54 results
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35ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Non-sterile, Powder Free Nitrile Examination Aloe Vera Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, And Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs and Fentanyl Citrate
FDA 510(k)
FDA Class 1
·General Hospital
OsteoMed
FDA UDI
OSTEOMED LLC·00845694054966·3.5/4.0mm Depth Gauge, Additional Length
\RESENIUS ACCESS FLOW RESERVING CONNECTORS, FRESENIUS STANDALONE ACCCES FLOW RESERVING CONNECTOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL, MODELS 637, 638, 639 (RADIOMETER)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC.(CRM-SYLMAR)·Product code NVY·December 4, 2025
E SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·October 8, 2008
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·August 5, 2011
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·July 2, 2013
BIASURGE® ADVANCED SURGICAL SOLUTION
FDA Adverse Event
Injury
·ROCHAL TECHNOLOGIES LLC·Product code FRO·August 19, 2025
MENTOR SMOOTH ROUND MODERATE PROFILE
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FWM·January 13, 2020
BROSELOW TAPE V3
FDA Adverse Event
Malfunction
·SUNMED GROUP HOLDINGS, LLC DBA AIRLIFE B·Product code OKI·November 19, 2025
INTERSTIM
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code EZW·June 4, 2025
MICRA
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code DYB·February 11, 2026
MEDTRONIC LEAD
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code DXY·May 5, 2026
AGILIS NXT INTRODUCER, UNKNOWN
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code DYB·October 3, 2025
MEDTRONIC ICD
FDA Adverse Event
Death
·MEDTRONIC, INC.·Product code DXY·December 23, 2025
SELECTSECURE MRI SURESCAN
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code NVN·November 19, 2025
UNKNOWN COOL TIP ELECRTRODE
FDA Adverse Event
Malfunction
·COVIDIEN·Product code GEI·December 16, 2025
TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED¿
FDA Adverse Event
Injury
·ABBOTT MEDICAL, COSTA RICA LTDA·Product code OAE·September 24, 2025
SELECTSECURE MRI SURESCAN
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code NVN·November 19, 2025