MODIFICATION TO ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, PEG SAFETY KIT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Catheter Insertion Kit (K2-90); Cure Catheter Insertion Kit (K3); Cure Hydrophilic Catheter Kit (HM12UK); Cure Hydrophilic Catheter Kit (HM14UK); Cure Hydrophilic Catheter Kit (HM16UK); Cure Pocket Catheter Kit (M14UK); Cure Catheter Closed System Kit (CS8); Cure Catheter Closed System Kit (CS10); Cure Catheter Closed System Kit (CS12); Cure Catheter Closed System Kit (CS14); Cure Catheter Closed System Kit (CS14C

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

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

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT REAL TIME HCV ASSAY, ABBOTT REAL TIME HCV CALIBRATOR KIT AND CONTROL KIT, ABBOTT MSAMPLE PREPARATION SYSTEM

DIRECTFLOW KIT, 24 FR, SOFTCLAMP KIT, 24FR, STRAIGHTSHOT KIT, 23 FR, STRAIGHT TIP, STRAIGHTSHOT KIT, 23 FR, ANGLED TIP

FDA 510(k)

FDA Class 2 ·Cardiovascular

GLOBAL DMSO BLASTOCYST VITRIFICATION KIT AND WARMING KIT

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Stimulator, Stimulator Kit, External Transmitter, External Transmitter Kit

FDA 510(k)

FDA Class 2 ·Neurology

STRYKER DROP APPLICATOR, KITS, SPRAY APPLICATOR KIT, TIPS

FDA 510(k)

FDA Class 2 ·General Hospital

STEALTH PILOT KIT/ STEALTH SPACER/FACE MASK KIT

FDA 510(k)

FDA Class 2 ·Anesthesiology

INFRA VISION BOUGIE KIT, INFRA VISION ESOPHAGEAL KIT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PLEURX PERITONEAL CATHETER KIT AND PLEURX DRAINAGE KITS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ESWALLOW DYSPHAGIA THERAPY KIT, PMI DYSPHAGIA THERAPY KIT

FDA 510(k)

FDA Class 2 ·Physical Medicine

EUROIMMUN PR3 ELISA KIT. EUROIMMUN MPO ELISA KIT.

FDA 510(k)

FDA Class 2 ·Immunology

Sydney IVF Cryopreservation Kit, Sydney IVF Thawing Kit

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

THERMOGENESIS DROP APPLICATOR, KITS, SPRAY KITS AND TIPS

FDA 510(k)

FDA Class 2 ·General Hospital

SAGE Vitrification Kit and SAGE Vitrification Warming Kit

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SCIMED ENCORE ADVANTAGE KIT AND THE ESSENTIALS KIT

FDA 510(k)

FDA Class 2 ·Cardiovascular

TOTAL T3-RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

COAT-A-COUNT NEONATAL T4 KIT RIA KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ELECSYS ANTI-HCV ON MODULAR ANALYTICS E170

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

FDA Pre-Market Approval

FDA Class 2 ·COBAS AMPLICOR HCV TEST, VERSION 2.0 AND COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST, VERSION 2.0