CoverScan (CoverScan v1.1)

FDA 510(k)

FDA Class 2 ·Radiology

CAPTIA(R) SYPHILIS M, MODIFICATION

FDA 510(k)

FDA Class 2 ·Microbiology

MINITAPE URETHRAL SLING

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AUTOSTAT II ANTI-MYELOPEROXIDASE (MPO) ELISA

FDA 510(k)

FDA Class 2 ·Immunology

EQUIVITAL, MODEL EQ-01

FDA 510(k)

FDA Class 2 ·Cardiovascular

VASCUTEK COBRAHOOD EPTFE VASCULAR GRAFTS

FDA 510(k)

FDA Class 2 ·Cardiovascular

FORTOSS-CEMA

FDA 510(k)

FDA Class 2 ·Dental

CLEARVIEW HCG

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

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