11 results
·
19ms
·
Sources: EU EUDAMED, US FDA
BUCCAL TUBE, BUCCAL ATTACHMENT
FDA 510(k)
FDA Class 1
·Dental
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471150690·K-WIRE - SINGLE TROCAR 0.9mm DIA x 75mm
DISPOSA-SHIELD(TM) INFECTION CONTROL BARRIER
FDA 510(k)
FDA Class 1
·Dental
THE PRECISIONIST
FDA 510(k)
FDA Class 2
·Ophthalmic
OXF UNI TIB TRAY SZ C RM PMA
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code NRA·October 13, 2017
OXF ANAT BRG RT MD SIZE 4 PMA
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code NRA·October 13, 2017
TERUMO ADVANCED PERFUSION SYSTEM 1
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·January 3, 2013
LAMITRODE TRIPOLE SURGICAL LEAD
FDA Adverse Event
Injury
·ADVANCED NEUROMODULATION SYSTEMS·Product code LGW·October 28, 2010
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 1, 2014
DIMENSION EXL 200
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC·Product code JJE·July 23, 2013
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