11 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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3390A REPORTING INTEGRATOR
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Bardia® Foley Catheter Insertion Tray for 30cc Balloon
FDA UDI
C. R. Bard, Inc.·00801741018312·Bardia® Foley Catheter Insertion Tray for 30 cc...
Symmetry Surgical
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482032312·Symmetry® Kit/Set, Micro Surgical, Stainless St...
ACUMED
FDA UDI
Acumed LLC·10806378091094·3.2/1.6 Drill Sleeve
PHACOFRAGMENTATION SYSTEM MEGATRON
FDA 510(k)
FDA Class 2
·Ophthalmic
APPASAMY SLIT LAMP, A1A-11 AND A1A-12 SERIES
FDA 510(k)
FDA Class 2
·Ophthalmic
PLUM XLD LTN AMERICA
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·February 4, 2014
ASR ACETABULAR CUPS 50
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·October 23, 2012
OT ULTRAMINI
FDA Adverse Event
Injury
·LIFESCAN, INC.·Product code NBW·August 16, 2010
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022
PROPONENT DR SL (Model L201)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025