14 results
·
18ms
·
Sources: EU EUDAMED, US FDA
ULTRAZYME AMYLASE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR87600261·Mand. 2. Bicuspidband left 26
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690120940·A/P FEMORAL CUTTING BLOCK SZ 6
Washbon
FDA UDI
ORMCO CORPORATION·00889989043235·LOWER LEFT SECOND MOLAR WASHBON BAND SIZE 26
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR87600260101·Mand. 2. Bicuspidband left 26
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR87600260051·Mand. 2. Bicuspidband left 26
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR87600260501·Mand. 2. Bicuspidband left 26
iCube II
FDA UDI
Sonova AG·07613275328859·
Tina-quant Cardiac high sensitivity CRP III
FDA 510(k)
FDA Class 2
·Immunology
KOBY SURGICAL INTERNAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
PINNACLE MTL INS NEUT36IDX56OD
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·September 26, 2012
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·INFUSION PUMP·Product code FRN·December 18, 2013
ENDOPATH** XCEL* STABILITY SLEEVE FOR BLADELESS TROCAR
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·July 16, 2010
Brilliance Big Bore Radiology CT with 4.2.0 software version. Model #' 728244 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·March 14, 2018