15 results
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37ms
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Sources: EU EUDAMED, US FDA
ELUAID
FDA 510(k)
FDA Class 1
·Hematology
SmartScreener-Plus2 Screener Launch
FDA UDI
INTELLIGENT HEARING SYSTEMS CORP.·00817020020822·
Sphero Attachment
FDA UDI
Preat Corporation·00842092113950·Sphero Block Abutment Astra 3.0 x 2mm (2.5mm Ball)
Bioplate®
FDA UDI
Bioplate, Inc.·M3848120020·Y Plate - Ø1.5 mm - 5 hole - 18 mm
Ocata Anterior Cervical System
FDA UDI
Kalitec Direct LLC·B07308K0120020·Driver Shaft, Final Tighten
CosmoLock Pedicle Screw System
FDA UDI
Kalitec Direct LLC·B07311K0120020·T-Handle, T25, Screw Height Adjuster
Bioplate®
FDA UDI
Bioplate, Inc.·M384812002CP1·Y Plate - Ø1.5 mm - 5 hole - 18 mm
Bioplate®
FDA UDI
Bioplate, Inc.·M384812002US0·Y Plate - Ø1.5 mm - 5 hole - 18 mm
CAROTID COIL
FDA 510(k)
FDA Class 2
·Radiology
VIKING OPTIMA GUIDING CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
ADAPTER HUMIDIFIER 120/CS
FDA Adverse Event
Malfunction
·CAREFUSION·Product code BTT·August 19, 2013
PENTARAY® NAV HIGH-DENSITY MAPPING CATHETER
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code MTD·May 15, 2014
CONSULTA CRT-D
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NIK·October 31, 2012
PUMP MMT-715LNAL PRDGM INS V2.1 CL EN
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code LZG·August 17, 2010
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