3,838 results
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43ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GMD UNIVERSAL URINARY INCONTINENCE SLING
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
GMD UNIVERSAL CIRCUMCISION CLAMP, MODEL 200
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
GMD UNIVERSAL SLING
FDA Adverse Event
Injury
·GENERIC MEDICAL DEVICES, INC.·Product code FTL·July 31, 2009
GMD UNIVERSAL URINARY INCONTINENCE SLING, MODEL 1012
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
GMD UNIVERSAL SLING
FDA Adverse Event
Injury
·GENERIC MEDICAL DEVICES, INC.·Product code FTL·July 20, 2009
GMD UNIVERSAL SLING
FDA Adverse Event
Injury
·GENERIC MEDICAL DEVICES, INC.·Product code FTL·July 1, 2009
GMD UNIVERSAL SLING, MODEL PRODUCT CODE 1010 AND 1020
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SYNVISC INJ 8MG/ML (3X2ML)
FDA Adverse Event
Injury
·GENZYME CORP.·Product code MOZ·December 11, 2018
The GMD UNIVERSAL URINARY INCONTINENCE SLING (Code 1010) is supplied sterile and is intended for single patient use only. The GMD Universal Sling is a sterile, single use device for the treatment of female stress urinary incontinence. It is comprised of a polypropylene sheath with a disposable universal low density polyethylene sleeve at each end of attachment of the sling to GMD's single use or reusable trocars. The universal sleeve has three trocar insertion points, the distal and proximal trocar insertion points are for inside-out, bottom-up approaches and a sleeve end trocar insertion point is for outside-in, top-down approaches. The design allows the physician to utilize the device for placement of a polypropylene mesh at the urethra or bladder neck.
FDA Recall
Terminated
·Generic Medical Devices·Product code FTL·February 14, 2011
POLYFLUX L CAPILLARY DIALYZER
FDA Adverse Event
Injury
·GAMBRO DIALYSATOREN GMBH·Product code KDI·September 9, 2011
GMD UNIVERSAL SLING
FDA Adverse Event
Malfunction
·GENERIC MEDICAL DEVICE, INC.·Product code FTL·February 16, 2010
GMD UNIVERSAL SLING
FDA Adverse Event
Injury
·GENERIC MEDICAL DEVICE, INC.·Product code FTL·July 27, 2009
GMD UNIVERSAL SLING
FDA Adverse Event
Malfunction
·GENERIC MEDICAL DEVICE, INC.·Product code FTL·December 20, 2010
GMD UNIVERSAL SLING
FDA Adverse Event
Malfunction
·GENERIC MEDICAL DEVICES, INC.·Product code FTL·September 29, 2010
GMD UNIVERSAL SLING
FDA Adverse Event
Injury
·GENERIC MEDICAL DEVICE, INC.·Product code FTL·July 27, 2009
ATLAS DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC. CRMD·Product code LWS·March 4, 2005
GMD UNIVERSAL SLING
FDA Adverse Event
Malfunction
·GENERIC MEDICAL DEVICES, INC.·Product code FTL·December 17, 2010
GMD UNIVERSAL SLING
FDA Adverse Event
Malfunction
·GENERIC MEDICAL DEVICES, INC.·Product code FTL·November 5, 2009
GMD UNIVERSAL SLING
FDA Adverse Event
Malfunction
·GENERIC MEDICAL DEVICES, INC.·Product code FTL·November 29, 2010
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT: NAIL
FDA Adverse Event
Injury
·ACUMED LLC·Product code LXH·October 25, 2019