TRIOS - M

FDA 510(k)

FDA Class 3 ·Cardiovascular

DNP 60-B UNIPOLAR ENDOCARDIAL LEAD

FDA 510(k)

FDA Class 3 ·Cardiovascular

LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD, DJP 60-UP

FDA 510(k)

FDA Class 3 ·Cardiovascular

NEOS-M PULSE GENERATOR

FDA 510(k)

FDA Class 3 ·Cardiovascular

AROX 53-BP; AROX 60-BP; AROX 45-JBP; AROX 53-JBP

FDA 510(k)

FDA Class 3 ·Cardiovascular

LABELING CHANGES TO PULSE GENE. & PULSE GENE. LEAD

FDA 510(k)

FDA Class 3 ·Cardiovascular

PACING LEADS, GUIDE WIRES, AND VARIOUS ACCESSORIES

FDA 510(k)

FDA Class 3 ·Cardiovascular

HEART*AID 1000

FDA 510(k)

FDA Class 3 ·Cardiovascular

ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BP

FDA 510(k)

FDA Class 3 ·Cardiovascular

HEARTSTART 3000

FDA 510(k)

FDA Class 3 ·Cardiovascular

RETROX RX 53-BP, RETROX RX 60-BP, RETROX RX 45-JBP, RETROX RX 53-JBP MODEL NUMBERS 124 396, 124 397, 124 395, 124 000

FDA 510(k)

FDA Class 3 ·Cardiovascular

NEOS VS-1, PULSE GENERATOR

FDA 510(k)

FDA Class 3 ·Cardiovascular

TRIOS-M VS-1 PULSE GENERATOR

FDA 510(k)

FDA Class 3 ·Cardiovascular

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS HBEAG REAGENT PACK/PRODUCTS HBEAG CALIBRATOR/PRODUCTS HBE CONTROLS

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBC REAGENT PACK & CALIBRATOR

MEDTRONIC MODEL 5867-1A

FDA 510(k)

FDA Class 3 ·Cardiovascular

UNIVERSAL TERMINAL CAP, 3.2MM

FDA 510(k)

FDA Class 3 ·Cardiovascular

IMPLANT AID SPLICING CRIMP & SLEEVE

FDA 510(k)

FDA Class 3 ·Cardiovascular

Stent, Urethral, Prostatic, Permanent Or Semi-Permanent

FDA Pre-Market Approval

FDA Class 3 ·UROLUME(TM)ENDOPROSTHESIS

Stent, Urethral, Bulbous, Permanent Or Semi-Permanent

FDA Pre-Market Approval

FDA Class 3 ·AMSUROLUME ENDOPROSTHESIS