Axial3D Cloud Segmentation Service

FDA 510(k)

FDA Class 2 ·Radiology

GentleCath Intermittent Urinary Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GentleCath Glide Intermittent Urinary Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Cure Twist Female 8 Catheter (T8); Cure Twist Female 10 Catheter (T10); Cure Twist Female 12 Catheter (T12); Cure Twist Female 14 Catheter (T14); Cure Twist Female 16 Catheter (T16); Cure Twist Female 8 Catheter Kit with supplies (T8K); Cure Twist Female 10 Catheter Kit with supplies (T10K); Cure Twist Female 12 Catheter Kit with supplies (T12K); Cure Twist Female 14 Catheter Kit with supplies (T14K); Cure Twist Female 16 Catheter Kit with supplies (T16K)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GENTLECATH MALE COUDE OLIVE TIP INTERMITTENT URINARY CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Axial3D Cloud Segmentation Service

FDA 510(k)

FDA Class 2 ·Radiology

POLY-TAPES WITH THE FASTLOK FIXATION DEVICE

FDA 510(k)

FDA Class 2 ·Orthopedic

Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Catheter Insertion Kit (K2-90); Cure Catheter Insertion Kit (K3); Cure Hydrophilic Catheter Kit (HM12UK); Cure Hydrophilic Catheter Kit (HM14UK); Cure Hydrophilic Catheter Kit (HM16UK); Cure Pocket Catheter Kit (M14UK); Cure Catheter Closed System Kit (CS8); Cure Catheter Closed System Kit (CS10); Cure Catheter Closed System Kit (CS12); Cure Catheter Closed System Kit (CS14); Cure Catheter Closed System Kit (CS14C

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Flexi-Seal AIR (with ENFit Connector)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Axial3D Insight

FDA 510(k)

FDA Class 2 ·Radiology

Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AVELLE Negative Pressure Wound Therapy System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Flexi-Seal Signal Fecal Management System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

POLY-TAPES (VARIOUS SIZES AND WOVEN CONSTRUCTION VARIANTS)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Axial3D Insight

FDA 510(k)

FDA Class 2 ·Radiology

GentleCath Glide Intermittent Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CRADLE FIXATION DEVICE

FDA 510(k)

FDA Class 2 ·Orthopedic

Q-Switched Nd:YAG Laser System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery