HEMODIALYSIS SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CoreGateway

FDA registration

Core Sound Imaging·1 product·🇺🇸 United States

Inbrija

FDA registration

MERZ PHARMACEUTICALS, LLC·1 product·🇺🇸 United States

Brasseler USA

FDA UDI

Peter Brasseler Holdings, LLC·00887919684893·AS6A ARK STONE FINE SLIP 1P

Medline Industries, Inc.

FDA UDI

MEDLINE INDUSTRIES, INC.·10889942861170·ORTHO ARK MINOR SET UP-LF

N/A

FDA UDI

INNOVATIVE HEALTH LLC·10841898129797·Reprocessed BRK Transseptal Needle, 98 cm

N/A

FDA UDI

INNOVATIVE HEALTH LLC·10841898129759·Reprocessed BRK Transseptal Needle, 71 cm

N/A

FDA UDI

INNOVATIVE HEALTH LLC·10841898129773·Reprocessed BRK Transseptal Needle, 89 cm

Brasseler USA

FDA UDI

Peter Brasseler Holdings, LLC·00887919684909·ASKC ARK STONE FINE CYL 1P

Medline Industries, Inc.

FDA UDI

MEDLINE INDUSTRIES, INC.·10193489287158·ORTHO ARK MINOR SET UP-LF

Medline Industries, Inc.

FDA UDI

MEDLINE INDUSTRIES, INC.·10884389240724·S. ARK MEDICAL CTN NEWBORN KIT

Medline Industries, Inc.

FDA UDI

MEDLINE INDUSTRIES, INC.·10193489955880·ORTHO ARK MINOR SET UP-LF

Brasseler USA

FDA UDI

Peter Brasseler Holdings, LLC·00887919838883·649.11.420 HP ARK FLT TAP 1P

n/a

FDA UDI

MEDTRONIC SOFAMOR DANEK, INC.·00643169789425·RETRACTOR X0516118 DUAL BRK TBL 19MMX8CM

Medline Industries, Inc.

FDA UDI

MEDLINE INDUSTRIES, INC.·10193489914306·ORTHO ARK MINOR SET UP-LF

Medline Industries, Inc.

FDA UDI

MEDLINE INDUSTRIES, INC.·10195327279257·ORTHO ARK MINOR SET UP-LF

n/a

FDA UDI

MEDTRONIC SOFAMOR DANEK, INC.·00643169789432·RETRACTOR X0516119 DUAL BRK TBL 19MMX9CM

Brasseler USA

FDA UDI

Peter Brasseler Holdings, LLC·00887919684886·AS4 ARK STONE FINE FLAT 1P

Medline Industries, Inc.

FDA UDI

MEDLINE INDUSTRIES, INC.·10888277205901·ORTHO ARK MINOR SET UP-LF

ARK™ Pregabalin II Calibrator

FDA UDI

ARK DIAGNOSTICS INC·00812101030455·ARK™ Pregabalin II Calibrator is intended for u...