EXL-12SP,12DP,15DP,20DP LINAC

FDA 510(k)

FDA Class 2 ·Radiology

MECRON FEMORAL HEAD W/CONE AS UNIPOLAR OR BIPOLAR

FDA 510(k)

FDA Class 2 ·Orthopedic

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·COBAS AMPLIPREP / COBAS TAQMAN HCV TEST

MODEL EB-22 NOISE STIK

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

CO 2 SURGICAL LASER SYSTEM NA-30

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

THE SIDEWINDER 40CC DL INTRA-AORTIC BALLOON CATH.

FDA 510(k)

FDA Class 2 ·Cardiovascular

THORA-KLEX CHEST DRAINAGE UNIT

FDA 510(k)

FDA Class 2 ·General Hospital

OXYCON PRO

FDA 510(k)

FDA Class 2 ·Anesthesiology

MODIFICATION TO THE OXYCONALPHA

FDA 510(k)

FDA Class 2 ·Anesthesiology

CO 2 SURGICAL LASER SYSTEM MODEL NA-40

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LARGE TIP (4MM) DIAGNOSTIC-ELECTROHYSIOLOGY CATHETERS

FDA 510(k)

FDA Class 2 ·Cardiovascular

MEDINOL X-SUIT NIR BILIARY METALLIC STENT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DRAINAGE CATHETERS W/A DISSOLVABLE TIP

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DOWD CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

OXYCON-ALPHA

FDA 510(k)

FDA Class 2 ·Anesthesiology

MODIFIED TRANSLUMINAL BALLOON DILATATION CATHETERS

FDA 510(k)

FDA Class 2 ·Cardiovascular

LAPAROSCOPIC ASPIRATION PROBE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

MODIFIED PROSTATIC URETHROPLASTY BALLOON CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Monoject™ Enteral Syringe with ENFit Connector (401SE); Monoject™ Enteral Syringe with ENFit Connector (403SE); Monoject™ Enteral Syringe with ENFit Connector (406SE); Monoject™ Enteral Syringe with ENFit Connector (412SE); Monoject™ Enteral Syringe with ENFit Connector (435SE); Monoject™ Enteral Syringe with ENFit Connector (460SE)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CO 2 SURGICAL LASER SYSTEM NA-120

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery