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

URODYN 1000

FDA 510(k)

FDA Class 1 ·Gastroenterology, Urology

ELLIPSE LIGHT SPT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

OMEGA BIVALVE NASAL SPLINTS

FDA 510(k)

FDA Class 1 ·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

OMEGA NASAL SEPTAL BUTTON

FDA 510(k)

FDA Unclassified ·Unknown

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

WIRION Embolic Protection System

FDA registration

Cardiovascular Systems Incorporated·1 product·🇺🇸 United States

Bemis SharpSentinal

FDA registration

BEMIS MANUFACTURING CO.·1 product·🇺🇸 United States

Filter Paper

FDA registration

MBM PACKAGING LABS, INC·1 product·🇺🇸 United States

DIAMONDBACK 360 Peripheral Orbital Atherectomy System

FDA registration

Cardiovascular Systems Incorporated·1 product·🇺🇸 United States