K-ASSAY D-DIMER, K-ASSAY D-DIMER CALIBRATOR, MODELS KAI-090; KAJ-091C

FDA 510(k)

FDA Class 2 ·Hematology

Remex KA6

FDA 510(k)

FDA Class 2 ·Radiology

T-METER

FDA 510(k)

FDA Class 2 ·Neurology

IRRIS (Infra-Red-Red Intubation System)

FDA 510(k)

FDA Class 2 ·Anesthesiology

LapBox Power Tissue Containment System

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

KAI SENSORS NON-CONTACT RESPIRATORY RATE SPOT CHECK, MODEL 100, KAI RSPOT, MODEL 100

FDA 510(k)

FDA Class 2 ·Anesthesiology

CU-75 VISIBLE LIGHT-CURING UNIT

FDA 510(k)

FDA Class 2 ·Dental

KAI SPOT MODEL KMS 200

FDA 510(k)

FDA Class 2 ·Anesthesiology

MASKS SURGICAL DENTAL

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Minjie Catheter System

FDA 510(k)

FDA Class 2 ·Cardiovascular

ViaOne Epicardial Access System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Flosteril Poly-reinforced Isolation Gowns Model 8120 (Catalogue Number 8120400), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120410), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120430), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120450), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120460)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C)

FDA 510(k)

FDA Class 2 ·Neurology

GMK Sphere

FDA 510(k)

FDA Class 2 ·Orthopedic

GMK Sphere Revision

FDA 510(k)

FDA Class 2 ·Orthopedic

MectaTap TI Suture Anchor

FDA 510(k)

FDA Class 2 ·Orthopedic

MectaLock All-Suture Anchors

FDA 510(k)

FDA Class 2 ·Orthopedic

M-ARS ACL: Anatomic Ribbon Surgery System

FDA 510(k)

FDA Class 2 ·Orthopedic

Advanced MyHip Planner

FDA 510(k)

FDA Class 2 ·Radiology

EXALIS, SOFTWARE VERSION 1.15

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology