16 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SupraSDRM Biodegradable Matrix Wound Dressing
FDA 510(k)
FDA Unclassified
·Unknown
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526781702·LUMBAMED FACET 3 POINT SILVER III
PERFORMER CBP SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
LUMANOSITY CELEBRITY, MODEL 204
FDA 510(k)
FDA Class 2
·Physical Medicine
PHILIPS SONICARE
FDA Adverse Event
Malfunction
·PHILIPS ORAL HEALTHCARE·Product code JEQ·July 24, 2018
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·June 14, 2013
POLYAXIAL SCREW-SOLID 5.5X45MM
FDA Adverse Event
Other
·INTERGRA, MEDINA·Product code KWP·July 5, 2011
IAB : 8 FR - 40 CC
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code DSP·September 11, 2008
ENDO CLIP II
FDA Adverse Event
Malfunction
·DAVIS & GECK CARIBE LTD·Product code FZP·July 25, 2018
PROGREAT
FDA Adverse Event
Injury
·Product code DQO·April 30, 2021
PROGREAT
FDA Adverse Event
Malfunction
·Product code DQO·May 28, 2021
TERUMO PROGREAT CATHETER
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQO·May 25, 2022
Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 16CM (0.021), REF/Product Code RM*RS6F16PA, STERILE, Rx ONLY
FDA Enforcement
Class II
·Terminated·Terumo Medical Corp·December 20, 2017
Glidesheath Slender Hydrophilic Coated Introducer Sheath, 7FR - 16CM (0.021), REF/Product Code RM*RS7F16PA, STERILE, Rx ONLY
FDA Enforcement
Class II
·Terminated·Terumo Medical Corp·December 20, 2017
AquaC UNO H [120V, 60Hz, 1000VA, US-Version - a reverse osmosis unit intended for use with hemodialysis systems. Fresenius Part Number: 24-10VA-1 Vivonic Part Number: G02000970-US
FDA Enforcement
Class II
·Ongoing·Fresenius Medical Care Holdings, Inc.·September 28, 2022
AquaC UNO H [120V, 60Hz, 1000VA, Fresenius US-Version: 24-10VA-1 Vivonic Part Number: G02000970-US
FDA Enforcement
Class II
·Ongoing·Fresenius Medical Care Holdings, Inc.·August 3, 2022