MODIFIED COHERENT ULTRAPULSE CO2 SURGICAL LASERS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

NIDEK/PHACO EMULSIFICATION SYSTEM MODEL CV-8000

FDA 510(k)

FDA Class 2 ·Ophthalmic

PLASTIC NEEDLE WITH MANDRIN, 2.0 MM DIAMETER, LENGTH, BLUNT TIP,PLASTIC NEEDLE WITH MANDRIN, 2.0 MM DIAMETER, LENGTH 113

FDA 510(k)

FDA Class 2 ·Radiology

EMIT T-UPTAKE ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VARISOURCE BREAST TEMPLATE SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

BARCODE CONICAL COLLIMATOR VERIFICATION (BCCV)

FDA 510(k)

FDA Class 2 ·Radiology

IMAGE VASCULAR LASER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

EMIT CONVENIENCE PACK, QUINIDINE ASSAY/CALIBRATORS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

MODEL 5001 MICROMANIPULATOR FOR USE W/TF-25 CO2

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Varian Head Frame

FDA 510(k)

FDA Class 2 ·Radiology

EMIT CALIBRATOR B LEVEL 1(CUTOFF) & LEVEL 2(HIGH)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

COAPT ENDOTINE MIDFACE-ST 4.5 DEVICE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

TrueBeam, TrueBeam STx, Edge, VitalBeam

FDA 510(k)

FDA Class 2 ·Radiology

EXACTRAC (BRAINLAB PATIENT POSITIONING SYSTEM)

FDA 510(k)

FDA Class 2 ·Radiology

COHERENT MARIE ARGON PHOTOCOAGULATOR

FDA 510(k)

FDA Class 2 ·Ophthalmic

VISION (WITH OFF-LINE REVIEW)

FDA 510(k)

FDA Class 2 ·Radiology

Cognoa ASD Diagnosis Aid

FDA 510(k)

FDA Class 2 ·Neurology

NIDEK US-3000

FDA 510(k)

FDA Class 2 ·Radiology

EMIT(R) II BARBITURATE ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

EMIT CONVENIENCE PACK: PHENYTOIN ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology