10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DSP Implant System
FDA 510(k)
FDA Class 2
·Dental
Costco
FDA UDI
Bernafon AG·05711584089170·CAPTO 3 MNR, 2.4G NFM PB MAC COSTC
VARIAN HIGH ENERGY LINEAR ACCELERATOR
FDA 510(k)
FDA Class 2
·Radiology
SPIDER STANDARD AND ADVANCED
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ARTICULEZE M HEAD 36MM -2
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·August 14, 2013
PINNACLE MTL INS NEUT36IDX52OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code KWA·August 14, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 22, 2014
GYNECARE TVT OBURATOR SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·June 27, 2013
JOHNSON & JOHNSON GENESIS STENT 6X24X80MM
FDA Adverse Event
Malfunction
·CORDIS EUROPA SYSTEM·Product code FGE·July 26, 2007
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) AIRE-CUF TRACHY TUBE 6.0MM MID-RANGE , Product Code/List Number/Item Code 750160; b) AIRE-CUF TRACHY TUBE 7.0MM MID-RANGE , Product Code/List Number/Item Code 750170; c) AIRE-CUF TRACHY TUBE 8.0MM MID-RANGE , Product Code/List Number/Item Code 750180
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024