13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SINCLAIR SEBORRHEA EMULSION
FDA 510(k)
FDA Unclassified
·Unknown
Premier
FDA UDI
PREMIER DENTAL PRODUCTS COMPANY·D6911050158·TRACH TUBE, AIR-LON - SIZE 7
TruForm
FDA UDI
Rmo, Inc.·00885797099709·MX MLR BDS R/L SE ASIA ASST100
MedGyn Pessary Gellhorn w/drain #4
FDA UDI
MEDGYN PRODUCTS, INC.·M803050158·Pessary ring is used to treat uterine prolapse.
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450482872·
VEINLASE, MODEL E50-K8-B5, SPECTRUM K8, MODEL E50-K8-B9
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
THROMBOMAX-HS WITH CALCIUM, MODEL T6540
FDA 510(k)
FDA Class 2
·Hematology
IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08)
FDA Adverse Event
Malfunction
·AGFA HEALTHCARE CORP·Product code LLZ·September 17, 2013
INSIGNIA
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·April 10, 2013
TOTALCARE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·April 5, 2011
LAUNCHER 6F (JL3.5)
FDA Adverse Event
Injury
·MEDTRONIC VASCULAR·Product code DQY·May 21, 2008
Tracheostomy Tubes, Air Lon Nylon, item number 1050150 size 3, item number 1050152 size 4, item number 1050154 size 5, item number 1050156 size 6, item number 1050158 size 7, and item number 1050160 size 8.
FDA Recall
Terminated
·Premier Dental Products Co·Product code JOH·August 5, 2004
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012