8,152 results · 68ms · Sources: EU EUDAMED, US FDA

Low Ejection Fraction AI-ECG Algorithm

FDA 510(k)
FDA Class 2 ·Cardiovascular

SurgiMend PRS Meshed, Revize-X

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

Interject Injection Therapy Needle Catheter

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

MILAGRO INTERFERENCE SCREWS

FDA 510(k)
FDA Class 2 ·Orthopedic

UNSCENTED MENSTRUAL TAMPON, PLASTIC APPLICATOR

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

MICROVASIVE BALLOON GASTROSTOMY TUBE KIT

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

FLEXIBLE CYSTOSCOPE

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

SD 800 SONODIAGNOST ULTRASOUND IMAGING SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

THEREX LOW-PROFILE PORT 1.5MM I.D. X 2.7MM O.D. DETACHED CATHETER SYSTEM

FDA 510(k)
FDA Class 2 ·General Hospital

HOLOGIC QDR X-RAY BONE DENSITOMETER/MODELS SERIES 4500, 4000, 2000, 1000 AND HOLOGIC DELPHI X-RAY BONE DENSITOMETER

FDA 510(k)
FDA Class 2 ·Radiology

INVOcell

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

LYTENING 5

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

GYRUS ACMIL BIPOLARLAPROSCOPIC LOOP (PKS BILL)

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

CODMAN ANTERIOR CERVICAL SPINE PLATE SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

SERATEST ENA [SSA] KIT

FDA 510(k)
FDA Class 2 ·Immunology

HOLMES AIR PURIFIER MODELS HAP-240 & HAP-300

FDA 510(k)
FDA Class 2 ·General Hospital

ANGEL WING SAFETY BLOOD COLLECTION AND INFUSION SE

FDA 510(k)
FDA Class 2 ·General Hospital

ST/AR ST AND ARRHYTHMIA SOFTWARE

FDA 510(k)
FDA Class 2 ·Cardiovascular

FERTILMARQ HOME DIAGNOSTIC SCREENING TEST KIT FOR MALE INFERTILITY

FDA 510(k)
FDA Class 2 ·Hematology

NeuTrace EP Mapping System v.2.1

FDA 510(k)
FDA Class 2 ·Cardiovascular