Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MIS

FDA 510(k)

FDA Class 2 ·Orthopedic

ISIS MER SYSTEM/ELEKTA MER SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

MICRO-RECORDING AND STIMULATION ELECTRODES-MICRO MACROELECTRODE MODEL NO. 230700-230799

FDA 510(k)

FDA Class 2 ·Neurology

ELECSYS ANTI-TSHR IMMUNOASSAY, ELECSYS PRECICONTROL THYROAB

FDA 510(k)

FDA Class 2 ·Immunology

BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants

FDA 510(k)

FDA Class 2 ·Dental

ARCHITECT STAT CK-MB IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ELEKTA OY

FDA 510(k)

FDA Class 2 ·Neurology

ORAJEL ADVANCED TOOTH DESENSITIZER

FDA 510(k)

FDA Class 2 ·Dental

NTI TENSION SUPPRESSION SYSTEM, WITH A SNOREHOOK APPLICATION

FDA 510(k)

FDA Class 2 ·Dental

ARCHITECT STAT TROPONIN-1; MYOGLOBIN

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ARCHITECT STAT MYO IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Immunology

ARCHITECT STAT TROPONIN-I IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

JOVI MYELOGRAPHY HARNESS

FDA 510(k)

FDA Class 2 ·Radiology

PUTMAN STABILIZER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MB

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CHEMSTRIP 5 OB, CHEMSTRIP 7 AND CHEMSTRIP 10 MD TEST STRIPS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ROCHE ONLINE TDM PHENYTOIN

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ELECSYS CORTISOL TEST SYSTEM, ADDITION OF SALIVA SAMPLE TYPE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

3MENSIO WORKSTATION

FDA 510(k)

FDA Class 2 ·Radiology

CAAS II RVA

FDA 510(k)

FDA Class 2 ·Radiology