MODEL FAMILY OF AEROLASE ND:YAG LASERS: FRIENDLYLIGHT ND: YAG LASERS, FRIENDLYLIGHT NEO, LIGHTPOD ND: YAG LASERS, LIGHTP

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Neo - Arthroscope (Rigid) 2.0mm/3.5mm, Outer sheath/ cannula, Outer sheath/ cannula w/ Handle, Trocar for outersheath/ cannula

FDA 510(k)

FDA Class 2 ·Orthopedic

System, Test, Osteocalcin

FDA classification

FDA Class 2 ·System, Test, Osteocalcin

V2465P X-RAY IMAGE INTENSIFIER

FDA 510(k)

FDA Class 2 ·Radiology

ERBOKRYO CA CRYOSURGICAL SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

FACTOR IX DEFICIENT PLASMA, B9D -

FDA 510(k)

FDA Class 2 ·Hematology

NEURONET

FDA 510(k)

FDA Class 2 ·Neurology

Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and related 610i, 620i, 630i series enabled to retrofit RFID features); Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-1, SLS XXX, Multiple Models Pending Configuration)

FDA 510(k)

FDA Class 2 ·Anesthesiology

PHACO TIP

FDA 510(k)

FDA Class 2 ·Ophthalmic

QCS HER2 IMMUNOCONTROLS (PRODUCT NO. C010)

FDA 510(k)

FDA Class 2 ·Hematology

BAYER IMMUNO 1 HER-2/NEU ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

Her-2, ER, PR IHControls

FDA 510(k)

FDA Class 2 ·Hematology

MANUAL HER-2/NEU MICROTITER ELISA (OSDI HER-2/NEU ELISA)

FDA 510(k)

FDA Class 2 ·Immunology

BAYER ADVIA CENTAUR HER-2/NEU ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

Visaris Avanse

FDA 510(k)

FDA Class 2 ·Radiology

Visaris Vision® (Vision C, Vision U. Vision V, Vision X)

FDA 510(k)

FDA Class 2 ·Radiology

CONVERGENCE CDR FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERAS

FDA 510(k)

FDA Class 2 ·Radiology

HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERA SYSTEM WITH THICK NAL(TI) CRYSTAL

FDA 510(k)

FDA Class 2 ·Radiology

HITACHI SPECTRADIGITAL SERIES GAMMA CAMERA SYSTEMS

FDA 510(k)

FDA Class 2 ·Radiology

CORDIS STRAIGHT OR FINNED VENTR CATH (W/RADIO DOTS)

FDA 510(k)

FDA Class 2 ·Neurology