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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THERATEST EL-ANTI-TPO AND THERATEST EL-ANTI-THYROGLOBULIN, MODEL 104-119, 103-120
FDA 510(k)
FDA Class 2
·Immunology
3D
FDA UDI
Rmo, Inc.·00885797100153·3D LING ARCH ASST 30
TSRH SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code NKB·October 26, 2017
TSRH SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code NKB·October 26, 2017
ART BICARBONATE FOR HEMODIALYSIS, ART BICARBONATE LIQUID FOR HEMODIALYSIS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
REACH FEMORAL COMPONENT
FDA 510(k)
FDA Class 2
·Orthopedic
TSRH SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code NKB·March 6, 2019
TSRH SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code NKB·August 24, 2016
TSRH SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·May 10, 2016
NON AC-POWERED PATIENT LIFT
FDA Adverse Event
Malfunction
·UNKNOWN·Product code FSA·May 2, 2013
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·September 15, 2014
GREENLIGHT ADDSTAT
FDA Adverse Event
Malfunction
·AMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·April 26, 2011
5.0MM TI SCHANZ SCREW WITH DUAL CORE 45MM THREAD/190MM
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code NKB·May 11, 2018
SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2
FDA Enforcement
Class II
·Ongoing·Baxter Healthcare Corporation·January 28, 2026
Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018