28 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RENASYS GO
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Simpact Tri-Fin
FDA UDI
Life Spine, Inc.·00190837063023·Parallel Pin Offset Guide, Small Screw
Trial Liners (Neutral and 10 degree hooded)
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215038496·
ADVIA IMS GLUCOSE ASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
REALSEAL XT SEALER
FDA 510(k)
FDA Class 2
·Dental
T:SLIM G4 SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code OYC·February 13, 2018
GLIDESHEATH SLENDER NITINOL (CONVENIENCE KIT)
FDA Adverse Event
Malfunction
·TERUMO MEDICAL CORPORATION·Product code DYB·February 21, 2018
ORTHOPEDIATRICS 3.5MM, 80 DEGREE, 4-HOLE, 5 DEGREE FLARE, PLATE
FDA Adverse Event
Injury
·ORTHOPEDIATRICS, INC·Product code HRS·June 29, 2018
URETEX SUP URETHRAL SUPPORT SYSTEM
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION·Product code OTN·May 29, 2013
COLLEAGUE PRE 1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 7, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·September 10, 2008
TRUEMETRIX
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH, INC.·Product code NBW·August 23, 2016
GLUCOSE SENSOR (GLUCOSE SENSOR FREESTYLE LIBRE 14 DAY)
FDA Adverse Event
Injury
·ABBOTT DIABETES CARE INC.·Product code PZE·December 2, 2021
ORTHOPEDIATRICS 3.5MM LOCKING CORTICAL SCREW, T15 HEX, 50MM
FDA Adverse Event
Injury
·ORTHOPEDIATRICS, INC·Product code HWC·June 29, 2018
ORTHOPEDIATRICS 3.5MM LOCKING CORTICAL SCREW, T15 HEX, 50MM
FDA Adverse Event
Injury
·ORTHOPEDIATRICS, INC·Product code HWC·June 29, 2018
ORTHOPEDIATRICS 3.5MM LOCKING CORTICAL SCREW, T15 HEX, 48MM
FDA Adverse Event
Injury
·ORTHOPEDIATRICS, INC·Product code HWC·June 29, 2018
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Injury
·ZOLL MANUFACTURING CORPORATION·Product code MVK·May 6, 2015
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
iCup DX 12 Panel w/ Adulterant, Item No. I-DXA-1127-023
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015