ICIS View

FDA 510(k)

FDA Class 2 ·Radiology

ICY CATHETER, MODEL IC-3893A

FDA 510(k)

FDA Class 2 ·Cardiovascular

SKIN CLIP SYSTEM, DISPOSABLE (AVLOX ICI)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

INTERPORE CROSS INTERNATIONAL (ICI) OCCIPITO-CERVICO-THORACIC (OCT) ROD AND PLATE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

COOL LINE CATHETER, MODEL CL-2295A, ICY CATHETER, MODEL IC-3893A AND QUATTRO CATHETER, MODEL IC-4593

FDA 510(k)

FDA Class 2 ·Cardiovascular

Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

COOL LINE CATHETER KIT, MODELS CL-2085B, CL-2295A; ICY CATHETER KIT, MODEL IC-3585A; FORTIUS CATHETER KIT, MOD. FR-5093B

FDA 510(k)

FDA Class 2 ·Cardiovascular

Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard XP Console, Thermogard HQ Console

FDA 510(k)

FDA Class 2 ·Cardiovascular

Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Start-Up Kit, Coolgard 3000 Console, Thermogard XP Console

FDA 510(k)

FDA Class 2 ·Cardiovascular

Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard HQ Start-Up Kit, Thermogard HQ Start-Up Kit EX, Thermogard HQ Console

FDA 510(k)

FDA Class 2 ·Cardiovascular

PERSONAL HEALTH CENTER (PHC)

FDA 510(k)

FDA Class 2 ·Cardiovascular

ACIES

FDA 510(k)

FDA Class 2 ·Radiology

BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602 Sizer Kit, BCI 602 Lifts (1mm)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

BCI WW1021 PC APPLICATION

FDA 510(k)

FDA Class 2 ·Cardiovascular

BCI WW1030 PULSE OXIMETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

BCI 3180 PULSE OXIMETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

SHARPS CONTAINER 18 GALLON

FDA 510(k)

FDA Class 2 ·General Hospital

FLEXO DENTAL RESIN MATERIAL

FDA 510(k)

FDA Class 2 ·Dental

IRRIGATOR, BODY CAVITY

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology