11 results
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26ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MIDAS TOUCH BIPOLAR FORCEPS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Bayonet Forceps 7.75" (196.9 mm) 0.5 mm Tips Non-Stick Electrosurgical/Bipolar Forceps/Reusable, Model #90-7004 (k) #K982705. The surgical device is package non-sterile into small plastic tubes. Olsen Medical Biopolar Reusable Bayonet Forceps and cords are intended for use in coagulating tissue during surgical procedures.
FDA Enforcement
Class II
·Terminated·PSC Industries Inc·July 18, 2012
Bayonet Forceps 7.75" (196.9 mm) 0.5 mm Tips Non-Stick Electrosurgical/Bipolar Forceps/Reusable, Model #90-7004 (k) #K982705. The surgical device is package non-sterile into small plastic tubes. Olsen Medical Biopolar Reusable Bayonet Forceps and cords are intended for use in coagulating tissue during surgical procedures.
FDA Recall
Terminated
·PSC Industries Inc·Product code GEI·June 1, 2012
BIOPRO BIPOLAR HEAD, MODELS 18130-18152
FDA 510(k)
FDA Class 2
·Orthopedic
Juveno Hip System Femoral Stem, b-ONE Primary Acetabular System Cups
FDA 510(k)
FDA Class 2
·Orthopedic
BIOMET DRIVER CONNECTING SCREW
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code JEY·January 29, 2025
MCGAN - ALLERGAN- BREAST IMPLANT
FDA Adverse Event
Malfunction
·MCGHAN/INAMED CORP·Product code FWM·February 22, 2013
SYMBIQ DUAL CHANNEL
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·July 24, 2014
METRICIDE OPA PLUS
FDA Adverse Event
Injury
·ALDEN MEDICAL LLC·Product code MED·February 4, 2011
BIOMET DRIVER CONNECTING SCREW
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code JEY·January 29, 2025
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM UNCUFFED , Product Code/List Number/Item Code 60P025; b) PAED. TRACHEOSTOMY TUBE 3.0MM UNCUFFED , Product Code/List Number/Item Code 60P030; c) PAED. TRACHEOSTOMY TUBE 3.5MM UNCUFFED , Product Code/List Number/Item Code 60P035; d) PAED. TRACHEOSTOMY TUBE 4.0MM UNCUFFED , Product Code/List Number/Item Code 60P040; e) PAED. TRACHEOSTOMY TUBE 4.5MM UNCUFFED , Product Code/List Number/Item Code 60P045; f) PAED. TRACHEOSTOMY TUBE 5.0MM UNCUFFED , Product Code/List Number/Item Code 60P050; g) PAED. TRACHEOSTOMY TUBE 5.5MM UNCUFFED , Product Code/List Number/Item Code 60P055
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024