25 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SYNTHES PROXIMAL HUMERAL NAIL
FDA 510(k)
FDA Class 2
·Orthopedic
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·H65810027291·K-FILES 21MM #90
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·10304040093952·Maxima K-Files 21mm
Diamond Orthopedic, LLC
FDA UDI
DIAMOND ORTHOPEDIC, LLC·B551DMD2002729·3.0mm, Cannulated Screw, Self Drilling, Long T...
Medical Facets NC
FDA UDI
MEDICAL FACETS NC LLC·M933MDF20027290·3.0mm Cannulated Screw, Self-Drilling, Long Thr...
QUICK SET
FDA Adverse Event
Malfunction
·UNOMEDICAL UM-D·Product code FPA·February 6, 2026
QUICK SET
FDA Adverse Event
Malfunction
·UNOMEDICAL UM-D·Product code FPA·February 6, 2026
ARROW ULTRA 8 INTRA-AORTIC BALLOON CATHETERS (IABS) 8FR 30CC AND 40CC UNIVERSAL
FDA 510(k)
FDA Class 2
·Cardiovascular
FOCUS
FDA 510(k)
FDA Class 2
·Dental
QUICK SET
FDA Adverse Event
Injury
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·November 11, 2025
MINIMED QUICK-SET
FDA Adverse Event
Injury
·UNOMEDICAL A/S·Product code FPA·October 22, 2024
MINMED QUICK SET
FDA Adverse Event
Injury
·UNOMEDICAL A/S·Product code FPA·August 14, 2024
MINIMED QUICK-SET
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·June 18, 2025
UNKNOWN NEUROSTIMULATOR
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code LGW·March 13, 2013
ASR ACETABULAR CUPS 56
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·February 17, 2011
POLYFLUX S CAPILLARY DIALYZER
FDA Adverse Event
Malfunction
·GAMBRO DIALYSATOREN GMBH·Product code KDI·February 27, 2008
GMK SPHERE TOTAL KNEE SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·November 21, 2025
TECNIS SIMPLICITY
FDA Adverse Event
Injury
·AMO PUERTO RICO MFG. INC.·Product code HQL·August 15, 2025
TECNIS SIMPLICITY
FDA Adverse Event
Injury
·AMO PUERTO RICO MFG. INC.·Product code HQL·September 12, 2025
TECNIS SIMPLICITY
FDA Adverse Event
Injury
·AMO PUERTO RICO MFG. INC.·Product code HQL·September 12, 2025