23 results
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25ms
·
Sources: EU EUDAMED, US FDA
MODIFICATION OF FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAIL)
FDA 510(k)
FDA Class 2
·Orthopedic
CAMLOG
FDA UDI
Preat Corporation·00842092167328·CAMLOG® Screw-Line-compatible 3.3mm Non-Engagin...
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814787·GENUMEDI EXTRA WIDE SILVER SIZE V
Alpha-Tec Systems
FDA UDI
Alpha-TEC Systems, Inc.·00816085020372·CELL-BOND Slides, 1 Well, white background
Iris
FDA UDI
BECKMAN COULTER IRELAND INC.·10837461002321·The tubes are specimen receptacles for body flu...
Navagio
FDA UDI
Kalitec Direct LLC·B07330K0132150·Trial, TLIF, 27L OB CRV 7Deg, 15mm
MINIMED QUICK-SET
FDA Adverse Event
Injury
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·May 14, 2025
SWIVEL ELBOW
FDA 510(k)
FDA Class 2
·Anesthesiology
DBEST HCG 2 IU/ML TEST KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SECURE FLOW
FDA Adverse Event
Injury
·WOO YOUNG MEDICAL INC.·Product code MEB·March 27, 2012
MINIMED QUICK-SET
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·July 7, 2025
OT VERIO TEST STRIPS
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 14, 2013
PRECISION FLOW
FDA Adverse Event
Injury
·VAPOTHERM·Product code BTT·February 21, 2011
IACCU-CHEK SPIRIT
FDA Adverse Event
Malfunction
·DISETRONIC MEDICAL SYSTEMS·Product code LZG·February 20, 2008
MENTOR MEMORYGEL BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·August 23, 2019
LUMENIS PULSE 30H
FDA Adverse Event
Malfunction
·LUMENIS LTD.·Product code GEX·November 12, 2020
LUMENIS PULSE 30H
FDA Adverse Event
Malfunction
·LUMENIS LTD.·Product code GEX·February 17, 2022
LUMENIS PULSE 30H
FDA Adverse Event
Malfunction
·LUMENIS LTD.·Product code GEX·March 30, 2022
LUMENIS PULSE 30H
FDA Adverse Event
Malfunction
·LUMENIS LTD.·Product code GEX·January 13, 2022
smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024