ADAC MODEL ARC-ST, PC STYLE DATA PROCESSING SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

MILEX CONTRACEPTIVE DIAPHRAGM, OMNIFLEX DIAPHRAGMS, ARCING DIAPHRAGMS, WIDESEAL DIAPHRAGMS

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Wrist Blood Pressure Monitor (OHMS11, OHMS12)

FDA 510(k)

FDA Class 2 ·Cardiovascular

MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System

FDA 510(k)

FDA Class 2 ·Cardiovascular

CRPEX-BR C-REACTIVE PROTEIN LIT ASSAY, CRPEX-BR CRP CALIBRATOR SET

FDA 510(k)

FDA Class 2 ·Immunology

BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) Application, BD Kiestra MRSA App

FDA 510(k)

FDA Class 2 ·Microbiology

STERILUCENT SELF-CONTAINED BIOLOGICAL INDICATOR

FDA 510(k)

FDA Class 2 ·General Hospital

VERIFY Incubator for Assert VH2O2 Self-Contained Biological Indicator

FDA 510(k)

FDA Class 2 ·General Hospital

Anprolene SteriTest RRBI

FDA 510(k)

FDA Class 2 ·General Hospital

SPOR-TEST-STRIP

FDA 510(k)

FDA Class 2 ·General Hospital

3M Attest Rapid Readout Biological Indicator

FDA 510(k)

FDA Class 2 ·General Hospital

MOBICATH TRANSSEPTAL NEEDLE

FDA 510(k)

FDA Class 2 ·Cardiovascular

ARROW-FISCHELL EXTENDED VASCULAR ACCESS NEEDLE

FDA 510(k)

FDA Class 2 ·Cardiovascular

CELERITY 20 HP Biological Indicator

FDA 510(k)

FDA Class 2 ·General Hospital

PathBuilder Transseptal Needle

FDA 510(k)

FDA Class 2 ·Cardiovascular

MOBICATH TRANSSEPTAL NEEDLE

FDA 510(k)

FDA Class 2 ·Cardiovascular

DANA REUSABLE TESTPACK FOR STEAM STERILIZATION FOR 10 MINUTE EXTENDED CYCLES

FDA 510(k)

FDA Class 2 ·General Hospital

VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR FOR VAPORIZED (VH2O2) STERILIZATION PROCESSES

FDA 510(k)

FDA Class 2 ·General Hospital

STERRAD 50/100S/200 TEST PACK

FDA 510(k)

FDA Class 2 ·General Hospital

STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader

FDA 510(k)

FDA Class 2 ·General Hospital