QUANTIEN Measurement System

FDA 510(k)

FDA Class 2 ·Cardiovascular

FlexCath Advance Steerable Sheath and Dilator

FDA 510(k)

FDA Class 2 ·Cardiovascular

METEL URETERAL BASKET STONE DISLODGER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODIFIED SCHNEIDER-SHILEY FLUSHING CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

Cepheid Xpert Respiratory Control Panel

FDA 510(k)

FDA Class 2 ·Microbiology

FIXATE TISSUE BAND

FDA 510(k)

FDA Class 2 ·Neurology

D. FARINAE ALLERGEN DISC

FDA 510(k)

FDA Class 2 ·Immunology

ORTHOMET AUSTIN-MOORE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Amplatzer Steerable Delivery Sheath

FDA 510(k)

FDA Class 2 ·Cardiovascular

AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid

FDA 510(k)

FDA Class 2 ·Orthopedic

COMPAT NASOJEJUNAL FEEDING TUBE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

LUMAX (MODIFICATION)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ATTAIN COMMAND 6250 LEFT HEART DELIVERY SYSTEMS AND GUIDE CATHETERS FOR LEFT HEART DELIVERY

FDA 510(k)

FDA Class 2 ·Cardiovascular

ANGEMED MODEL 4000 QC BIPOLAR TEMP PACING LEAD

FDA 510(k)

FDA Class 2 ·Cardiovascular

PERSONAL CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

KM-2 METAL-BACKED ACETABULAR CUP

FDA 510(k)

FDA Class 2 ·Orthopedic

Luja Coudé (20118 Male CH8 - small packaging (Pocket size)), Luja Coudé (20111 Male CH10 - small packaging (Pocket size)), Luja Coudé (20112 Male CH12 - small packaging (Pocket size)), Luja Coudé (20114 Male CH14 - small packaging (Pocket size)), Luja Coudé (20101 Male CH10 - large packaging), Luja Coudé (20102 Male CH12 - large packaging), Luja Coudé (20104 Male CH14 - large packaging), Luja Coudé (20106 Male CH16 - large packaging)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ANGIOJET ULTRA DVX THROMBECTOMY SET

FDA 510(k)

FDA Class 2 ·Cardiovascular

PORT-A-CATH LOW-PROFILE IMPLANTABLE ACCESS SYSTEMS

FDA 510(k)

FDA Class 2 ·General Hospital