64 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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LUOFUCON Silicone Ag foam dressing
FDA 510(k)
FDA Unclassified
·Unknown
X-CORE
FDA UDI
Nuvasive, Inc.·00887517424228·X-CORE 2 Ti Core, Ø16x16-22mm
OsteoMed
FDA UDI
OSTEOMED LLC·00845694035668·Cannulated Screwdriver Shaft, 6.5mm/7.3mm
MIRABAY
FDA UDI
Mirabay Orthodontics Corp.·05061075022729·KLEOS PSL METAL MBT 022 UL45 HK PK5 UNI
LEONE SPA
FDA UDI
LEONE SPA·08033707016984·CALIBRA 1ST MOLAR BANDS n.LR 22
NISUS NEGATIVE PRESSURE WOUND THERAPY PUMP, NISUS NPWT CANISTER 250-ML, NISUS NPWT CANISTER 500-ML, CORK MEDICAL PRODUCT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine Pregnancy Test Cassette, Wondfo One Step HCG Urine Pregnancy Test Midstream
FDA 510(k)
FDA Class 2
·Clinical Chemistry
GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·October 22, 2020
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·X Series®, R Series®, AED Pro®, AED 3 BLS Professional Defibrillators, Pro-Padz Radiotransparent Electrode, SurePower
AXIOM ARTIS ZEEGO
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE, BUSINESS AREA ADVANCED THERAPY·Product code IZI·September 15, 2016
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 10, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 13, 2011
HYDROTHERMABLATOR CONSOLE UNIT
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code MNB·September 12, 2008
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·CPR Uni-padz Electrode
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·MFC-CPRD Cable Assembly used with X Series and R Series Device
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·X Series®/Propaq MD device
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·AED 3 BLS Device
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·X Series/Propaq MD
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·R Series
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·Zoll R Series