16 results
·
28ms
·
Sources: EU EUDAMED, US FDA
GORE(R) EMBOLIC FILTER
FDA 510(k)
FDA Class 2
·Cardiovascular
Apex
FDA UDI
ORTHOXEL DESIGNATED ACTIVITY COMPANY·05391529586461·Apex Femoral Nail GT Left Ø 12.0 x 480mm
Apex
FDA UDI
ORTHOXEL DESIGNATED ACTIVITY COMPANY·05391529587369·Apex Femoral Nail GT Right Ø 12.0 x 480mm
Apex
FDA UDI
ORTHOXEL DESIGNATED ACTIVITY COMPANY·05391529585563·Apex Femoral Nail PF Right Ø 12.0 x 480mm
Apex
FDA UDI
ORTHOXEL DESIGNATED ACTIVITY COMPANY·05391529583224·Apex Femoral Nail PF Left Ø 12.0 x 480mm
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450235577·
NA
FDA UDI
STRYKER CORPORATION·07613327096583·Elite Straight Attachment
AED
FDA UDI
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.·00848657017824·90 degree Punch blunt 3.5mm left angled
RBM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ROTA-TRACH TRACHEOSTOMY TUBE MODEL ROTA-TRACH
FDA 510(k)
FDA Class 2
·Anesthesiology
N/A
FDA UDI
STRYKER CORPORATION·07613327591965·Elite Q 14 cm straight attachment
NA
FDA UDI
STRYKER CORPORATION·04546540369987·SD/PD Series XL Straight Attachment
TRIDENT HEMISPHERICAL CLUSTER 58MM
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS-MAHWAH·Product code MEH·May 20, 2013
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 26, 2014
TISSUE RETRIEVAL SYSTEM
FDA Adverse Event
Other
·ANCHOR PRODUCTS CO.·Product code GCJ·May 31, 2011
Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format) Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.) Track interproximal decay progression over time Patient education tool
FDA Enforcement
Class II
·Terminated·GA Industries·May 6, 2015