SPOTCHEM II INOGANIC PHOSPHORUS, CPK AND URIC ACID TESTS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Single Use Balloon Dilator V (with knife)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SPHINCTEROTOME

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GIP/MEDI-GLOBE PAPILLOTOME

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping Catheter

FDA 510(k)

FDA Class 2 ·Cardiovascular

ULTRA ZYME PLUS CK-1 #64978, 65027 & 28

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DAIG DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

ELECTRODE SEMI-FLOTATION CATHETER BY J-LLOYD MEDICAL, INC.

FDA 510(k)

FDA Class 2 ·Cardiovascular

CREATINE KINASE, N-ACETYL-L-CYSTIENE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

GYRO TIP EP CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

REFSTAR RMT EXTERNAL REFERENCE PATCH

FDA 510(k)

FDA Class 2 ·Cardiovascular

ULTRAZYME PLUS CK-I, #64978,65027&65028

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CORDIS WEBSTER T20 DIAGNOSTIC DEFLECTABLE TIP CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

CORDIS WEBSTER REF-STAR EX SURFACE REFERENCE DEVICE MODEL'S D-1204-01, -02,-03, AND -04.

FDA 510(k)

FDA Class 2 ·Cardiovascular

CHEM-STRATE CK-NAC

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SERUM, CREATININE PHOSPHOKINASE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VARIABLE LASSO NAV CATHETER, MODELS: D-1290-01, D-1290-02

FDA 510(k)

FDA Class 2 ·Cardiovascular

VISION CREATINE KINASE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

UNI-FAST CREATINE KINASE TEST (CK)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

OLYMPUS PK-TP SYSTEM REACTIVE CONTROL

FDA 510(k)

FDA Class 2 ·Microbiology