28 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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POWDER-FREE LATEX EXAMINATION GLOVE STERILE WITH OPTIONAL PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
FDA 510(k)
FDA Class 1
·General Hospital
DP97
FDA UDI
Denplus Inc·D8451001216·DP97, ORI, 2.3 kg
Tandem Diabetes 5mL LL WITH CO-PACKED NEEDLE 26Gx3/8’’
FDA UDI
Exel International·00020221012163·Tandem Diabetes 5mL LL WITH CO-PACKED NEEDLE 26...
artVeneer life
FDA UDI
Merz Dental GmbH·D7092001216·artVeneer life upper anteriors, ITM, B2
Alpine
FDA UDI
Ortho Development Corporation·00822409000456·Alpine Cemented Stem 16 EXT
TEKNO®
FDA UDI
Tekno-Medical Optik-Chirurgie GmbH·04044684022787·MAYO-HEGAR NEEDLE HOLDER 16CM
TruFlex
FDA UDI
ORTHO TECHNOLOGY, INC.·00190730012029·NiTi Thermal U/L 16x22 10 archwires per pack
TruFlex™
FDA UDI
Ortho Organizers, Inc.·00190707126483·TRUFLEX NiTi Thermal U/L 16x25 (10pk)
OsteoMed
FDA UDI
OSTEOMED LLC·00845694052580·PrimaLOK FF Nitinol Guide Wire
GE LOGIQ 700
FDA 510(k)
FDA Class 2
·Radiology
PSK ENDOSCOPE CLEANING SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VERCISE GENUS?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code MHY·August 5, 2025
INTACS PRESCRIPTION INSERTS
FDA Adverse Event
Injury
·ADDITION TECHNOLOGY, INC.·Product code LQE·June 20, 2006
TUFF TT IMPLANT
FDA Adverse Event
Injury
·NORIS MEDICAL LTD·Product code DZE·April 19, 2026
TUFF TT IMPLANT
FDA Adverse Event
Injury
·NORIS MEDICAL LTD·Product code DZE·December 28, 2025
IMPAX CV REPORTING
FDA Adverse Event
Malfunction
·AGFA HEALTHCARE CORP.·Product code LLZ·February 26, 2013
AUTOFEED HUMIDIFICATION CHAMBER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·February 24, 2011
KNIGHTSTAR 330
FDA Adverse Event
Malfunction
·NELLCOR PURITAN BENNETT·Product code CBK·February 22, 2008
INTACS PRESCRIPTION INSERTS
FDA Adverse Event
Injury
·ADDITION TECHNOLOGY, INC.·Product code LQE·April 3, 2006
INTACS CORNEAL IMPLANTS
FDA Adverse Event
Injury
·ADDITION TECHNOLOGY, INC.·Product code LQE·June 20, 2006