MASKY

FDA 510(k)

FDA Class 2 ·Dental

MANAN SOFT TISSUE BIOPSY NEEDLES

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

COULTER BODY FLUID CONTROL

FDA 510(k)

FDA Class 2 ·Hematology

DEMETECH POLYESTER NONABSORBABLE SUTURE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SUREFIRE HI-FLOW MICROCATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

PACE 10 NON-INVASIVE EXTERNAL PACEMAKER

FDA 510(k)

FDA Class 2 ·Cardiovascular

INTERV BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MODIFICATION TO SMALL BONE FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Carnation Ambulatory Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM/ UNICEL DXH SLIDEMAKER STAINER COULTER CELLULAR ANALYSIS SYSTEM

FDA 510(k)

FDA Class 2 ·Hematology

300M ECG MONITRO/TRANSCUTANEOUS PACEMAKER

FDA 510(k)

FDA Class 2 ·Cardiovascular

Medline ReNewal Reprocessed Stryker Neptune 2 Manifolds

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DynaCAD

FDA 510(k)

FDA Class 2 ·Radiology

DxH 520 Hematology Instrument

FDA 510(k)

FDA Class 2 ·Hematology

UroNav (Version 3.0)

FDA 510(k)

FDA Class 2 ·Radiology

EXTENDED MEASUREMENTS SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

MEDISSISS REPROCESSEDENT ABLATION WANDS (COBLATORS), MODEL#EIC8872-01

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DENSEO FAIRY

FDA 510(k)

FDA Class 2 ·Dental

Syntheon LAA Exclusion System, Syntheon LAA Selection Guide

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CHEMWELL, ALSO KNOWN AS PROJECT 2900

FDA 510(k)

FDA Class 2 ·Clinical Chemistry