15 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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AESCULAP CESPACE PEEK INTERVERTEBRAL BODY FUSION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Zavation
FDA UDI
Zavation LLC·00842166177321·Z-Link Lumbar Sizer 8 deg, 33mm x 11
Zavation
FDA UDI
Zavation LLC·00842166112308·Z-Link Lumbar Spacer 8deg 33mmx11
NEEDLE 25X1-1/2 RB
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMI·January 29, 2024
NEEDLE 25X1-1/2 RB
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMI·January 29, 2024
NUTRISAFE PUR ENTERAL FEEDING TUBE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MODIFICATION TO: POCKETVIEW ECG SOFTWARE
FDA 510(k)
FDA Class 2
·Cardiovascular
NEEDLE 25X1-1/2 RB
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FMI·December 14, 2024
TI CLICKX LOCKING CAP FOR TI3-D HEAD
FDA Adverse Event
Malfunction
·SYNTHES GMBH·Product code MNH·April 29, 2013
PDS FLEX PLATE
FDA Adverse Event
Injury
·ETHICON INC·Product code NHB·May 10, 2011
J-VAC RESERVOIR
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code GCY·July 25, 2008
NUVASIVE HELIX ACP SYSTEM
FDA Adverse Event
Malfunction
·NUVASIVE, INC.·Product code KWQ·June 1, 2022
OPTETRAK Three Peg Patella, Item Numbers: a) 200-02-26, 26MM; b) 200-02-29, 29MM; c) 200-02-32, 32MM; d) 200-02-35, 35MM; e) 200-02-38, 38MM; f) 200-02-41, 41MM;
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·June 26, 2024
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014
Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/100029229, 100030087, 100041982; CD1233-40/100029230, 100029250, 100029259,100031058, 100059778, 100070017; CD1233-40Q/100029260, 100029271, 100029277, 100031104, 100070089; CD1235-40/100029272, 100029282, 100029311, 100031039, 100059779; CD1235-40Q/100029273, 100029295, 100029312, 100030840; CD1241-40/100046351; CD1241-40Q/100046167; CD2231-40/100029274, 100030110, 100041922; CD2231-40Q/100029275, 100030089, 100041923; CD2233-40/100029147, 100029276, 100029313, 100031066, 100037043, 100048759, 100070007; CD2233-40Q/100029148, 100029263, 100029314, 100031067, 100037044, 100059770, 100070068; CD2235-40/100029149, 100029265, 100029283, 100031029, 100059837; CD2235-40Q/100029239, 100029258, 100029284, 100031030, 100066504; CD2241-40/100046148; CD2241-40Q/100046149; CD2299-40/100056952
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018