Comaneci, Comaneci Petit, Comaneci 17

FDA 510(k)

FDA Class 2 ·Neurology

FRACTORA

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

RAPID Web

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CAPNOSTREAM20 TWO PARAMETER BEDSIDE MONITOR & CAPNOSTREAM10 ONE PARAMETER BEDSIDE MONITOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

Geneo X Elite

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MORPHEUS 1, AUTOMATED SLEEP STUDY SCORING & DATA MANAGEMENT SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

DIASTAT VASCULAR ACCESS GRAFT

FDA 510(k)

FDA Class 2 ·Cardiovascular

ReDs Wearable System

FDA 510(k)

FDA Class 2 ·Cardiovascular

PEERSCOPE SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PillCam Patency System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

R&G Surgical Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Disposable medical surgical mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5), OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5R), LIGHT GUIDE ADAPTER (MAJ-1413)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

KREATIV MACH 5, MACH 5 PLUS, MACH M, MACH 6

FDA 510(k)

FDA Class 2 ·Dental

WLP SEQUENTIAL VERSION MODEL WLP SOLO VI, WLP SOLO SEQUENTIAL

FDA 510(k)

FDA Class 2 ·Cardiovascular

Rugged Oxygen Generator (ROG) (RO01-00001)

FDA 510(k)

FDA Class 2 ·Anesthesiology

WONDFO MULTI-DRUG URINE TEST CUP MODEL W2002-CU; W2003-CU; W2004-CU; W2005-CU; W2006-CU; W2007-CU; W2008-CU; W2009-CU;

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

KidneyIntelX.dkd

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TSRH SPINAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

NeoSpan Compression Staple Impant w/instruments

FDA 510(k)

FDA Class 2 ·Orthopedic