12 results
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20ms
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Sources: EU EUDAMED, US FDA
DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION, N-DISXXXX..01 WITH N-DISVENT..02
FDA 510(k)
FDA Class 2
·Cardiovascular
BIOGEL NEOTECH II POWDER-FREE NEOPRENE SURGEON'S GLOVE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
WIENER LAB. URICOSTAT ENZIMATICO AA, MODELS 2X50 ML CATALOGUE NO 1840106 AND 4X50 ML CATALOGUE NO 1840105
FDA 510(k)
FDA Class 1
·Clinical Chemistry
INSIGNIA
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·April 22, 2013
DREAMTOME RX SPHINCTEROTOME
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - SPENCER·Product code KNS·April 27, 2011
PROGRAMMING SOFTWARE
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code MUZ·July 3, 2008
UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·March 12, 2012
UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·March 12, 2012
UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·March 12, 2012
FLEXCERA BASE -a Dental resins for the fabrication of artificial teeth
FDA Enforcement
Class II
·Ongoing·Envisiontec US Llc·February 23, 2022
FLEXCERA SMILE -a Dental resins for the fabrication of artificial teeth
FDA Enforcement
Class II
·Ongoing·Envisiontec US Llc·February 23, 2022
Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024