OTICON I31 INITIALES HEARING AID

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

Well Lead Extraction Bag

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CORE1 Implant System

FDA 510(k)

FDA Class 2 ·Dental

QUATERA 700

FDA 510(k)

FDA Class 2 ·Ophthalmic

OTICON, CITEC CUSTOM MADE HEARING AID CANAL TYPE

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

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

AIO HD OTOSCOPE

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

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

POWDER FREE NITRILE EXAMINATION GLOVES

FDA 510(k)

FDA Class 1 ·General Hospital

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

FDA 510(k)

FDA Class 2 ·Radiology

I22 INITIALES

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

Lunit INSIGHT DBT

FDA 510(k)

FDA Class 2 ·Radiology

MetaLite DX Digital Pathology Software

FDA 510(k)

FDA Class 2 ·Pathology