FAST SPIN ECHO (FSE)

FDA 510(k)

FDA Class 2 ·Radiology

Goldtrace Fetal Spiral Electrode (FSE) (CNS000004)

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SARA RT

FDA 510(k)

FDA Class 2 ·Anesthesiology

SARACAP RESPIRATORY MONITOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

SUNBRONZE TANNING LAMPS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PRE-CHECK C02 DETECTOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

Winback Back 3SE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SMART ECG SERIES ELECTROCARDIOGRAPH, MODELS SE-3, SE-300A AND 300B, SE-6, SE-600, SE-12, SE-12 EXPRESS AND SE-1200

FDA 510(k)

FDA Class 2 ·Cardiovascular

FSC ANTI-STATIC VALVED COLLAPSIBLE HOLDING CHAMBER

FDA 510(k)

FDA Class 2 ·Anesthesiology

PADLOCK CLIP-12

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

InActiv Blue

FDA 510(k)

FDA Class 2 ·Microbiology

FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicin

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

GETTIG STYRL-JECT DELIVERY SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·OPTECH FRE-FLEX SOFT CONTACT LENS

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·OPTECH FRE-FLEX SOFT CONTACT LENS

EMIT II PLUS6-ACETYLMORPHINE ASSAY; EMIT II PLUS 6-AM/ ECSTASY CALIBRATOR/ CONTROL LEVEL 1; EMIT II PLUS 6-AM / ECTASY C

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

BERICHROM HEPARIN LMW CALIBRATOR, BERICHROM HEPARIN LMW CONTROL 1, AND BERICHROM HEPARIN LMW CONTROL 2

FDA 510(k)

FDA Class 2 ·Hematology

BERICHROM HEPARIN UF CALIBRATOR, BERICHROM HEPARIN UF CONTROL 1, AND BERICHROM HEPARIN UF CONTROL 2

FDA 510(k)

FDA Class 2 ·Hematology

DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 6454

FDA 510(k)

FDA Class 2 ·Immunology

CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza B Lineage Genotyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/H5 Subtyping Kit

FDA 510(k)

FDA Class 2 ·Microbiology