12 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
SKINTACT AND VARIOUS OTHER TRADENAMES
FDA 510(k)
FDA Class 2
·Cardiovascular
CONMED
FDA UDI
Conmed Corporation·10845854009468·CYLINDRICAL BUR, LONG, 3 X 4 MM
LIPASE-ESTERASE, ENZYMATIC, PHOTOMETRIC, LIPASE
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code CHI·March 4, 2011
SYNCHRON VANCOMYCIN REAGENT
FDA Adverse Event
BECKMAN COULTER INC.·Product code LEH·June 10, 2011
HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.TA
FDA 510(k)
FDA Class 2
·Immunology
MOTOR-DRIVE MANIPULATOR MM-89
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SYNCHRON LX 20 PRO CLINICAL SYSTEMS
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·June 8, 2011
GMK PRIMARY CEMENTED FIXED FEMORAL COMPONENT
FDA Adverse Event
Injury
·Product code JWH·September 12, 2014
SIZE 1-3 KEEL PUNCH
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·May 3, 2013
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code IOR·September 16, 2014
ADVANTAGE SERIES 29
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·May 3, 2011
PROcise XP Wand with Integrated Cable REF EICA8872-01 Product Usage: PLASMA WAND devices are indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including: adenoidectomy, cysts, head, neck, oral, and sinus surgery, mastoidectomy, myringotomy with effective hemorrhage control, nasal airway obstruction by reduction of hypertrophic nasal turbinates, nasopharyngeal/laryngeal indications including tracheal procedures, laryngeal polypectomy, and laryngeal lesion debulking, neck mass, papilloma keloids, submucosal palatal shrinkage, submucosal tissue shrinkage, tonsillectomy (including palatine tonsils), traditional uvulopalatoplasty (RAUP), tumors, and tissue in the uvula/soft palate for the treatment of snoring. It is intended for procedures using a conductive media, such as normal saline or Ringers lactate.
FDA Enforcement
Class II
·Terminated·ArthroCare Medical Corporation·July 1, 2015