10 results
·
19ms
·
Sources: EU EUDAMED, US FDA
ADRENOCORTICOTROPIN RADIO-IMMUNOASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Novo Surgical Inc.
FDA UDI
NOVO SURGICAL, INC.·00842331129858·jennings mouth gag, standard pattern, large (ad...
CAPIO SLIM SUTURE CAPTURING DEVICE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FHQ·January 27, 2017
TOPTOUCH /OTHER CLIENTS PRIVATE LABELING
FDA 510(k)
FDA Class 1
·General Hospital
TRIHA +
FDA 510(k)
FDA Class 2
·Orthopedic
CAPIO SLIM
FDA Adverse Event
BOSTON SCIENTIFIC·Product code FHQ·February 26, 2018
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 27, 2014
TRIGEN
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JDS·November 14, 2012
PROGRAMMING SOFTWARE
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·September 8, 2010
Optical Access System; 5mm x 100mm and 12mm x 100mm; Model #: CTR03 and CTR73. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.
FDA Enforcement
Class II
·Terminated·Stryker Sustainability Solutions·July 1, 2015