REPROBEAD TSH ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 107)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SYNTHACER; SYNTRICER

FDA 510(k)

FDA Class 2 ·Orthopedic

eMVFit (MVF-10M)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SPACELABS MODEL 90201 HOLTER RECORDER

FDA 510(k)

FDA Class 2 ·Cardiovascular

ELECTROSURGICAL INFANT PATIENT RETURN ELECTRODE, DUAL PLATE WITH CORD, MODEL EP 211M

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Well Lead PVC Urethral Catheter

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

REPROBEAD T4 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 105)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear

FDA 510(k)

FDA Class 2 ·Ophthalmic

ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW)

FDA 510(k)

FDA Class 2 ·Radiology

Lunit INSIGHT DBT

FDA 510(k)

FDA Class 2 ·Radiology

MetaLite DX Digital Pathology Software

FDA 510(k)

FDA Class 2 ·Pathology

CALLISTO eye

FDA 510(k)

FDA Class 2 ·Radiology

CareStart Flu A&B Plus

FDA 510(k)

FDA Class 2 ·Microbiology

Rebuilder Nerve Guidance Conduit

FDA 510(k)

FDA Class 2 ·Neurology

BLUE 400

FDA 510(k)

FDA Class 2 ·Neurology

COOLTOUCH ND: YAG LASER SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

EYE SECRET 38 UV ASPHERIC (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR

FDA 510(k)

FDA Class 2 ·Ophthalmic

QUATERA 700

FDA 510(k)

FDA Class 2 ·Ophthalmic

WELL LEAD SILICONE AND LATEX FOLEY CATHETERS

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology