ICOR AGENT MONITOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

Ultra RapidWarm™ Blast

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

REDSENSE ALARM SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PRESSURE WIRE SENSOR, MODELS 12004/12304

FDA 510(k)

FDA Class 2 ·Cardiovascular

Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial Needle

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GUIDOR(TM)

FDA 510(k)

FDA Class 2 ·Dental

SBF 15 ESTHETIC ABUTMENT 1MM NP, MODEL 33699, SFB 15 ESTHETIC ABUTMENT 1MM RP, MODEL 33701, CFB 15 ESTHETIC ABUTMENT 2MM

FDA 510(k)

FDA Class 2 ·Dental

NOBEL ACTIVE 3.0

FDA 510(k)

FDA Class 2 ·Dental

EDTA CAVIT

FDA 510(k)

FDA Class 2 ·Dental

AMIKACIN

FDA 510(k)

FDA Class 2 ·Microbiology

NobelZygoma 0°

FDA 510(k)

FDA Class 2 ·Dental

COAMATE PROTEIN C CHROMOGENIC ASSAY

FDA 510(k)

FDA Class 2 ·Hematology

MEDSCAND DISPOSABLE PLASTIC VAGINAL SPECULUM; EASY-SPEC PLASTIC VAGINAL SPECULUM, MODEL 303

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ALTHIN MEDICAL AB ALTRACART II

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1

FDA 510(k)

FDA Class 2 ·Anesthesiology

Sectra Digital Pathology Module

FDA 510(k)

FDA Class 2 ·Pathology

Sentinel

FDA 510(k)

FDA Class 2 ·Radiology

PROVOX HME CASSETTE, MODEL 7240; PROVOX ADHESIVE, MODEL 7251

FDA 510(k)

FDA Class 2 ·Anesthesiology

MAMBA CONDOM (RUBBER LATEX)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

CERAMENT BONE VOID FILLER, MODEL A0210

FDA 510(k)

FDA Class 2 ·Orthopedic