8 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Hi-Torque Vektor, .014, 195cm, Str, Hi-Torque Vektor, .014, 195cm, J, Hi-Torque Vektor, .014, 300cm, Str, Hi-Torque Vektor, .014, 300cm, J
FDA 510(k)
FDA Class 2
·Cardiovascular
MICRO-TOUCH NITRATEX STERILE NITRILE POWDER-FREE BLUE EXAMINATION GLOVES (CHEMOTHERAPY USE)
FDA 510(k)
FDA Class 1
·General Hospital
LEFORTE SYSTEM BONE PLATE & SCREW
FDA 510(k)
FDA Class 2
·Dental
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·September 25, 2013
ULTRACISION** HARMONIC SCALPEL** HAND PIECE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·October 17, 2014
ECLIPSE
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·July 6, 2011
9600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 14, 2013
CooperSurgical lnflatoball Latex Rubber Pessary sold as an individual unit and also part of the lnflatoball Pessary Kit. Product Usage: The lnflatoball Pessary is a single-patient use pessary manufactured from natural latex rubber and is used for treating cystocele and/or rectocele associated with procidentia or prolapse. The inflatoball Pessary contains one (1) Pessary in a double-pocketed sealed clear plastic pouch, one pocket containing the Pessary and one pocket containing the Instructions for Use (IFU).
FDA Enforcement
Class II
·Terminated·CooperSurgical, Inc.·May 17, 2017