OWENS CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

LEO III TX/RX QUADRATURE KNEE COIL; ALPHA III TX/RX QUADRATURE WRIST COIL

FDA 510(k)

FDA Class 2 ·Radiology

AMEDICA DRUG TEST THC, COC, OPI, AMP, MET, PCP, BAR, BZO, MDMA, OXY, TCA

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

QUICKTOX MULTIPLE DRUG DIPCARD COC/MET/THC/AMP/PCP/BZO/BAR/MTD/TCA, MODEL QT61

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

AMEDICA DRUG SCREEN THC, COC,OPI,AMP,MET,PCP,MDMA,BAR,BZO,; MODEL C1010,C1015,C1020

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

AMEDICA DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA, BAR, BZO, M, MODELS C1210, C1220

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

MODIFICATION TO: ACCUSIGN RC DOA 10 (MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

SMARTSAT PULSE OXIMETRY ANALYZER

FDA 510(k)

FDA Class 2 ·Cardiovascular

BIONEXA SINGLE AND MULTI-STRIP CASSETTE/DIPSTICK DOA SCREEN PANELS ( AMP, BAR, BZO, COC, MET, MTD, MOR, PCP, TCA, THC,

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

KARL STORZ KNIVES, CURETTES

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

KARL STORZ ENDOSCOPIC COLD KNIFE BLADES

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

FLEXIBLE AND RIGID URETEROTOME SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

OES UROLOGY

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

URETHROTOME 8667.XXX AND 8670.XXX

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ACCUSIGN DOA 10, ACCUSIGN DOA 10 PANEL, ACUSIGN MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP, BIOSIGN DOA10, BIOSIGN MET/OPI/

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ACCUSIGN DOA 10,ACCUSIGN DOA PANEL,ACCUSIGN MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP,BIOSIGN DOA 10, BIOSIGN MET/OPI/COC/

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Azo Dye, Calcium

FDA classification

FDA Class 2 ·Azo Dye, Calcium

ACCUSIGN DOA 8, ACCUSIGN DOA 8 PANEL, ACCUSIGN THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA 8, BIOSIGN THC/OPI/COC/AMP/P

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Motif Aura Glow breast pump (Model Motif Aura Glow)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular