9 results
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19ms
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Sources: EU EUDAMED, US FDA
EURO-COLLINS SOLUTION SETS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PERRY SUTURING SET
FDA 510(k)MEVAMATIC 3
FDA 510(k)
FDA Class 2
·Radiology
XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·June 19, 2014
ACCU-CHEK ® MULTICLIX
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·December 24, 2012
ASR ACETABULAR CUPS 48
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·October 19, 2010
Breeze Self-Adhesive Resin Cement, Part Number: N97A, Product Usage: The intended use of this device is for cementation of porcelain, resin, and metalbased inlays, onlays, crowns, bridges and posts. The material is not recommended for use on veneer restorations.
FDA Recall
Terminated
·Kerr/pentron Dba Kerr Corporation And Pentron Clinical·Product code EMA·July 8, 2011
Kerr Maxcem Elite, self-etch/self-adhesive resin cement; Intro Kit Part No. 34417; DMC 0446 Rev 0. Used for cementation of all indirect restorations.
FDA Recall
Terminated
·Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical·Product code MZW·February 22, 2013
BioPlant, a dental bone grafting material. BioPlant has been assigned the product code LYC (Bone Grafting Material, Synthetic) by the FDA and is classified as a Class II Medical Device. BioPlant is a Class II Medical Device. The Device Listing Number is 0007254. BioPlant is a synthetic, multipurpose bone-grafting material intended to be used in dental applications to maintain and restore the bony alveolar ridge in post-extraction tooth-root sockets or after oral surgery, ridge preservation, ridge augmentation, augmentations in the maxillary sinus, repair of periodontal defects and bone voids associated with dental implant placement.
FDA Recall
Terminated
·Kerr Corporation·Product code LYC·October 25, 2012