13 results
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25ms
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Sources: EU EUDAMED, US FDA
BD PhaSeal Optima Connecting Set (C83-O); BD PhaSeal Optima Spike Set (C180-O)
FDA 510(k)
FDA Class 2
·General Hospital
Aspire Compact Toothbrush
FDA UDI
SAFCO DENTAL SUPPLY CO.·10810063755703·Aspire Compact Toothbrush, ultra compact head, ...
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780455677·Integra® Jarit® Cobb Style Osteotome, Curved
N/A
FDA UDI
BIOMET MICROFIXATION, INC·00841036037109·
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197390798·Adaptor f. Fiberlight cable, PENTAX
facing...
Evolve
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215002640·
G-LIGHT
FDA 510(k)
FDA Class 2
·Dental
BD FlowSmart Set
FDA 510(k)
FDA Class 2
·General Hospital
EGIA ULTRA UNIVERSAL SHORT STAPLER
FDA Adverse Event
Injury
·UNITED STATES SURGICAL·Product code GDW·September 9, 2011
ACTIVA
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·November 14, 2014
ACCU-CHEK ® AVIVA PLUS TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·July 26, 2013
ROCHE CARDIAC TROP T
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code MMI·December 11, 2018
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013