21 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SonoStik IV Guide Wire Introducer
FDA 510(k)
FDA Class 2
·Cardiovascular
Simpact Tri-Fin
FDA UDI
Life Spine, Inc.·00190837063139·Final Dilation Tube
INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
FDA Adverse Event
Death
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code MAX·December 18, 2019
SENSICARE POWDER-FREE POLYMER COATED POLYSOPRENE SURGICAL GLOVES, STERILE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
POWDER FREE STERILE LATEX SURGICAL GLOVES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
TRULIANT TIB IMP PSC INSERT SZ 6, 15MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·September 11, 2024
GLIDESHEATH SLENDER NITINOL (CONVENIENCE KIT)
FDA Adverse Event
Malfunction
·TERUMO MEDICAL CORPORATION·Product code DYB·February 21, 2018
MEDFUSION 2001H SYRINGE INFUSION PUMP
FDA Adverse Event
Injury
·MEDEX·Product code FRN·February 27, 2004
SETROX S 53
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code NVN·October 8, 2014
URETEX SUP URETHRAL SUPPORT SYSTEM
FDA Adverse Event
SOFRADIM PRODUCTIONS·Product code OTN·May 16, 2013
TRULIANT
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·July 24, 2024
ADVANCED PATELLA 29M 3 PEG IMPLANT
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·August 15, 2024
TRULIANT TIB IMP PS INSERT SZ 2.5 11MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·April 14, 2023
ADVANCED PATELLA 32MM 3 PEG IMPLANT
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·March 19, 2025
TRULIANT TIB IMP PS INSERT SZ 3.5 9MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·April 19, 2023
GLIDESHEATH SLENDER NITINOL (CONVENIENCE KIT)
FDA Adverse Event
Injury
·TERUMO MEDICAL CORPORATION·Product code DYB·May 4, 2018
GLIDESHEATH SLENDER NITINOL (CONVENIENCE KIT)
FDA Adverse Event
Malfunction
·TERUMO MEDICAL CORPORATION·Product code DYB·December 16, 2019
TRULIANT PS CEM FEM PS CEM RIGHT SZ 3.5
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·December 6, 2023
ADVANCED PATELLA 35MM 3 PEG IMPLANT
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·January 9, 2024
Precise Treatment Table. To be used as part of radiation therapy treatment process.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·April 17, 2013