76 results
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28ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with penicillin in the dilution range of 0.015-32 ug/mL
FDA 510(k)
FDA Class 2
·Microbiology
PILLING
FDA UDI
TELEFLEX INCORPORATED·24026704515299·
InSitu Hip System
FDA UDI
NEXTSTEP ARTHROPEDIX, LLC·00810030810209·Femoral Head, 32mm, 0mm, Ceramic
EVEREST® Spinal System
FDA UDI
VB Spine LLC·10888857398559·Tapered Tap, Size 3.5 mm
WILLI GELLER CREATION ZI PORCELAIN
FDA 510(k)
FDA Class 2
·Dental
NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL Interfixated System, Brigade Hyperlordotic System, Brigade Standalone System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, Cohere Thoracolumbar Interbody System, Modulus XLIF Interbody System, Modulus TLIF Interbody System, Modulus ALIF System
FDA 510(k)
FDA Class 2
·Orthopedic
SWAN-GANZ BIPOLAR PACING CATHETER FOR SVC INSERTION
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES, PR·Product code DYG·November 10, 2008
ASR ACETABULAR IMPLANT 50
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·September 12, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·July 23, 2013
Pilling LOWSLEY PROSTATIC TRACTOR STR, REF 243201; retractor
FDA Recall
Open, Classified
·TELEFLEX LLC·Product code GAD·May 25, 2023
Pilling LOWSLEY PROSTATIC TRACTOR STR, REF 243201; retractor
FDA Enforcement
Class II
·Ongoing·TELEFLEX LLC·July 12, 2023
BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JKA·December 8, 2025
BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH PRE-ATTACHED HOLDER
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code FMI·October 15, 2025
BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code FMI·December 3, 2025
BD VACUTAINER® SERUM
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JKA·January 26, 2026
BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code FMI·November 17, 2025
BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code FMI·November 20, 2025
BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JKA·December 8, 2025
BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code JKA·December 8, 2025
BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO (FRANKLIN LAKES)·Product code FMI·December 8, 2025