12 results
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32ms
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Sources: EU EUDAMED, US FDA
T.O.P. 2000 (TOMOGRAPHIC ORIENTATED PLANNING)
FDA 510(k)
FDA Class 2
·Radiology
GC Initial™
FDA UDI
Gc America Inc.·15400556703691·GC Initial™ MC/Paste Opaque Classic Line PO-CL ...
GC Initial™
FDA UDI
Gc America Inc.·J0228702211·GC Initial™ MC/Paste Opaque Classic Line PO-CL ...
Adult Silicone Mask 4-5+ w/o Multi-Func Mask Cover
FDA UDI
Laerdal Medical AS·07045432033946·Laerdal Silicone Masks are intended to be used ...
FMP METAL/METAL ACETABULAR INSERT, 499-28,449-34, 499-38
FDA 510(k)
FDA Class 3
·Orthopedic
syngo.CT Cardiac Planning
FDA 510(k)
FDA Class 2
·Radiology
ACCU-CHEK ® AVIVA PLUS TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·June 12, 2014
ONE TOUCH PING GLUCOSE MANAGEMENT SYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORP.·Product code LZG·October 1, 2010
ENDOPATH** ETS FLEX45
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·December 12, 2012
EnVision FLEX/HRP visualization reagent found in the following kits: EnVision FLEX, High pH (Link) EnVision FLEX+, Mouse, High pH (Link) EnVision FLEX Mini Kit, High pH (Link) EnVision FLEX, High pH (Dako Omnis) Multi-component, sealed package. For in vitro diagnostic use.
FDA Enforcement
Class II
·Terminated·Dako North America Inc.·November 11, 2015
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) AIRE-CUF TRACHY TUBE 6.0MM MID-RANGE , Product Code/List Number/Item Code 750160; b) AIRE-CUF TRACHY TUBE 7.0MM MID-RANGE , Product Code/List Number/Item Code 750170; c) AIRE-CUF TRACHY TUBE 8.0MM MID-RANGE , Product Code/List Number/Item Code 750180
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024