9-190,9-200,9-210,9-220 AMPUTATION KNIVES, VARIOUS

FDA 510(k)

FDA Class 1 ·General, Plastic Surgery

GentleCath Intermittent Urinary Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DUPONT ACA DIGOXIN (DGN A) METHOD

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

HEARING AID, UNITRON UE3-D/DN

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

ACA(R) DIGOXIN ANALYTICAL TEST PACK (DGN)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Eagle device

FDA 510(k)

FDA Class 2 ·Ophthalmic

BIOTRONIK DN UNIPOLAR PE-60/4-DN &

FDA 510(k)

FDA Class 3 ·Cardiovascular

Surgical Face Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Dental Diode Laser System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

IPL Hair Removal Device Model: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

FLUOROPLUA CARDIAC AND/OR INSTAVIEW

FDA 510(k)

FDA Class 2 ·Radiology

INSTASPOT

FDA 510(k)

FDA Class 2 ·Radiology

INSTACINE

FDA 510(k)

FDA Class 1 ·Radiology

FLEXLAB 3.6, ACCELERATOR A3600

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Flexi-Seal PROTECT Fecal Management System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GentleCath Glide Intermittent Urinary Catheter

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 PROTECT PLUS Fecal Management System (with ENFit Connector)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GentleCath Glide Intermittent Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PHENYTOIN CALIBRATORS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology