23 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ANTHEM Fracture System
FDA 510(k)
FDA Class 2
·Orthopedic
Comprehensive® Reverse Shoulder
FDA UDI
Biomet Orthopedics, LLC·00880304677173·
RESPIRATORY HUMIDIFIER , HEATED DELIVERY SYSTEM, ADAPTOR, MODELS MR880, RT241, 900MR441
FDA 510(k)
FDA Class 2
·Anesthesiology
INAREX, MODEL 2D-LX
FDA 510(k)
FDA Class 2
·Physical Medicine
BD¿ SYRINGE WITH BD LUER-LOK¿ TIP
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·December 8, 2017
PLUM A+ WIRELESS SIN
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·October 15, 2014
UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·July 27, 2011
ACCU-CHEK ® MULTICLIX
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·June 20, 2013
PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code FTL·April 5, 2021
PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAW·April 5, 2021
COMP PRIMARY STEM 9MM MICRO
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code MBF·January 15, 2018
Comprehensive Reverse Shoulder System, Item numbers 115394, 115395, 115396, 115398, 180550, 180551, 180552, 180553, 180554, 180555, 180556, 180557, 180558, 180559, 180560, 180562 - Product Usage: indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthroplasty and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff The patient must anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·December 23, 2020
Comprehensive Reverse Shoulder System, Item numbers 115394, 115395, 115396, 115398, 180550, 180551, 180552, 180553, 180554, 180555, 180556, 180557, 180558, 180559, 180560, 180562 - Product Usage: indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthroplasty and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff The patient must anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.
FDA Recall
Terminated
·Biomet, Inc.·Product code KWS·November 25, 2020
BD FACSLyric Flow Cytometer, 3-Laser 12 Color Instrument, REF: 663029, when using BD Trucount Tubes
FDA Recall
Terminated
·Becton, Dickinson and Company, BD Biosciences·Product code OYE·August 19, 2019
BD FACSLyric Flow Cytometer, 2-Laser 6 Color Instrument, REF: 662876, when using BD Trucount Tubes
FDA Recall
Terminated
·Becton, Dickinson and Company, BD Biosciences·Product code OYE·August 19, 2019
BD FACSLyric Flow Cytometer, 2-Laser 6 Color Instrument, REF: 651165, when using BD Trucount Tubes
FDA Recall
Terminated
·Becton, Dickinson and Company, BD Biosciences·Product code OYE·August 19, 2019
BD FACSLyric Flow Cytometer, 3-Laser 8 Color Instrument, REF: 654587, when using BD Trucount Tubes
FDA Recall
Terminated
·Becton, Dickinson and Company, BD Biosciences·Product code OYE·August 19, 2019
BD FACSLyric Flow Cytometer, 2-Laser 4 Color Instrument, REF: 662875, when using BD Trucount Tubes
FDA Recall
Terminated
·Becton, Dickinson and Company, BD Biosciences·Product code OYE·August 19, 2019
BD FACSLyric Flow Cytometer, 3-Laser 8 Color Instrument, REF: 662877, when using BD Trucount Tubes
FDA Recall
Terminated
·Becton, Dickinson and Company, BD Biosciences·Product code OYE·August 19, 2019
BD FACSLyric Flow Cytometer,3-Laser 10 Color Instrument, REF: 659180 and 65918001, when using BD Trucount Tubes
FDA Recall
Terminated
·Becton, Dickinson and Company, BD Biosciences·Product code OYE·August 19, 2019