PLANMECA INTRACAM

FDA 510(k)

FDA Class 1 ·Dental

DUET SUTURE ANCHOR

FDA 510(k)

FDA Class 2 ·Orthopedic

INION HEXALON BIODEGRADABLE ACL/PCL SCREW

FDA 510(k)

FDA Class 2 ·Orthopedic

LITHIUM MICRO VOLUME ELECTRODE, THEOPHYLLINE, ISE CALIBRATORS 1, 2 AND 3, TDM CALIBRATION SET B, NORTROL AND ABTROL

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

RUBALEX

FDA 510(k)

FDA Class 2 ·Microbiology

BIOSORBPDX BIOABSORBABLE FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

DELIGHT

FDA 510(k)

FDA Class 1 ·Dental

SATLITE PLUS PULSE OXIMETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

TRANSFERRIN, SPECICAL CALIBRATOR, SPECITROL AND SPECITROL HIGH CONTROLS

FDA 510(k)

FDA Class 2 ·Immunology

PLANMED CYTOGUIDE

FDA 510(k)

FDA Class 2 ·Radiology

ORION DIAGNOSTICA UNIQ PINP RIA

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MoistureMeterD Compact, LymphScanner

FDA 510(k)

FDA Class 2 ·Cardiovascular

CARBON DIOXIDE (CO2), SCAL, NORTROL AND ABTROL

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

OPTOMED SMARTSCOPE, MODEL M3-1 EY1

FDA 510(k)

FDA Class 2 ·Ophthalmic

SMART SCREW ACL MODELS 237020, 237025, 237030, 238020, 238025, 238030, 239020, 239025, 239030

FDA 510(k)

FDA Class 2 ·Orthopedic

Entropy Module, E-ENTROPY-01

FDA 510(k)

FDA Class 2 ·Neurology

INION S-1 BIODEGRADABLE ANTERIOR CERVICAL FUSION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

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)

FDA 510(k)

FDA Class 2 ·Neurology

CARBAMAZEPINE, VALPROIC ACID, TDM CALIBRATION SET B AND ABTROL, NORTROL CONTROLS

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

MAMEX DC S SL10/MG14

FDA 510(k)

FDA Class 2 ·Radiology