CEFDINIR, 5 UG, SENSI-DISC

FDA 510(k)

FDA Class 2 ·Microbiology

SnoreSounds

FDA 510(k)

FDA Class 2 ·Anesthesiology

SIASCOPE V

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

FLEXGARD SYRINGE PROTECTOR

FDA 510(k)

FDA Class 2 ·General Hospital

Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir, Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir with Xcoating, Terumo Capiox SX25 Oxygenator/Hardshell Reservoir, Terumo Capiox SX25 Oxygenator/Hardshell Reservoir with Xcoating

FDA 510(k)

FDA Class 2 ·Cardiovascular

QBC ACCUREAD SYSTEM

FDA 510(k)

FDA Class 2 ·Hematology

PULMOLAB EX671 EXERCISE TESTING SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

INTERCEPT ESOPHAGEAL INTERNAL MR COIL, INTERCEPT URETHRAL INTERNAL MR COIL, AND INTERCEPT VASCULAR INTERNAL MR COIL

FDA 510(k)

FDA Class 2 ·Radiology

MEDISYSTEMS BUTTONHOLE NEEDLE SETS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

AUTOLENS CLEANING AND DISINFECTING UNIT

FDA 510(k)

FDA Class 2 ·Ophthalmic

FOLATE REAGENT KIT, ARIA-II SYSTEM

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

EXSEPT SKIN AND WOUND CLEANSER WITH ANTIMICROBIAL PRESERVATIVE

FDA 510(k)

FDA Class 2 ·General Hospital

4CIS VANE SPINE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

CLEARPOINT SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

GELBFISH ENDO-VAC SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

BIOFIX ABSORBABLE SELF-REINFORCED POLY-L-LACTIDE

FDA 510(k)

FDA Class 2 ·Orthopedic

GEM KNEE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

RAICHEM CREATININE URINE STANDARD

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

NON-PVC FLUID PATH PORT ACCESS INFUSION SET (WITH AND WITHOUT INJECTION SET)

FDA 510(k)

FDA Class 2 ·General Hospital

AMERICANA HIP PROTHESIS

FDA 510(k)

FDA Class 2 ·Orthopedic