11 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LYPHOCHEK MATERNAL SERUM CONTROL, MODEL 220
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Polystar HK
FDA UDI
Merz Dental GmbH·D7091984594·anteriors; shade D2; mould R 60
BONEFIT HOLLOW SCREW IMPLANTS
FDA 510(k)
FDA Class 2
·Dental
COLLAR BUTTON STYLE VENTURI
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
RIATA ST ACTIVE FIXATION
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·February 28, 2013
ASR ACETABULAR CUPS 48
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·January 28, 2011
XPERT SELF-EXPANDING TRANSHEPATIC STENT SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code FGE·August 6, 2014
INFLATOR KIT 18INFKIT BALLOON
FDA Adverse Event
Injury
·MEDTRONIC XOMED INC.·Product code LRC·August 15, 2014
InterGard Knitted Collagen Coated Vascular prostheses marketed under 510(k) # K964625; InterGard Woven Collagen Coated Vascular prostheses marketed under 510(k} #K970843 and K984294.
FDA Recall
Terminated
·Intervascular S.A.S. Zone Industrielle Athelia I La Ciotat Cedex France·Product code DSY·December 9, 2009
Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, LEFT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-22, b) 41, 44, 47, 50 head, Medium, Item Number 314-02-23, c) 44, 47, 50, 53 head, Large, Item Number 314-02-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-02-25; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024