13 results
·
26ms
·
Sources: EU EUDAMED, US FDA
TUBE HOLDING DEVICE
FDA 510(k)
FDA Class 2
·General Hospital
n.a.
FDA UDI
Karl Storz GmbH & Co. KG·04048551198469·Laryngeal Mirror without handle
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690192961·Femoral Locating Device Bushing 8 deg
Young Specialties
FDA UDI
Young Innovations, Inc.·00843471188224·.022 U/L STD. WELD SIZE #8
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209136469·KIT, BAG O' CATS - BLK/BLK
ELIBRA DYNAMIC KNEE BALANCER
FDA 510(k)
FDA Class 2
·Neurology
Xultan 5.5 Pedicle Screw System
FDA 510(k)
FDA Class 2
·Orthopedic
SILVERSPEED HYDROPHILIC GUIDEWIRE
FDA Adverse Event
Malfunction
·EV3 NEUROVASCULAR·Product code DQX·April 24, 2014
IACCU-CHEK SPIRIT COMBO
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·September 28, 2012
R SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·July 20, 2010
BD ALARIS¿ EXTENSION SET
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·November 24, 2021
UNSPECIFIED BD INFUSION SET
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·December 22, 2022
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