OP300

FDA 510(k)

FDA Class 2 ·Radiology

Icare HOME tonometer

FDA 510(k)

FDA Class 2 ·Ophthalmic

LIPOPROTEIN(A), LIPOPROTEIN(A) CALIBRATOR, LIPOPROTEIN (A) CONTROL, CONTROL HIGH

FDA 510(k)

FDA Class 2 ·Immunology

Orthopantomograph™ OP 3D LX (PAN 3D); Orthopantomograph™ OP 3D LX (PAN CEPH 3D)

FDA 510(k)

FDA Class 2 ·Radiology

SCAN300FP / RETROPAN (VDC)

FDA 510(k)

FDA Class 2 ·Dental

ELEKTA OY

FDA 510(k)

FDA Class 2 ·Neurology

LITHIUM MICRO VOLUME ELECTRODE, THEOPHYLLINE, ISE CALIBRATORS 1, 2 AND 3, TDM CALIBRATION SET B, NORTROL AND ABTROL

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

TRANSFERRIN, SPECICAL CALIBRATOR, SPECITROL AND SPECITROL HIGH CONTROLS

FDA 510(k)

FDA Class 2 ·Immunology

ORION DIAGNOSTICA UNIQ PINP RIA

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1)

FDA 510(k)

FDA Class 2 ·Neurology

CARBAMAZEPINE, VALPROIC ACID, TDM CALIBRATION SET B AND ABTROL, NORTROL CONTROLS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Icare ic100

FDA 510(k)

FDA Class 2 ·Ophthalmic

COMPLEMENT C3 AND C4, SPECICAL CALIBRATOR AND SPECITROL CONTROL AND HIGH CONTROL

FDA 510(k)

FDA Class 2 ·Immunology

ELEKTA NEUROMAG WITH MAXFILTER

FDA 510(k)

FDA Class 2 ·Neurology

iCare IC200

FDA 510(k)

FDA Class 2 ·Ophthalmic

iCare ST500 (TA04)

FDA 510(k)

FDA Class 2 ·Ophthalmic

Surgify Halo

FDA 510(k)

FDA Class 2 ·Neurology

Orthopantomograph OP300

FDA 510(k)

FDA Class 2 ·Radiology

Orthopantomograph OP 3D

FDA 510(k)

FDA Class 2 ·Radiology

Contour+ (MVision AI Segmentation)

FDA 510(k)

FDA Class 2 ·Radiology