EMILITH ELECTROMECHANICALIMPACTOR LITHOTRIPSY PROB

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

INSTRUMENT IRRIGATION PUMP

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

FLOWMATE HAND PUMP

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

EHL PULSE GENERATOR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·ROTABLATOR(R) ROTATIONAL ANGIOPLASTY SYSTEM

Synapse Pathology

FDA UDI

Fujifilm Healthcare Americas Corporation·00854904006039·Dynamyx Digital Pathology Software is a client-...

PSI Casting Liner Kit 6/3mm

Device

EU MDR · Eu Md Class 1 ·Alps South, LLC·On the market·20 countries

Cranial PSI Accessory – Anatomical Model Original, Cranial PSI Accessory – Anatomical Model Modified, Cranial PSI Accessory – Plastic Drawing Guide, Cranial PSI Accessory – Cranial Implant Trial

FDA 510(k)

FDA Class 2 ·Neurology

PST-30BT(5S2), PST-50BT(6S3), PEI-512VX(i6SVX2), PET-508MA(7S3), PET-512MD(8SM2), PET-805LA(12LI4), PC-20M(P2), PC-50M

FDA registration

Modality Group Ltd·3 products·🇬🇧 United Kingdom

Western/Scott Fetzer

FDA UDI

WESTERN/SCOTT FETZER COMPANY·B929M1950PG0·M1 ADJ.REG 0-100 PSI/CGA950

N/A

FDA UDI

SALTER LABS·00607411200915·Bubble humidifier, 6 PSI, safety valve

NA

FDA UDI

MEDTRONIC, INC.·00763000360931·CUSTOM PACK HY10Q87R6 PSI IA WI

Western/Scott Fetzer

FDA UDI

WESTERN/SCOTT FETZER COMPANY·B929M1973PG0·M1 ADJ.REG 0-100 PSI/CGA973

Western/Scott Fetzer

FDA UDI

WESTERN/SCOTT FETZER COMPANY·B929M1910P0·REG. M1 SERIES PRESET 50 PSI

Western/Scott Fetzer

FDA UDI

WESTERN/SCOTT FETZER COMPANY·B929M1870P0·REG. M1 SERIES PRESET 50 PSI

Western/Scott Fetzer

FDA UDI

WESTERN/SCOTT FETZER COMPANY·B929M1960PG0·M1 ADJ.REG 0-100 PSI/CGA960

Western/Scott Fetzer

FDA UDI

WESTERN/SCOTT FETZER COMPANY·B929M1540P0·REG. M1 SERIES PRESET 50 PSI

NA

FDA UDI

MEDTRONIC, INC.·00763000315627·CUSTOM PACK 11C10R 4PK PSI TAVR

Western/Scott Fetzer

FDA UDI

WESTERN/SCOTT FETZER COMPANY·B929M1A540P0·CGA 540 PRESET 50 PSI REGULATR

Flowmeter

FDA UDI

MAXTEC, LLC·00817770022763·Flowmeter, 200cc White Thorpe 50 PSI