11 results
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27ms
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Sources: EU EUDAMED, US FDA
CELLAMIN
FDA 510(k)
FDA Class 1
·Physical Medicine
Preat
FDA UDI
Preat Corporation·00842092137833·Sphero Block Abutment Astra EV 4.2 x 2mm (1.8mm...
SOPRO 184 CAMERA
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MODIFICATION TO PROVIDENT HIP SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
GEMSTAR PM PMP
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD·Product code FRN·February 21, 2014
ASR ACETABULAR IMPLANT 52
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·October 24, 2012
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code LWS·August 17, 2010
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022
Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
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
Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018