Suture, Surgical, Absorbable, Polydioxanone

FDA Pre-Market Approval

FDA Class 2 ·PDS II (POLYDIOXANOE) SUTURE DYED & UNDYED

Suture, Surgical, Absorbable, Polydioxanone

FDA Pre-Market Approval

FDA Class 2 ·PDS II (POLYDIOXANOE) SUTURE DYED & UNDYED

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·PAS CHAMPION(TM) CATHETER 30 MM LONG BALLOONS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·PROGRESSIVE ANGTIOPLASTY SYSTEMS (PAS) CHAMPION PTCA CORONARY DILATATION CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·EXTENSION TO THE PAS LACROSSE PTCA CATHETER PRODUCT LINE

Youha electric breast pumps (The INs, The INs Gen2, The INs NEXT, and P3) and BEBEBAO electric breast pump (P1s)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SPERTILITE PHOTOTHERAPY LAMP

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PROSTHETIC RINGS #4400 MITRAL & 4500

FDA 510(k)

FDA Class 2 ·Cardiovascular

DIASTAT VASCULAR ACCESS GRAFT

FDA 510(k)

FDA Class 2 ·Cardiovascular

BK-N SEALING CAP

FDA 510(k)

FDA Class 2 ·Cardiovascular

A1-A,ABP,B,MBP, LEAD CONNECTORS; PEH ADAPTER SLEEVE

FDA 510(k)

FDA Class 2 ·Cardiovascular

AXILLOBIFEMORAL GORE-TEX CASCULAR GRAFT,BIFURCATED

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARPENTIER-EDWARDS FLEX. ANNULOPLASTY

FDA 510(k)

FDA Class 2 ·Cardiovascular

CORFLO 300 PUMP

FDA 510(k)

FDA Class 2 ·General Hospital

DIASTAT(TM) VASCULAR ACCESS GRAFT/CLASS III

FDA 510(k)

FDA Class 2 ·Cardiovascular

Auto-Antibodies; Phosphatidylserine, Prothrombin, Phosphatidylserine/Prothrombin Complex

FDA classification

FDA Class 2 ·Auto-Antibodies; Phosphatidylserine, Prothrombin, Phosphatidylserine/Prothrombin Complex

Enteral Specific Transition Connectors

FDA classification

FDA Class 2 ·Enteral Specific Transition Connectors

Enteral Syringes With Enteral Specific Connectors

FDA classification

FDA Class 2 ·Enteral Syringes With Enteral Specific Connectors