3,838 results · 43ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

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