10,000 results · 233ms · Sources: EU EUDAMED, US FDA

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

FS Ergo

FDA 510(k)
FDA Class 2 ·Dental

PHENOBARBITAL, PHENYTOIN, TDM CALIBRATION SET B AND ABTROL/NORTROL CONTROLS

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

OP300

FDA 510(k)
FDA Class 2 ·Radiology

Icare ic200

FDA 510(k)
FDA Class 2 ·Ophthalmic

ORTHOPANTOMOGRAPH OP 3D

FDA 510(k)
FDA Class 2 ·Radiology

Icare HOME Tonometer

FDA 510(k)
FDA Class 2 ·Ophthalmic

ELEKTA NEUROMAG WITH MAXWELL FILTER

FDA 510(k)
FDA Class 2 ·Neurology

iCare HOME2

FDA 510(k)
FDA Class 2 ·Ophthalmic

SCANORA 3DX

FDA 510(k)
FDA Class 2 ·Radiology

MYSET PREGNANCY TEST

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

HBA1C; CALIBRATOR; CONTROL NORMAL, CONTROL ABNORMAL

FDA 510(k)
FDA Class 2 ·Hematology

DPC T60I KUSTI, MODEL 984248; DPC T60I, MODEL 984247

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument

FDA 510(k)
FDA Class 2 ·Immunology

DITER ULTRASONIC S 3000

FDA 510(k)
FDA Class 2 ·Physical Medicine

QUICKREAD SYSTEM: QUICKREAD CRP KIT, MODEL 06085; QUICKREAD 101 INSTRUMENT, MODEL 06088; QUICKREAD CRP CONTROL SET, MODE

FDA 510(k)
FDA Class 2 ·Immunology

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); Surgify Halo (40.070.NVG.H1); Surgify Halo (40.125.NVG.H1); Surgify Halo (40.000.SEE.H1)

FDA 510(k)
FDA Class 2 ·Neurology

ELEKTA NEUROMAG WITH MAXWELL FILTER WITH INTERNAL ACTIVE SHIELDING

FDA 510(k)
FDA Class 2 ·Neurology