SYSTEMATE CK-MB(NAC-ACTIVATED) ITEM NO. 67205

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CK-NAC REAGENT(CREATINE KINASE/N-ACETYL CYSTEINE)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MODIFICATION TO THE NAC PLUS NEEDLELESS ACCESS CONNECTOR

FDA 510(k)

FDA Class 2 ·General Hospital

CK-TOTAL/CK-B (NAC) BIOLUMIN. ASSAY KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CK-NAC 2-VIAL REAGENT W/SUBSTRATE START

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CK-NAC REAGENT CREATINE KINASE N-ACETYL CYSTEINE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Vertex Hip Fracture Nailing System

FDA 510(k)

FDA Class 2 ·Orthopedic

Solo+ Tympanostomy Tube Device (TTD)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Solo+ Tympanostomy Tube Device (TTD), Solo+ TTD, Solo+ (Solo+ Tympanostomy Tube Handpiece (Catalogue #: 12115-100-000) and Solo+ Tympanostomy Tube Cartridge (Catalogue #: 12115-200-000))

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Sharps Needle Destruction Device

FDA Pre-Market Approval

FDA Class 2 ·NIC 1800 NEEDLE DISPOSAL SYSTEM

SENSUA!

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

AWARE PAD

FDA 510(k)

FDA Class 2 ·Radiology

AUTONEB ACCESSORY CROSS (AAC)

FDA 510(k)

FDA Class 2 ·Anesthesiology

EROJECT, MINIJECT, SELF ASPIRATING SYRINGES, ASPIRATING SYRINGES, NON ASPIRATING SYRINGES

FDA 510(k)

FDA Class 2 ·Dental

AGILIS NXT STEERABLE INTRODUCER, MODEL G408324

FDA 510(k)

FDA Class 2 ·Cardiovascular

Impulse Angiographic Catheter, Expo Angiographic Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

EN CIRCLR AL ADJUSTABLE LOOP MAPPING CATHETER MODELS, 1045AL1, 1045AL2, 1060AL1, 1060AL2

FDA 510(k)

FDA Class 2 ·Cardiovascular

Specimen Bag, model: WEP040306B, WEP010304B, WEP040304B, WEP010759B, WEP010709B, WEP010304A, WEP010759A, WEP010709A

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

FREEDOM(R) STEMMED TIBIAL COMPONENTS

FDA 510(k)

FDA Class 2 ·Orthopedic

FREEDOM PCK COMPONENTS

FDA 510(k)

FDA Class 2 ·Orthopedic