PTG-05

FDA 510(k)

FDA Class 2 ·Physical Medicine

CRYO 5

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ThermoTK

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ARION

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CoolTone

FDA 510(k)

FDA Class 2 ·Physical Medicine

PERMASOFT SOFT RELINE MATERIAL BY NU-DENT, INC.

FDA 510(k)

FDA Class 2 ·Dental

MU PHOTONICS PAIN THERAPIST

FDA 510(k)

FDA Class 2 ·Physical Medicine

Flexi-Seal PROTECT Fecal Management System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

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

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

NERIA SOFT 90 INFUSION SET

FDA 510(k)

FDA Class 2 ·General Hospital

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

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CLINIJEL

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

AVELLE Negative Pressure Wound Therapy System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery