TOTAL KNEE PROSTHESIS-NONCONSTRAINED

FDA 510(k)

FDA Class 2 ·Orthopedic

AFFIRM ONE-STEP HOME PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MODELS ERA 300 AND 3105 PACING SYSTEM ANALYZERS

FDA 510(k)

FDA Class 2 ·Cardiovascular

Selectra 3D Lead Delivery System (443624-443629, 451789-451791); Selectra Slitter Tool (383119); Selectra Accessory Kit (375518)

FDA 510(k)

FDA Class 2 ·Cardiovascular

ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE MICROPLATE REAGENT KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MICROPAQ, MODELS 402, 404

FDA 510(k)

FDA Class 2 ·Cardiovascular

ORTHOFIBER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ACUMED ANATOMIC RADIAL HEAD SYSTEM, ACUMED ANATOMIC RADIAL HEAD LONG STEMS, ACUMED ARH SLIDE-LOC

FDA 510(k)

FDA Class 2 ·Orthopedic

ORTHODONTIC. PLASTIC BRACKET PRIMER

FDA 510(k)

FDA Class 2 ·Dental

GLU(GOD) REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

THE VAULT

FDA 510(k)

FDA Class 2 ·General Hospital

Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYSTEM W/SINGLE NEEDLE SINGLE LUMEN OPTION

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

INNOFLUOR(TM) DIGITOXIN REAGENT SET

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

MODIFICATION TO VSM- VITAL SIGNS MONITOR, (VSM 300 )

FDA 510(k)

FDA Class 2 ·Cardiovascular

ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size Medium

FDA 510(k)

FDA Class 2 ·Neurology

ASTORIA-PACIFIC SPOTCHECK G6PD KIT 50 HR, MODEL 80-3000-13K

FDA 510(k)

FDA Class 2 ·Hematology

ARC SURGICAL BIOTRAK SCREW

FDA 510(k)

FDA Class 2 ·Orthopedic

OREGON FIXATION SCREW

FDA 510(k)

FDA Class 2 ·Orthopedic