10 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ULTRA SURGICAL GOWN & FLUID BARRIER SURGICAL GOWN
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
3D
FDA UDI
Rmo, Inc.·00885797100191·3D QUADACTION MAN 11 ASST OF 4
CAPNOPROBE SL, MODEL 2000
FDA 510(k)
FDA Class 2
·Anesthesiology
RIGID GAS PERMEABLE CONTACT LENS
FDA 510(k)
FDA Class 2
·Ophthalmic
LINEAR? ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·November 7, 2025
FORCEPS 3711040 WEIL BLAKESLEY SZ0 45UP
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED, INC.·Product code KAE·April 26, 2013
PIPELINE EMBOLIZATION DEVICE
FDA Adverse Event
Injury
·COVIDIEN·Product code DQY·September 5, 2014
AU681-02E CHEMISTRY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER MISHIMA K.K.·Product code JJE·May 6, 2011
Stryker End Cap T2 Tibia +10 mm Catalog Number: 18220010S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
FDA Enforcement
Class II
·Terminated·Stryker GmbH·June 24, 2020
a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS25; b) PEDIATRIC TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS30; c) PEDIATRIC TRACHEOSTOMY TUBE 3.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS35; d) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS40; e) PEDIATRIC TRACHEOSTOMY TUBE 4.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS45; f) PEDIATRIC TRACHEOSTOMY TUBE 5.0mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS50; g) PEDIATRIC TRACHEOSTOMY TUBE 5.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS55
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024