17 results · 43ms · Sources: EU EUDAMED, US FDA

Dimension Vista High-Sensitivity Troponin I (TNIH) Assay

FDA registration
SIEMENS HEALTHCARE DIAGNOSTICS INC.·1 product·🇺🇸 United States

Dimension Vista High-Sensitivity Troponin I (TNIH) Assay

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Immunoassay Method, Troponin Subunit

FDA classification
FDA Class 2 ·Immunoassay Method, Troponin Subunit

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04049772814220·GENUMEDI PT SILVER L V

Sorin Centrifugal Pump 5 (CP5)

FDA registration
LivaNova Deutschland GmbH·1 product·🇩🇪 Germany

BreathIQ

FDA registration
AlcoPro Inc·1 product·🇺🇸 United States

Yellowstone

FDA UDI
SUMMIT SPINE LLC·B587X1822250·18mm H x 22mm W x 25mm L x 0 degrees XLIF

Vilex Power Accessory

FDA UDI
VILEX IN TENNESSEE, INC.·00841731122292·Kwire .070X9" (1.8x225mm)

SUNTANNING DEVICE (SEPAR. FROM K812225)

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

Yellowstone

FDA UDI
SUMMIT SPINE LLC·B587X18222580·18mm H x 22mm W x 25mm L x 8 degrees XLIF

Yellowstone

FDA UDI
SUMMIT SPINE LLC·B587L182225120·18mm H x 22mm W x 25mm L XLIF Trial 12 degree L...

Yellowstone

FDA UDI
SUMMIT SPINE LLC·B587X182225120·18mm H x 22mm W x 25mm L x 12 degrees XLIF

EUROFINS INPAC MEDIZINTECHNIK GMBH

FDA registration
EUROFINS INPAC MEDIZINTECHNIK GMBH·1 product·🇩🇪 Germany

ALCO-BREATH TUBE, CHECKPOINT BREATH ALCOHOL TEST

FDA 510(k)
FDA Class 1 ·Clinical Toxicology

15W CERALAS D 1470NM DIODE LASER, MODEL D1470

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

Devices, Breath Trapping, Alcohol

FDA classification
FDA Class 1 ·Devices, Breath Trapping, Alcohol

Powered Laser Surgical Instrument

FDA classification
FDA Class 2 ·Powered Laser Surgical Instrument