NIDEK MULTICOLOR LASER PHOTOCOAGULATOR

FDA 510(k)

FDA Class 2 ·Ophthalmic

REP(TM) LD-2 STAT KIT, CAT. NO. 3078

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

THOR HENOSTATSIS ANALYZER CAT. NO. 1450, 1451

FDA 510(k)

FDA Class 2 ·Hematology

OMNIFIT CONSTRAINED ACETABULAR BEARING INSERT

FDA 510(k)

FDA Class 2 ·Orthopedic

GLYCO-TEK AFFINITY COLUMN KIT

FDA 510(k)

FDA Class 2 ·Hematology

APTT-ES

FDA 510(k)

FDA Class 2 ·Hematology

TITAN GEL IMMUNOFIX-9 CAT. NO. 3051 AND 3067

FDA 510(k)

FDA Class 2 ·Immunology

LABILE LYSING REAGENT

FDA 510(k)

FDA Class 2 ·Hematology

MODIFICATION COLUMNMATE

FDA 510(k)

FDA Class 2 ·Hematology

COLOSCREEN-ES

FDA 510(k)

FDA Class 2 ·Hematology

REP IMMUNOFIX

FDA 510(k)

FDA Class 2 ·Immunology

REP(R) IMMUNOFIX

FDA 510(k)

FDA Class 2 ·Immunology

Catheter, Angioplasty, Peripheral, Transluminal

FDA Pre-Market Approval

FDA Class 2 ·FLEXTOME CUTTING BALLOON MONORAIL(MR)/OVER THE WIRE(OTW)

Catheter, Angioplasty, Peripheral, Transluminal

FDA Pre-Market Approval

FDA Class 2 ·ULTRA2 CUTTING BALLOON MONORAIL(MR)

Catheter, Angioplasty, Peripheral, Transluminal

FDA Pre-Market Approval

FDA Class 2 ·CUTTING BALLOON MONORAIL(MR)/OVER THE WIRE(OTW)

QUEST VEIN GRAFT PERFUSION SET

FDA 510(k)

FDA Class 2 ·Cardiovascular

AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH BALANCE BIOSURFACE, AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH CARMEDA BIOACTIVE

FDA 510(k)

FDA Class 2 ·Cardiovascular

SCIMED GATEWAY PLUS

FDA 510(k)

FDA Class 2 ·Cardiovascular

OXYGENATOR HOLDER

FDA 510(k)

FDA Class 2 ·Cardiovascular

LARGE LUMEN Y ADAPTER W/ROTATING DEVICE

FDA 510(k)

FDA Class 2 ·Cardiovascular