Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·PTCA CATHETERS

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·CUTTING BALLOON

POWER INJECTABLE IMPLANTABLE INFUSION PORT WITH SILICONE LUMEN (ATTACHABLE AND PRE-ATTACHED)

FDA 510(k)

FDA Class 2 ·General Hospital

New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded & Pre-Shaded)

FDA 510(k)

FDA Class 2 ·Dental

Sol-Care Safety Blood Collection Needle with and without Pre-Attached Holder

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PROWLER SELECT 10 AND 14 INFUSION CATHETERS WITH AND WITHOUT PRE-SHAPED TIPS

FDA 510(k)

FDA Class 2 ·Cardiovascular

BD PRE-FILLED HEPARIN LOCK FLUSH IN 0.9% SODIUM CHLORIDE INJECTION, USP SYRINGE

FDA 510(k)

FDA Class 2 ·General Hospital

KENDALL MONOJECT PRE-FILL ADVANCED 0.9%SODIUM CHLORIDE FLUSH SYRINGES FOR STERILE DELIVERY

FDA 510(k)

FDA Class 2 ·General Hospital

SSCOR/BOARD ..3 MODEL 23000 PRE-ASSEMBLED SUCTION SYSTEM FOR PATIENT TRANSPORT VEHICLES

FDA 510(k)

FDA Class 2 ·General Hospital

TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520

FDA 510(k)

FDA Class 2 ·Dental

GAME READY PROFESSIONAL THERAPY SYSTEM, MODEL 550100, GAME READY PRE-PROGRAMMED PROFESSIONAL THERAPY SYSTEM

FDA 510(k)

FDA Class 2 ·Physical Medicine

PROWLER SELECT (10, 14, AND PLUS) INFUSION CATHETERS WITH AND WITHOUT PRE-SHAPED TIPS

FDA 510(k)

FDA Class 2 ·Cardiovascular

MICRUS MICROCATHETER COURIER PRE-SHAPED, MODELS MPS170045-00, MPS170090-00, MPS190045-00, MPS190090-00

FDA 510(k)

FDA Class 2 ·Cardiovascular

Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010)

FDA 510(k)

FDA Class 2 ·General Hospital

IMPROSAFE Blood Collection Set with Pre-attached Holder, IMPROVACUTER Blood Collection Set Pre-attached Holder, IMPROSAFE Blood Collection Set, IMPROVACUTER Blood Collection Set, IMPROSAFE Multi Sample Needle, IMPROSAFE Multi Sample Needle (Flashback), IMPROVACUTER Multi Sample Needle

FDA 510(k)

FDA Class 2 ·General Hospital

DIGNITY MINI PORT- ATTACHABLE; DIGNITY MINI PORT- PRE ATTACHED; DIGNITY LOW PROFILE PORT- ATTACHABLE; DIGNITY LOW PROFIL

FDA 510(k)

FDA Class 2 ·General Hospital

FRESENIUS COMBILINES LOW VOLUME BLOOD TUBING SET, MODELS 03-2291 (POST PUMP) AND 03-2292 (PRE-PUMP)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODIFICATION TO MIXJECT DISPENSING PIN/WITH DETACHABLE VIAL HOLDER/WITH DETACHABLE VIAL HOLDER AND PRE-ATTACHED NEEDLE

FDA 510(k)

FDA Class 2 ·General Hospital

PRE-VACUUM AUTOCLAVE WITH STEAM GENERATOR AND VERTICAL SLIDING DOOR, MODELS 4472 EP-1V AND 5596 EP-1V

FDA 510(k)

FDA Class 2 ·General Hospital

REPOL ANGIMESH, ANGIMESH PRE, FOLDED MESH, REPOL PLUG BASIC, REPOL PLUG CAP, REPOL PLUG FLOWER AND WINGS MESH

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery