14 results
·
18ms
·
Sources: EU EUDAMED, US FDA
NASCOR OXYDOME
FDA 510(k)
FDA Class 1
·Anesthesiology
Gentle Threads
FDA UDI
Biomet Orthopedics, LLC·00880304421042·
Sklar®
FDA UDI
SKLAR CORPORATION·10649111124563·RECAMIER CURETTE BL 12.5" #4
MODEL 5866-34 LEAD ADAPTOR KIT
FDA 510(k)
FDA Class 2
·Cardiovascular
ARTERIAL EMBOLECTOMY CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
APTIMA HPV SCREENING ASSAY
FDA Adverse Event
Injury
·HOLOGIC, INC.·Product code OYB·January 31, 2025
Gentle Threads Interference Screw 9x35mm Full Thread. An interference fixation screw for use in soft tissue reattachment procedures
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·July 8, 2015
LIGAMAX-5MM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·November 23, 2010
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·January 9, 2013
INGENIO
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 1, 2014
Gentle Threads Interference Screw 10x25mm Round Head. An interference fixation screw for use in soft tissue reattachment procedures.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·July 8, 2015
Reprocessed Microline Scissor Tips intended to be used with a reusable hand piece and designed for minimally invasive and open surgical procedures to facilitate cutting, preparation, mobilization, and coagulation of tissue. Model #'s MIC3112, MIC3122, MIC3132, MIC3142, MIC3152, MIC3162.
FDA Enforcement
Class II
·Terminated·STERILMED, INC.·June 8, 2016
Gentle Threads Interference Screw 10x25mm Round Head. An interference fixation screw for use in soft tissue reattachment procedures.
FDA Recall
Terminated
·Biomet, Inc.·Product code HWC·June 3, 2015
Gentle Threads Interference Screw 9x35mm Full Thread. An interference fixation screw for use in soft tissue reattachment procedures
FDA Recall
Terminated
·Biomet, Inc.·Product code HWC·June 3, 2015