17 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Arm Blood Pressure Monitor (HH-802CB, HH-802EB, HH-805CB, HH-812CB, HH-808CL, HH-808EL)
FDA 510(k)
FDA Class 2
·Cardiovascular
Vilex Power Accessory
FDA UDI
VILEX IN TENNESSEE, INC.·00841731122315·KWire .094 x 9" (2.4x225mm)
M/DN®
FDA UDI
Zimmer, Inc.·00889024045460·
M/DN®
FDA UDI
Zimmer, Inc.·00889024045422·
M/DN®
FDA UDI
Zimmer, Inc.·00889024045439·
M/DN®
FDA UDI
Zimmer, Inc.·00889024045453·
M/DN®
FDA UDI
Zimmer, Inc.·00889024045477·
M/DN®
FDA UDI
Zimmer, Inc.·00889024045446·
M/DN®
FDA UDI
Zimmer, Inc.·00889024045408·
M/DN®
FDA UDI
Zimmer, Inc.·00889024045415·
PowerKnot High Strength Sutures
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Bolt Intravascular Lithotripsy (IVL) System
FDA 510(k)
FDA Class 2
·Cardiovascular
NA
FDA UDI
aap Implantate AG·04042409194177·L-Plate WSP 2.5, 2/5, L, L 15/57
VITALITY EL
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS, INC·Product code LWS·November 11, 2008
PINNACLE MTL INS NEUT40IDX56OD
FDA Adverse Event
Malfunction
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·September 19, 2011
ACCU-CHEK ® COMPACT TEST DRUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·July 30, 2013
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