM Patient Cushion Immobilization System

FDA 510(k)
FDA Class 2 ·Radiology

ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer

FDA 510(k)
FDA Class 2 ·Microbiology

JBAIDS TULAREMIA DETECTION KIT, MODEL JRPD-ASY-0124

FDA 510(k)
FDA Class 2 ·Microbiology