7 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TIVA
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CORELEADER COLLA-PAD MODEL CS 03030
FDA 510(k)
FDA Unclassified
·Unknown
VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR RIFAMPIN
FDA 510(k)
FDA Class 2
·Microbiology
SHILEY
FDA Adverse Event
Injury
·COVIDIEN·Product code JOH·May 29, 2013
ASR ACETABULAR CUPS 54
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD·Product code KWA·June 23, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·September 3, 2008
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