15 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
VITEK 2 GRAM POSITIVE ERYTHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE
FDA 510(k)
FDA Class 2
·Microbiology
Caplugs/Evergreen
FDA UDI
CAPlugs·00810044206692·5" CHROM COLUMN COARSE FILTER
Caplugs/Evergreen
FDA UDI
CAPlugs·00810044206685·5" CHROM COLUMN
PALMLIGHT
FDA 510(k)
FDA Class 2
·Dental
BIOHEX ONE-PIECE ONE STAGE DENTAL IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
TI MATRIXMIDFACE SCREW SELF-DRILLING 5MM
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code JEY·March 3, 2017
FREESTYLE AORTIC ROOT BIOPROSTHESIS
FDA Adverse Event
Death
·MEDTRONIC HEART VALVES DIVISION·Product code LWR·December 9, 2018
TI MATRIXMIDFACE SCREW SELF-TAPPING 6MM
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code DZL·September 6, 2017
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·April 29, 2013
SPEEDBAND SUPERVIEW SUPER 7, MODELS 4203
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - SPENCER·Product code MND·May 10, 2011
SYNCHROMED EL
FDA Adverse Event
Malfunction
·RICE CREEK MANUFACTURING·Product code LKK·July 28, 2008
TI MATRIXMIDFACE SCREW SELF-DRILLING 5MM
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code JEY·March 3, 2017
1000317571-2021-00127
FDA Adverse Event
Injury
·CONVATEC LTD·Product code FRO·March 17, 2021
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012