11 results
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19ms
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Sources: EU EUDAMED, US FDA
WHS-1000 WOUND HEALING SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Premier
FDA UDI
PREMIER DENTAL PRODUCTS COMPANY·D6911050156·TRACH TUBE, AIR-LON - SIZE 6
MedGyn Pessary Gellhorn w/drain #2
FDA UDI
MEDGYN PRODUCTS, INC.·M803050156·Pessary ring is used to treat uterine prolapse.
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450141045·
SMART SHIELD NON-STERILE POWDER-FREE PEPPERMINT SCENTED GREEN LATEX EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
SLEEP PAT 200 DEVICE
FDA 510(k)
FDA Class 2
·Anesthesiology
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·April 10, 2013
SYNERGY
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·April 1, 2011
RADIESSE DERMAL FILLER
FDA Adverse Event
Injury
·BIOFORM MEDICAL·Product code LMH·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