11 results
·
19ms
·
Sources: EU EUDAMED, US FDA
DRAGER ORMC
FDA 510(k)
FDA Class 2
·Anesthesiology
PEDIATRIC FIXATION RODS
FDA 510(k)
FDA Class 2
·Orthopedic
SUCCESS CECAL INTUBATION ASSIST, MODEL: 4100
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
STEAM STER LOCKS ORANGE
FDA Adverse Event
Injury
·AESCULAP INC·Product code KCT·October 12, 2016
FOLYSIL OVERGUIDE 5/15 ML CH18
FDA Adverse Event
Malfunction
·COLOPLAST A/S·Product code EZL·May 8, 2014
MANUAL FEED ADULT HUMIDIFICATION CHAMBER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·October 22, 2012
TRANSTAR STRETCHER
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FPO·August 4, 2010
ARTERIAL FOR COBE C2 6.35MM NO CHAMBER
FDA Adverse Event
Injury
·ERIKA DE REYNOSA·Product code FJK·April 23, 1998
STEAM STER LOCKS ORANGE
FDA Adverse Event
Malfunction
·AESCULAP INC·Product code KCT·July 26, 2016
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021
Pinnacle Cups, Part numbers 121701048 121701050 121701052 121701054 121701056 121701058 121701060 121701062 121711048 121711052 121712050 121712052 121712056 121722048 121722050 121722052 121722054 121722056 121722058 121722060 121722062 121731048 121731050 121731052 121731054 121731056 121731058 121731060 121731062 121732048 121732050 121732052 121732054 121732056 121732058 121732060 121732062 121732064 - Product Usage: The PINNACLE CUP devices are part of the Pinnacle Hip Solution for the anatomic reconstruction of the hip joint, which promotes prosthetic joint load and function.
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·January 13, 2021