CLEARBLUE EASY EARLY RESULT PREGNANCY TEST

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

hekaDrill

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

CLEARBLUE PREGNANCY TESTING KIT (MODIFICATION)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SWIFT FX

FDA 510(k)

FDA Class 2 ·Anesthesiology

Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell, MetaFix™ Hip System, TriFit™ CF and TS Hip Systems, TaperFit™ Hip System, Revival™ Modular Hip System, MiniHip™, Trinity™ Dual Mobility, MobiliT, BiPolar-i, OMNI MOD™ Hip System, OMNI K1 and K2 Hip Systems, OMNI Bipolar Heads, Corin Biolox Delta Ceramic Heads, OMNI Delta Ceramic Heads

FDA 510(k)

FDA Class 2 ·Orthopedic

INION CPS BSSO SCREW

FDA 510(k)

FDA Class 2 ·Orthopedic

PolyDev Soft Contact Lenses

FDA 510(k)

FDA Class 2 ·Ophthalmic

DOUBLE-HOLE PENCILE-POINT SPINAL NEEDLE (DHPP SPINAL NEEDLE)

FDA 510(k)

FDA Class 2 ·Anesthesiology

GENTAMICIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC

FDA 510(k)

FDA Class 2 ·Microbiology

HeraBEAT™ US

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

DG EXAMINER PLUS

FDA 510(k)

FDA Class 2 ·Neurology

INTEGRITY MODEL 1014284

FDA 510(k)

FDA Class 2 ·Radiology

ACTIVATM PRODUCT GROUP INCLUDING BIOABSORBABLE DEVICES ACTIVAPIN FUSION, ACTIVANAILTM CONICALTM

FDA 510(k)

FDA Class 2 ·Orthopedic

OPUS 20, MODEL 1ST

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CPS 1.5/2.0/2.5 BIOABSORBABLE FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

TIGRAN HIP PROSTHESIS

FDA 510(k)

FDA Class 2 ·Orthopedic

WHISPERFLOW OXYGEN FLOW GENERATOR - ADJUSTABLE MODEL WF 8500 WHISPERFLOW OXYGEN FLOW GENERATOR - FIXED MODEL WF 8530 WH

FDA 510(k)

FDA Class 2 ·Anesthesiology

ALLOGRAN-N-BONE VOID FILLER

FDA 510(k)

FDA Class 2 ·Orthopedic

CARBON DIOXIDE (C02) MICROSURGICAL LASER

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

LATEX CONDOM

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology