Ellipse Ydun

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys Ultra

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ELLIPSE 12PL, MODEL 9ESL7228

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AQT90 FLEX CKMB TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LEVELS 1-3, AQT90 FLEX CKMB CAL CARTRIDGE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

HEMOCLOT QUANTI- V-L, FACTOR V-L CALIBRATOR, BIOPHEN V-L CAL (UNDILUTED), BIOPHEN ACT. PC-R CONTROL PLASMA AND BIOPHEN

FDA 510(k)

FDA Class 2 ·Hematology

ELLIPSE JUVIA, MODEL 9EJU7465

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

OMEGA SILICONE CHIN IMPLANT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ELLIPSE LIGHT SPT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BIOPHEN PROTEIN C5, C2.5, MODELS 221205, 221202

FDA 510(k)

FDA Class 2 ·Hematology

Ellipse Frax 1940 for Ellipse Nordlys and Ellipse Ydun

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 221105

FDA 510(k)

FDA Class 2 ·Hematology

OMEGA DORSAL COLUMELLA IMPLANTS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6

FDA 510(k)

FDA Class 2 ·Hematology

ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040A

FDA 510(k)

FDA Class 2 ·Hematology

StimQ Peripheral Nerve Stimulator (PNS) System

FDA 510(k)

FDA Class 2 ·Neurology

Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG Accessory Kit, Charger Kit

FDA 510(k)

FDA Class 2 ·Neurology

Freedom Spinal Cord Stimulator System

FDA 510(k)

FDA Class 2 ·Neurology

Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit

FDA 510(k)

FDA Class 2 ·Neurology

Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit

FDA 510(k)

FDA Class 2 ·Neurology

ARC

FDA 510(k)

FDA Class 2 ·Anesthesiology