Optilite High Sensitivity C-Reactive Protein Kit

FDA 510(k)

FDA Class 2 ·Immunology

LOGIC LAPAROSCOPIC INSTRUMENT SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SET, MODELS AB400-10, AB400-12, AB400-14

FDA 510(k)

FDA Class 2 ·Anesthesiology

DOUBLEPLAY SUTURE ANCHOR

FDA 510(k)

FDA Class 2 ·Orthopedic

PNEUPAC PARAPAC PLUS

FDA 510(k)

FDA Class 2 ·Anesthesiology

Brainomix 360 Triage LVO

FDA 510(k)

FDA Class 2 ·Radiology

EchoGo Core (2.0)

FDA 510(k)

FDA Class 2 ·Radiology

ACCULIS ACCU21 PMTA MICROWAVE TISSUE ABLATION APPLICATOR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SUPRAPUBIC CATHETER AND INTRODUCER SET

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SINGH SPEECH SYSTEM (SERIES 'SSS')

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

IDS-ISYS INTACT PTH

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

OSTEOBOOST-BMA

FDA 510(k)

FDA Class 2 ·General Hospital

GRAFTLOCK SCREW, ST SCREW

FDA 510(k)

FDA Class 2 ·Orthopedic

SIGMA ELITE

FDA 510(k)

FDA Class 2 ·Anesthesiology

Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda Kit

FDA 510(k)

FDA Class 2 ·Immunology

OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon A) Daily Wear Contact Lens

FDA 510(k)

FDA Class 2 ·Ophthalmic

STAR Apollo Mapping System

FDA 510(k)

FDA Class 2 ·Cardiovascular

Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Catheter Insertion Kit (K2-90); Cure Catheter Insertion Kit (K3); Cure Hydrophilic Catheter Kit (HM12UK); Cure Hydrophilic Catheter Kit (HM14UK); Cure Hydrophilic Catheter Kit (HM16UK); Cure Pocket Catheter Kit (M14UK); Cure Catheter Closed System Kit (CS8); Cure Catheter Closed System Kit (CS10); Cure Catheter Closed System Kit (CS12); Cure Catheter Closed System Kit (CS14); Cure Catheter Closed System Kit (CS14C

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SMART TENS, MODEL: D-BC05T

FDA 510(k)

FDA Class 2 ·Neurology

OptosAdvance 4.0 Software

FDA 510(k)

FDA Class 2 ·Radiology