ClearGuard HD Antimicrobial Barrier Cap

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CLEARGUARD HD END CAP

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

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

FDA 510(k)

FDA Class 2 ·Cardiovascular

A1-A,A1-B,A1-ABP,A1-MBP,A1-Z,A6-A,A6-B,PEH PACE.

FDA 510(k)

FDA Class 2 ·Cardiovascular

Hemodialysis Catheter Luer End Cap

FDA classification

FDA Class 2 ·Hemodialysis Catheter Luer End Cap

BLACHLY BITE BLOK & CHEEK FILLER

FDA 510(k)

FDA Class 2 ·Neurology

PHOTON RADIOSURGERY SYSTEM PRS400

FDA 510(k)

FDA Class 2 ·Radiology

CIRCON AEH-4 ELECTROHYDRAULIC LITHOTRIPSY PROBE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SEKURE Acetaminophen L3K Assay

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

SEKURE HbA1c Assay

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

YOUNG-HEALTH SUPER EAR THERMOMETER

FDA 510(k)

FDA Class 2 ·General Hospital

TANDEMHEART FEMORAL VENOUS CANNULA SET

FDA 510(k)

FDA Class 2 ·Cardiovascular

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·USCI(R)SOLITAIRE(TM) BALL.DIL.CATH.W/PRO/PEL(TM)

DYNAMESH -CICAT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AEH-3 ELECTROHYDRAULIC LITHOTRIPTER AND PROBES (E-1F, E-3F, E-5F, AND E-9F)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·USCI(R) SILK(TM)/AGIL(TM) BALL.DIL.CATH. W/PRO/PEL

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·USCI(R) SILK(TM)/AGIL(TM) BALL.DIL.CATH. W/PRO/PEL

HUMAPEN LUXURA HD

FDA 510(k)

FDA Class 2 ·General Hospital

MEDPOR OCULAR SCREW AND ACCEOSSORIES

FDA 510(k)

FDA Class 2 ·Ophthalmic

PERRY-KOLBERG (PK) TITANIUM MOTILITY/SUPPORT SYSTEM

FDA 510(k)

FDA Class 2 ·Ophthalmic