PherDal® At-Home Insemination Kit

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

AURIUM G13 (HIGH GOLD CROWN AND BRIDGE ALLOY)

FDA 510(k)

FDA Class 2 ·Dental

BESMED VARIOUS MODELS OF POWERED MUSCLE STIMULATOR, BE-560/BE-580

FDA 510(k)

FDA Class 2 ·Physical Medicine

FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)

FDA 510(k)

FDA Class 2 ·Anesthesiology

AURIUM SG (HIGH GOLD CROWN AND BRIDGE ALLOY)

FDA 510(k)

FDA Class 2 ·Dental

BESMED VARIOUS MODELS OF TENS, BE-550/BE-660

FDA 510(k)

FDA Class 2 ·Neurology

AURIUM X6 (MEDIUM GOLD CROWN AND BRIDGE ALLOY)

FDA 510(k)

FDA Class 2 ·Dental

AUROLITE CB25

FDA 510(k)

FDA Class 2 ·Dental

AURIUM 20% (LOW GOLD CROWN AND BRIDGE ALLOY)

FDA 510(k)

FDA Class 2 ·Dental

AURIUM D17 (HIGH GOLD CROWN & BRIDGE ALLOY)

FDA 510(k)

FDA Class 2 ·Dental

Semi-automatic Biopsy-Needle (BIM 18/20); Semi-automatic Biopsy-Needle (BIM 18.15); Semi-automatic Biopsy-Needle (BIM 18/10);Semi-automatic Biopsy-Needle (BIM 16/20);Semi-automatic Biopsy-Needle (BIM 16/15);Semi-automatic Biopsy-Needle (BIM 16/10);Semi-automatic Biopsy-Needle (BIM 14/20);Semi-automatic Biopsy-Needle (BIM 14/15);Semi-automatic Biopsy-Needle (BIM 14/10)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AUROLITE 1C

FDA 510(k)

FDA Class 2 ·Dental

AMEDA/EGNELL DOLPHIN DISPO-SOFT VACUUM EXTRACTOR

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

GE DATEX-OHMEDA AISYS

FDA 510(k)

FDA Class 2 ·Anesthesiology

SUNDASH

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AMEDA/EGNELL DOLPHIN UMBILICAL CORD SEVERING DEVIC

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ENGSTROM CARESTATION, ENGSTROM PRO, MODELS 1505-9000-000, 1505-9003-000

FDA 510(k)

FDA Class 2 ·Anesthesiology

Voluson Expert 22, Voluson Expert 20, Voluson Expert 18

FDA 510(k)

FDA Class 2 ·Radiology

Voluson Expert 22, Voluson Expert 20, Voluson Expert 18

FDA 510(k)

FDA Class 2 ·Radiology

GE DATEX-OHMEDA AVANCE

FDA 510(k)

FDA Class 2 ·Anesthesiology