AUTOMATED VITRECTOMY DEVICE

FDA 510(k)

FDA Class 2 ·Ophthalmic

MODIFICATION TO REFLOTRON AMYLASE, CAT. 1200658

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)

FDA 510(k)

FDA Class 2 ·Orthopedic

Elecsys BRAHMS PCT

FDA 510(k)

FDA Class 2 ·Microbiology

SERIM DISINTEK OPA TEST STRIP

FDA 510(k)

FDA Class 2 ·General Hospital

Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MIMIX BONE REPLACEMENT SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

MODIFICATION TO: STERILE COLLES CLASSIC FIXATOR

FDA 510(k)

FDA Class 2 ·Orthopedic

MODIFICATION TO DEPUY DELTA XTEND REVERSE SHOULDER SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

LACTOSORB TIBIAL L-15 SCREW AND WASHER

FDA 510(k)

FDA Class 2 ·Orthopedic

BE PLUS / AURA-LTM64 AMPLIFIER

FDA 510(k)

FDA Class 2 ·Neurology

ZCA ALL-POLY ACETABULAR CUP, SNAP-IN, MODEL 8005-946/958-32

FDA 510(k)

FDA Class 2 ·Orthopedic

Elecsys Syphilis

FDA 510(k)

FDA Class 2 ·Microbiology

SERIM DISINTEK GTA 2.1%, MODEL: 5164

FDA 510(k)

FDA Class 2 ·General Hospital

ULTRASOUND PROBE BIOPSY ACCESSORIES

FDA 510(k)

FDA Class 2 ·Radiology

VAPOTHERM MODEL#2000I, 200H

FDA 510(k)

FDA Class 2 ·Anesthesiology

GUNTHER TULIP VENA CAVA MREYE FILTER SET

FDA 510(k)

FDA Class 2 ·Cardiovascular

CLP 0.02 M CALCIUM CHLORIDE SOLUTION.

FDA 510(k)

FDA Class 2 ·Hematology

MOSAIC NON-MODULAR PROXIMAL BODY AND EAS OFFSET MODULAR HUMERAL HEAD

FDA 510(k)

FDA Class 2 ·Orthopedic