PORTABLE INTENSIVE CARE UNIT

FDA 510(k)

FDA Class 3 ·Cardiovascular

AFP CARDIAC PACING SYSTEM MODEL 283 (MODIFICATION)

FDA 510(k)

FDA Class 3 ·Cardiovascular

AFP CARDIAC PACING SYSTEM MODEL 283

FDA 510(k)

FDA Class 3 ·Cardiovascular

LIFE SUPPORT FOR TRAUMA AND TRANSPORT

FDA 510(k)

FDA Class 3 ·Cardiovascular

PHILIPS M5066A AND M5068A

FDA 510(k)

FDA Class 3 ·Cardiovascular

MAXIM PF MODELS 033-581/033-590

FDA 510(k)

FDA Class 3 ·Cardiovascular

MINIX 834M & MINIX ST 8331M PULSE GENERATORS (MODIFICATION)

FDA 510(k)

FDA Class 3 ·Cardiovascular

TENDRIL, UNIPOLAR ENDOCARDIAL SCREW-IN LEAD

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

BIPLR IM EN PAC LEADS (430-07,432-03,436-02 & 07, 438-05 & 07)

FDA 510(k)

FDA Class 3 ·Cardiovascular

ZOLL M SERIES 12SL ANALYSIS OPTION

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

MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORS

FDA 510(k)

FDA Class 3 ·Cardiovascular

OPUS S MODEL 4121 AND 4124 PACEMAKERS

FDA 510(k)

FDA Class 3 ·Cardiovascular

DF-1 TERMINAL CAP

FDA 510(k)

FDA Class 3 ·Cardiovascular

JUMP START, MODEL 970300

FDA 510(k)

FDA Class 3 ·Cardiovascular

HEWLETT-PACKARD M2475B WITH 12-LEAD OPTION (#C90) CODEMASTER 100 CONITOR/DEFIBRILLATOR

FDA 510(k)

FDA Class 3 ·Cardiovascular

FIRSTSAVE BIPHASIC MODELS 9200 AND 9210

FDA 510(k)

FDA Class 3 ·Cardiovascular

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ENTOVIS DR, ENTOVIS DR-T, ENTOVIS SR, ENTOVIS SR-T, EVIA DR, EVIA DR-T, EVIA SR,EVIA SR-T, ESTELLA DR, ESTELLA DR-T, EST

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Edwards SAPIEN 3™ Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra™ Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra™