11 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DD Contrast
FDA 510(k)
FDA Class 2
·Dental
EXPLORER 4D TREATMENT PLANNING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
SPECTRA LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HAKIM INLINE PROGRAMMABLE VALVE SG
FDA Adverse Event
Injury
·CODMAN & SHURTLEFF, INC·Product code JXG·October 22, 2014
GYNECARE TVT RETROPUBIC SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·June 27, 2013
BRAVO
FDA Adverse Event
Malfunction
·GIVEN IMAGING LTD.·Product code FFT·July 13, 2011
BLUNT TIP SCREW, ÿ 4X42MM
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code HSB·December 26, 2024
BLUNT TIP SCREW, ÿ 4X40MM
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code HSB·December 26, 2024
BLUNT TIP SCREW, ÿ 4X40MM
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code HSB·December 26, 2024
GELFOAM
FDA Adverse Event
Injury
·PFIZER, INC. (DEVICE)·Product code LMF·September 18, 2019
MEGADYNE Suction Coagulators, Product Code 004125 (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm)), Product Code 004225 (Suction Coagulator, Handswitching, 8 Fr, 6 inch (15.24cm), Product Code 004325 (Suction Coagulator, Handswitching, 12 Fr, 6 inch (15.24cm)), and Product Code 0041BN (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm), Bulk Non Sterile)
FDA Enforcement
Class II
·Ongoing·Megadyne Medical Products, Inc.·August 9, 2023