13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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E-CUBE INNO
FDA 510(k)
FDA Class 2
·Radiology
Kerrison
FDA UDI
ELLIQUENCE, LLC·00846338002541·
ID NOW COVID-19
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·September 18, 2020
HYBRID TROCAR SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TGDC-01 PRA
FDA 510(k)
FDA Class 2
·Ophthalmic
SEALING UNIT FROM 5MM TROCARS
FDA Adverse Event
Malfunction
·AESCULAP AG & CO KG·Product code GCJ·June 17, 2015
REDUCING CONVERTER 10/12MM TO 5MM
FDA Adverse Event
Malfunction
·AESCULAP AG & CO KG·Product code GCJ·June 17, 2015
UNKNOWN IMPLANTABLE NEUROSTIMULATOR
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code MRU·May 21, 2013
COBE SPECTRA APHERESIS SYSTEM
FDA Adverse Event
Other
·CARIDIANBCT·Product code LKN·June 1, 2011
PROXIMATE ILS CURVED CIR STAPL
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC·Product code GDW·August 13, 2008
DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
FDA Adverse Event
Injury
·COOK INC·Product code DQO·August 10, 2023
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
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012