INION CPS/OTPS FREEDOMPLATE

FDA 510(k)

FDA Class 2 ·Orthopedic

Bonalive Orthopedics granules

FDA 510(k)

FDA Class 2 ·Orthopedic

ANAESTHESIA RECORD KEEPER

FDA 510(k)

FDA Class 2 ·Anesthesiology

PLANMECA PROMAX 3D MAX

FDA 510(k)

FDA Class 2 ·Dental

PM2002 CC, ARISTOCRAT AND ARISTOCRAT DELUXE

FDA 510(k)

FDA Class 2 ·Anesthesiology

INION TRINION BIODEGRADABLE MENISCUS SCREW

FDA 510(k)

FDA Class 2 ·Orthopedic

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

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MENISCUS ARROW SHEATH #CN1000A; SMARTSCREW ACL SHEATH #SSA2000A

FDA 510(k)

FDA Class 2 ·Orthopedic

DELFIA CORTISOL KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ORTHOPANTOMOGRAPH 100

FDA 510(k)

FDA Class 2 ·Dental

INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

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

FDA 510(k)

FDA Class 2 ·Immunology

ORICULT-N CULTURE-PADDLE

FDA 510(k)

FDA Class 1 ·Microbiology

MICROALBUMINURIA ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

AS/3 ANAESTHESIA MONITORING SYSTEM AIRWAY MODULE

FDA 510(k)

FDA Class 2 ·Anesthesiology

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

FDA 510(k)

FDA Class 2 ·Immunology

DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-ANEO7 AND L-ANEO7A SOFTWARE USING F-CU8 OR F-CU5 (P) MONITOR FRAME OPTIONS AN

FDA 510(k)

FDA Class 2 ·Cardiovascular

MRCAT Pelvis

FDA 510(k)

FDA Class 2 ·Radiology

MRCAT

FDA 510(k)

FDA Class 2 ·Radiology

MOBILE SOPHIE MODIFICATION

FDA 510(k)

FDA Class 2 ·Radiology