18 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AmeriWater Heatsan, 3-phase, 208v, 60hz, AmeriWater Heatsan, 3-phase, 460V, 60hz, Ameriwater Heatsan, 3-phase, 575v, 60hz
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814220·GENUMEDI PT SILVER L V
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526550148·GENUMEDI PT KNEE SUP SILVER L EW V
CoRoent
FDA UDI
Nuvasive, Inc.·00887517637499·CoRoent Ant TLIF PEEK, 14x12x28mm 15°
Vilex Power Accessory
FDA UDI
VILEX IN TENNESSEE, INC.·00841731122247·KWire .054x9" (1.4x225mm)
NA
FDA UDI
aap Implantate AG·04042409103032·APS Super Lag Screw 14mm, self-tapping, TL 22, ...
UNICRYL M
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
KRYSTALRAD (ATAL8)
FDA 510(k)
FDA Class 2
·Radiology
T:SLIM G5 SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OYC·October 3, 2018
AEQUALIS REVERSED BASE PLATE TA6V LONG PEG WITH HA
FDA Adverse Event
Injury
·TORNIER S.A.S.·Product code KWS·April 19, 2023
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·February 21, 2014
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·August 9, 2012
ONCOR IMPRESSION PLUS
FDA Adverse Event
Other
·SIEMENS MEDICAL SOLUTIONS USA, INC. - RADIATION ONCOLOGY·Product code IYE·May 28, 2013
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·June 28, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·September 3, 2008
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·July 23, 2012
INTERSTIM II
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·March 15, 2013
R-F IM NAIL 10MMDX48CM LG, 11MMDX42CM, 11MMDX44CM, 11MMDX46CM LG, 11MMDX48CM LG, 12MMDX46CM LG, 12MMDX48CM LG, 13MMDX40CM, 13MMDX42CM, 13MMDX44CM, 13MMDX46CM LG, 13MMDX48CM LG, 14MMDX34CM, 14MMDX36CM, 14MMDX38CM, 14MMDX40CM, 14MMDX42CM, 14MMDX44CM, 14MMDX46CM LG, 14MMDX48CM LG
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·June 21, 2017