Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ASSORTED MOD. C LOOPS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ASSORTED MOD. C LOOPS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC(R) MODELS 9710/9710A ,MOD.2038 MODIFICAT

Tissue Graft Of 6mm And Greater

FDA Pre-Market Approval

FDA Class 3 ·DARDIK BIOGRAFT(R) MOD. HUMAN UMBILICAL VEIN GRAFT

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL P-17 MOD. C LOOP W/NOTCH POSTERIOR CHAMBER

MICROTHIN-D1 (MOD. 0620)

FDA 510(k)

FDA Class 3 ·Cardiovascular

MICROTHIN-P1 (MOD. 0622)

FDA 510(k)

FDA Class 3 ·Cardiovascular

MOD TARGET/TIPS # 4011,4012,4511,4512,6912,4016

FDA 510(k)

FDA Class 3 ·Cardiovascular

OMNI-STANICOR (THETA) MOD 237A

FDA 510(k)

FDA Class 3 ·Cardiovascular

ENDOCARDIAL LEADS-MOD. TO THE POLYVINYLPYRROLIDONE

FDA 510(k)

FDA Class 3 ·Cardiovascular

LIFELINE BIPOLAR PACING LEAD MOD. 466-01

FDA 510(k)

FDA Class 3 ·Cardiovascular

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ESSENTIO Models L100, L101, L121; PROPONENT Models L200, L201, L221; ACCOLADE Models L300, L301, L321; PROPONENT MRI Mod

IMPLANT PROGRAM CARDIAC PULSE GEN W/MOD SET SCREW

FDA 510(k)

FDA Class 3 ·Cardiovascular

IMPLANT ELECT LEAD MOD 30-404 USING POLYU 90 A

FDA 510(k)

FDA Class 3 ·Cardiovascular

IMPLANT ELECT LEAD, MOD 030-405 USING POLYU 90 A

FDA 510(k)

FDA Class 3 ·Cardiovascular

IMPLANT ELECT LEAD, MOD 30-403 USING POLYU 90 A

FDA 510(k)

FDA Class 3 ·Cardiovascular

MODIFY LABEL/PASYS & MOD 8316/17/18 IMPLAN PUL GEN

FDA 510(k)

FDA Class 3 ·Cardiovascular

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval

FDA Class 3 ·ELECSYS TOTAL PSA IMMUNOASSAY

Calibrator For Alpha-Fetoprotein In Mid-Pregnancy Maternal Serum

FDA Pre-Market Approval

FDA Class 3 ·AFP MID-PREGNANCY REFERENCE PREPARATION

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·MED-EL COCHLEAR IMPLANT SYSTEMS (COMBI40+, PULSARCI100, SONATATI100, MED-EL CONCERT, & MED-EL CONCERT PIN)