11 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MODEL #527 OPHTHALMIC STRETCHER
FDA 510(k)
FDA Class 2
·General Hospital
TRU UCLA Abutment RP Engaging - Plastic
FDA UDI
STERNGOLD DENTAL LLC·00841549110191·TRU UCLA Abutment RP Engaging - Plastic. The U...
SUTURE RETRIEVER
FDA UDI
Biomet Orthopedics, LLC·00880304563704·
FACTOR XI DEFICIENT PLASMA
FDA 510(k)
FDA Class 2
·Hematology
IMPRA CARBOFLO VASCULAR GRAFT, IMPRA CARBOFLO VASCULAR GRAFTS FOR A-V ACCESS
FDA 510(k)
FDA Class 2
·Cardiovascular
IV SET AN120 W/O BP
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FPA·May 9, 2019
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·July 9, 2015
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·January 9, 2013
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 1, 2014
IV SET AN125 W/O BP 200C
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FPA·August 14, 2019
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