7F ACUMEN CORONARY SINUS VISUALIZATION SYSTEM, MODEL CSVS-7-67

FDA 510(k)

FDA Class 2 ·Cardiovascular

ALARA IMAGING SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

ACUMEN INSIGHT ENDOCARDIAL VISUALIZATION SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-10, BLS-9, BLS-7

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACUMEN LEAD DELIVERY SHEATH WITH STYLET, MODELS LDS-10-64-STY AND LDS-10-57-STY

FDA 510(k)

FDA Class 2 ·Cardiovascular

ULTRACINCH ABLATION DEVICE, ULTRACINCH ACCESSORY PACK, MODELS UC-8, UC-9, UC-10, UC-11, UC-12, UC-13, UC-14, UC-ACC-1

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ACUMEN SINGLE-LUMEN DELIVERY SHEATH

FDA 510(k)

FDA Class 2 ·Cardiovascular

THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPE SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

THIRD EYE PANORAMIC AUXILIARY ENDOSCOPY SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

EPICOR ABLATION CONTROL SYSTEM, MODEL ACS-US-2, ACS-EUR-2

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

EPICOR MEDICAL ABLATION SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODIFIED ACUMEN LEAD DELIVERY SHEATH WITH STYLET, MODEL: SPIRIT-10.5-59

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION TO THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODIFIED ACUMEN LEAD DELIVERY SHEATH, MODELS LDS-10-57, LDS-10-57-90, LDS-10-64 AND LDS-10-64-90

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-8-45, BLS-7-45, BLS-6-45

FDA 510(k)

FDA Class 2 ·Cardiovascular

NOVA 4 NA/K/C1/TCO2/LI ANALYZER

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ACCUSTEP DOA SINGLE AND MULTI-STRIP SCREEN PANELS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

BIONEXIA HCG PREGNANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS, MODELS 08-HCGC AND 02-HCGC

FDA 510(k)

FDA Class 2 ·Clinical Chemistry