P2000 FluidSmart Fluid Management system (at the time of clearance, this was called “Thermedx 37-5”)

FDA registration

THERMEDX, LLC·1 product·🇺🇸 United States

THERMEDX PRODIGY FLUID MANAGEMENT SYSTEM, MODELS P1000, P2000

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Insufflator, Hysteroscopic

FDA classification

FDA Class 2 ·Insufflator, Hysteroscopic

Synergy Health AST, LLC

FDA registration

Synergy Health AST, LLC·2 products·🇺🇸 United States

ALLOMATRIX

FDA registration

WRIGHT MEDICAL TECHNOLOGY, INC.·2 products·🇺🇸 United States

Synergy Health AST, LLC

FDA registration

Synergy Health AST, LLC·2 products·🇺🇸 United States

ALLOMATRIX

FDA registration

WRIGHT MEDICAL TECHNOLOGY, INC.·2 products·🇺🇸 United States

BLACKSTONE SURGICAL TITANIUM MESH SYSTEM ANGLED END RINGS

FDA registration

ORTHOFIX US LLC·1 product·🇺🇸 United States

Merit Medical®

FDA UDI

Merit Medical Systems, Inc.·00884450360965·

Anti-Desmoglein 1 ELISA (IgG)

FDA registration

EUROIMMUN US INC.·1 product·🇺🇸 United States

Anti-Desmoglein 3 ELISA (IgG)

FDA registration

EUROIMMUN Medizinische Labordiagnostika AG·1 product·🇩🇪 Germany

Sekisui Diagnostics P.E.I. Inc.

FDA registration

Sekisui Diagnostics P.E.I. Inc.·1 product·🇨🇦 Canada

Anti-Desmoglein 3 ELISA (IgG)

FDA registration

EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG·1 product·🇩🇪 Germany

KOWA FM-600

FDA registration

KOWA CO. LTD. CHOFU·1 product·🇯🇵 Japan

ADVIA Chemistry

FDA registration

Siemens Healthcare Diagnostics Inc.·1 product·🇺🇸 United States

VITALCARE FOLEY CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

FOTONA DUALIS, FOTONA DUALIS PLUS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Catheter, Retention Type, Balloon

FDA classification

FDA Class 2 ·Catheter, Retention Type, Balloon

Powered Laser Surgical Instrument

FDA classification

FDA Class 2 ·Powered Laser Surgical Instrument