17 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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F&P 850 AirSpiral Adult NIV and NHF Circuit Kit
FDA 510(k)
FDA Class 2
·Anesthesiology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772777488·LUMBAMED PLUS FLEX PAD M SILVER I
QUICKANCHOR ETHIBOND
FDA UDI
DEPUY MITEK, LLC·20886705001795·Rotator Cuff QUICKANCHOR Plus Size 2 (5 metric)...
Thino Roth Bracket, .022, Mini Size, LL1
FDA UDI
Astar Orthodontics Inc.·06941673501637·
Votion®
FDA UDI
Ortho Organizers, Inc.·00190707113285·Votion .018 MC U/L 5x5 Hks 345, OS Pad U/L 4/5 SPK
Votion
FDA UDI
ORTHO TECHNOLOGY, INC.·00190730007568·Votion 018 MC U/L 5x5 Hks 345, OS Pad U/L 4/5 SPK
MODIFICATION TO THERMAL ANGEL
FDA 510(k)
FDA Class 2
·Hematology
ALMA LASERS MODIFIED DIODE LASER MODULE WITH SHR TREATMENT MODE FOR USE WITH THE FAMILY OF SOPRANO XL MULTI-APPLICATION
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LASIK
FDA Adverse Event
Injury
·Product code LZS·October 24, 2008
OXFORD UNICOMPARTMENTAL KNEE PHASE 3 RIGHT MEDIAL TIBIAL TRAY SIZE AA
FDA Adverse Event
Injury
·BIOMET UK LTD·Product code NRA·August 15, 2011
MONOPOLAR CURVED SCISSORS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·July 8, 2013
RESTYLANE CONTOUR
FDA Adverse Event
Injury
·Q-MED·Product code LMH·March 22, 2024
CEFALY
FDA Adverse Event
Injury
·CEFALY TECHNOLOGY·Product code PCC·March 9, 2026
CEFALY
FDA Adverse Event
Injury
·CEFALY TECHNOLOGY·Product code PCC·March 9, 2026
ROTCUFF QA+ #2 ETH CP-2 *EA
FDA Adverse Event
Malfunction
·DEPUY MITEK LLC US·Product code HWC·July 24, 2019
paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024
smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024