POLYSCOPE FLEXIBLE ENDOSCOPY CATHETER; 10,000 PIXEL FIBER OPTIC; XENON LIGHT SOURCE, MODEL LS-200

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

SCANDINAVIAN IVF SCIENCES AB, SPERMRINSE -20/100

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SCANDINAVIAN IVF SCIENCES AB, FREEZE-KIT 1

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Gx-IVF, Gx-TL, Gx-MOPS PLUS

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SCANDINAVIAN IVF SCIENCES AB, THAW-KIT 1

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

BIOGENICS BIOQUAD 4-WELL IVF CULTURE DISH

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

JMS SYSLOC MINI AVF AND APHERESIS NEEDLE SETS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

TRS CRANIAL BONE VOID FILLER(TRS C-BVF)

FDA 510(k)

FDA Class 2 ·Neurology

PIONEER SURGICAL TECHNOLOGY NANOSS BVF-E, MODELS 5, 10, 20CC

FDA 510(k)

FDA Class 2 ·Orthopedic

Alzair Allergy Blocker

FDA 510(k)

FDA Class 2 ·General Hospital

AllerBlock Junior

FDA 510(k)

FDA Class 2 ·General Hospital

NextDent Denture, E-Denture

FDA 510(k)

FDA Class 2 ·Dental

Guardia Access Embryo Transfer Catheter Sets and Sydney IVF® Transfer Catheter

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

COOK SYDNEY IVF BLASTOCYST VITRIFICATION (K-SIBV-5000), WARMING (K-SIBW-5000) KITS

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Assay, Genotyping, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·Versant HCV Genotype 2.0 Assay (LiPA)

Assay, Genotyping, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, URACIL-N-GLYCOSYLASE (UNG)

Assay, Genotyping, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·VERSANT HCV Genotype 2.0 Assay (LiPA)

Assay, Genotyping, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·Abbott Real Time HCV Genotype II Amplification Reagent Kit / HCV Genotype II Control Kit

Assay, Genotyping, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, ABBOTT MSAMPLE PREPARATION SYSTEM

Assay, Genotyping, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT REAL TIME HCV GENOTYPE II, GENOTYPE II CONTROL KIT, ABBOTT MSAMPLE PREPARATION SYSTEM