12 results
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18ms
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Sources: EU EUDAMED, US FDA
MYOGLOBIN RIA TEST KIT
FDA 510(k)
FDA Class 2
·Immunology
ReLine
FDA UDI
Nuvasive, Inc.·00195377068880·RELINE C Screw, 4.0x38mm MA
Solstice Occipito-Cervico-Thoracic System
FDA UDI
Life Spine, Inc.·00190837040758·4.0mm x 38mm SOLSTICE® Poly Screw Assm
COMPACT TOUCH
FDA 510(k)
FDA Class 2
·Radiology
TOTAL PTH IMMUNORADIOMETRIC ASSAY(IRMA) DIAGNOSTIC KIT, MODEL 3KG600
FDA 510(k)
FDA Class 2
·Clinical Chemistry
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·July 9, 2015
HEARTMATE II SYSTEM CONTROLLER
FDA Adverse Event
Malfunction
·THORATEC CORP.·Product code DSQ·January 3, 2013
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 1, 2014
VAPR3 FOOTSWITCH *EA
FDA Adverse Event
Malfunction
·DEPUY MITEK LLC US·Product code HRX·October 3, 2020
Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
FDA Enforcement
Class I
·Ongoing·Zyno Medical LLC·June 18, 2025
smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·March 27, 2024
paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·October 2, 2024