11 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
KARL STORZ INSULATED BIOPSY FORCEPS, GRASPING/DISSECTING FORECPS, FLEXIBLE FORCEPS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ACCESSORY SET FOR CO2 LASER BRONCHOSCOPY INSTRUMEN
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
EMIT (R) II PHENCYCLIDINE ASSAY
FDA 510(k)
FDA Unclassified
·Unknown
FRESENIUS DIALYSIS DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·FRESENIUS MEDICAL CARE-NORTH AMERICA·Product code KDI·May 16, 2008
OXF UNI TIB TRAY SZ D LM PMA
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code NRA·October 16, 2023
SHELL POROUS WITH CLUSTER HOLES
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code LPH·May 26, 2017
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·UNKNOWN·Product code IOR·February 5, 2013
VITALITY 2
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·January 3, 2011
RX CYTOLOGY BRUSH
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - SPENCER·Product code FDX·July 18, 2014
Colonoscope, Model Number PCF-H190DL.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·March 6, 2024
KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE
FDA 510(k)
FDA Class 2
·Neurology