M22 and ResurFx Systems

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

OSS-BODIES PROXIMAL TIBIAL SLEEVE

FDA 510(k)

FDA Class 2 ·Orthopedic

SCLERAL PLUGS, 19 AND 20 GAUGE

FDA 510(k)

FDA Class 2 ·Ophthalmic

ATRION NEEDLEVISE LARGE-BORE SHARPS SECURING DEVICE

FDA 510(k)

FDA Class 2 ·General Hospital

MODIFICATION TO G2 FILTER SYSTEM-FEMORAL DELIVERY KIT, MODEL RF-310F

FDA 510(k)

FDA Class 2 ·Cardiovascular

ATI(R) DISP BIOLOGICAL-PLUS TEST PACK

FDA 510(k)

FDA Class 2 ·General Hospital

ELECSYS CA 19-9 CALCHECK 5

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

PERSONAL DEFIBRILLATOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

OLYMPUS XBF-UC180F-DT8 ULTRASONIC BRONCHOFIBERVIDEOSCOPE USED WITH ALOKA SSD-ALPHA 5/10 ULTRASOUND SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

4.5F IMAGECATH CORONARY ANGIOSCOPE, MODEL COV45 [SUBSEQUENTLY REFERRED TO AS THE MODIFIED ANGIOSCOPE[

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODIFICATION TO:ROCHE DIAGNOSTICS TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

FILTERED EXTENSION SETS

FDA 510(k)

FDA Class 2 ·General Hospital

2MM PEDIATRIC FLEX NAIL

FDA 510(k)

FDA Class 2 ·Orthopedic

TBD ETHICON MESH

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LEKSELL SURGIPLAN WITH IMAGEMERGE

FDA 510(k)

FDA Class 2 ·Neurology

MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MB

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SARNS ULTRASONIC AIR SENSOR

FDA 510(k)

FDA Class 2 ·Cardiovascular

GE ECHOPAC

FDA 510(k)

FDA Class 2 ·Radiology

EVIS EXERA 180 SYSTEM

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

SARNS OXYGENATOR SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular