10 results
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35ms
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Sources: EU EUDAMED, US FDA
VASCULAB BI-DIRECTIONAL DOPPLER, #D10
FDA 510(k)
FDA Class 2
·Radiology
ACUMED
FDA UDI
Acumed LLC·10806378044588·7.0mm Cannula Left Assy
ULTRATEMP FIRM, FAST AND REGULAR SET
FDA 510(k)
FDA Class 2
·Dental
WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR
FDA 510(k)
FDA Class 2
·Dental
10MM/130 DEG TI CANN TFNA 170MM - STERILE
FDA Adverse Event
Injury
·SYNTHES MONUMENT·Product code HSB·December 11, 2015
V60 VENTILATOR
FDA Adverse Event
Malfunction
·RESPIRONICS CALIFORNIA, INC.·Product code MNT·May 8, 2014
CARTO® 3 SYSTEM
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL)·Product code DQK·October 22, 2012
TRIATHLON AR FEMORAL ALIGNMENT GUIDE
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS MAHWAH·Product code LXH·August 4, 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
Access Immunoassay Systems (1) Access 2 Immunoassay Analyzer (81600N); (2) Access 2 Immunoassay Analyzer, Refurbished (386220); (3) Access 2 Immunoassay Analyzer, Refurbished (A65531) ; and (4) Access 2 Section, DxC 600i Packaged(A25640).
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·March 22, 2023