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CREWT MEDICAL SYSTEMS, INC

FDA registration
CREWT MEDICAL SYSTEMS, INC·2 products·🇯🇵 Japan

imovifa

FDA UDI
CREWT MEDICAL SYSTEMS, INC.·04573277310111·An imovifa is used to perform visual field test...

Boston Scientific TSX Transseptal Needle, Model Number M004TSX60o; Used to create the primary puncture in the interatrial septum when passing an intruder and/or catheter through the septum from the right side of the heart to the left side.

FDA Enforcement
Class II ·Terminated·Merit Medical Systems, Inc.·April 20, 2016

FREESTYLE COMFORT

FDA Adverse Event
Malfunction ·CAIRE INC.·Product code CAW·September 1, 2022

CORGRIP SR NASOGASTRIC/NASOINTESTINAL FEEDING TUBE RETENTION SYSTEM

FDA Adverse Event
Malfunction ·AVANOS MEDICAL INC.·Product code KNT·March 10, 2026

NIDEK EC-5000 EXCIMER LASER SYSTEM

FDA Adverse Event
Injury ·NIDEK CO. LTD·Product code LZS·May 10, 2010

EDISON SYSTEM

FDA Adverse Event
Injury ·HISTOSONICS, INC.·Product code QGM·March 30, 2026

SYNCHRON CX DELTA CLINICAL SYSTEM

FDA Adverse Event
Malfunction ·BECKMAN COULTER, INC.·Product code JJE·January 6, 2012

O-ARM 1000 IMAGING SYSTEM

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION, INC. (LITTLETON)·Product code OXO·November 16, 2016

CATALYS SYSTEM

FDA Adverse Event
Malfunction ·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code OOE·April 30, 2019

IMMAGE IMMUNOCHEMISTRY SYSTEM

FDA Adverse Event
Malfunction ·BECKMAN COULTER, INC.·Product code JJE·January 3, 2012

DADE INNOVIN

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH·Product code GJS·June 9, 2017

NEWLIFE INTENSITY 10

FDA Adverse Event
Malfunction ·CAIRE INC.·Product code CAW·May 21, 2020

O-ARM 1000 IMAGING SYSTEM

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION, INC. (LITTLETON)·Product code OXO·December 2, 2016

CATALYS SYSTEM

FDA Adverse Event
Malfunction ·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code OOE·October 25, 2019

BALLARD CLOSED SUCTION SYSTEM FOR ADULTS, DOUBLE SWIVEL ELBOW

FDA Adverse Event
Malfunction ·AVANOS MEDICAL INC.·Product code BSY·January 10, 2023

BALLARD CLOSED SUCTION SYSTEM FOR ADULTS, DOUBLE SWIVEL ELBOW

FDA Adverse Event
Malfunction ·AVANOS MEDICAL INC.·Product code BSY·January 10, 2023

APEX

FDA Adverse Event
Malfunction ·B. BRAUN MEDICAL INC.·Product code NEP·November 4, 2020

INTROCAN SAFETY®

FDA Adverse Event
Injury ·B. BRAUN MELSUNGEN AG·Product code DYB·March 1, 2019

DA VINCI SI SURGICAL SYSTEM

FDA Adverse Event
Injury ·INTUITIVE SURGICAL,INC.·Product code NAY·September 20, 2013