MAGNUM PLUS LATEX CONDOM W/SPERMICIDAL LUBRICANT

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

WELKINS EMT/ICU TEMPERATURE MANAGERMENT SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

Proxima

FDA 510(k)

FDA Class 2 ·Anesthesiology

Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional

FDA 510(k)

FDA Class 2 ·Orthopedic

SmartCeph

FDA 510(k)

FDA Class 2 ·Radiology

Remedy® Shoulder Spacer

FDA 510(k)

FDA Class 2 ·Orthopedic

CuattroDR

FDA 510(k)

FDA Class 2 ·Radiology

SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial Implant

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SonoStik IV Guide Wire Introducer

FDA 510(k)

FDA Class 2 ·Cardiovascular

APRO 55 Intermediate Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

ALERTWATCH: OR

FDA 510(k)

FDA Class 2 ·Cardiovascular

VIDISTAR PACS & DICOM VIEWER SOFTWARE SERVER SOFTWARE SYSTEM, HEART VIEW, STANDALONE VIEWER

FDA 510(k)

FDA Class 2 ·Radiology

GRAMSORB SYNTHETIC ABSORBABLE SUTURE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Cobbra RF Tissue Dissector

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SCS CLARIS SPINAL SCREWS, TYPES V,G,E

FDA 510(k)

FDA Class 2 ·Orthopedic

CONGRUENT BONE PLATE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

AlertWatch: OR

FDA 510(k)

FDA Class 2 ·Cardiovascular

MH1 MICROHOLTER RECORDER

FDA 510(k)

FDA Class 2 ·Cardiovascular

ZAVATION SPINAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat