8 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Models 3543A, 4343A, 2929A and A843B
FDA 510(k)
FDA Class 2
·Radiology
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197452724·McCulloch Blade 1 Hook
80mm long
PDE PHOTODYNAMIC EYE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ROTA-TRACH TRACHEOSTOMY TUBE MODEL ROTA-TRACH
FDA 510(k)
FDA Class 2
·Anesthesiology
ENDOPATH** XCEL* TROCAR
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·July 21, 2011
PELVICOL ACELLULAR COLLIGEN MATRIX
FDA Adverse Event
Injury
·COVIDIEN, FORMERLY TISSUE SCIENCE·Product code FTL·June 12, 2013
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 14, 2014
Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643 11-114644 11-114644S 11-114645 11-114646 11-114647 11-114648 11-114661 11-114662 11-114663 11-114664 11-114664S 11-114665 11-114666 11-114667 11-114668 11-114632 11-114633 Product Usage: Partial Shoulder Replacement.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·December 4, 2019