FIAGEN TBG TIME-RESOLVED FLUOROIMMUNOASSAY KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CYBERFLUOR FIAGEN TSH

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

FLAGEN TRIIODOTHYRONINE (T3) ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Monitor, Carbon-Dioxide, Cutaneous

FDA Pre-Market Approval

FDA Class 2 ·MODEL 515 NEONATAL MONIOTR

ULTRASONIC PACHYMETER

FDA 510(k)

FDA Class 2 ·Radiology

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·NDS LENS MAINTENANCE SYSTEM

ETP 180 CARDIAC PACEMAKER (EXTERNAL)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Full Field Digital, System, X-Ray, Mammographic

FDA Pre-Market Approval

FDA Class 2 ·SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

Tissue Adhesive For The Topical Approximation Of Skin

FDA Pre-Market Approval

FDA Class 2 ·INDERMIL TISSUE ADHESIVE

WALLACE OOCYTE RETRIEVAL SETS 16G, WALLACE OOCYTE RETRIEVAL SET 17G, MODELS MEONS 1633S, MEONS 1733S

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

PORTEX EMERGENCY CRICOTHYROIDOTOMY KIT

FDA 510(k)

FDA Class 2 ·Anesthesiology

PORTEX RING PESSARY PVC-NON STERILE; PORTEX RING PESSARY POLYTHENE- NON STERILE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

PORTEX ULTRAPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT_WITH SERIAL DILATORS OR SINGLE STAGE DILATOR, BLUE LINE ULTRA

FDA 510(k)

FDA Class 2 ·Anesthesiology

PORTEX THERMOVENT HEPA HME BREATHING FILTER WITH CO2 PORT (STERILE AND NON-STERILE)

FDA 510(k)

FDA Class 2 ·Anesthesiology

SURESAMPLE-WALLACE ENDOMETRIAL SAMPLER, ENDO 26

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Access PCT

FDA 510(k)

FDA Class 2 ·Microbiology

Diazyme Procalcitonin (PCT) Assay, Diazyme Procalcitonin (PCT) Calibrator Set, Diazyme Procalcitonin (PCT) Control Set

FDA 510(k)

FDA Class 2 ·Microbiology

DiaSys Procalcitonin FS; DiaSys TruCal Procalcitonin Calibrator Set; DiaSys TruLab Procalcitonin Bi-Level Controls

FDA 510(k)

FDA Class 2 ·Microbiology

Access PCT, Access PCT Calibrators

FDA 510(k)

FDA Class 2 ·Microbiology

SURGICAL FACE MASKS PLUS ANTI-FOG SHIELD

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery