13 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HOLLISTER HORIZONTAL DRAIN/TUBE ATTACHMENT DEVICE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Disposable Insulin Pen Needle
FDA 510(k)
FDA Class 2
·General Hospital
REAL TIME HDR (220V), MODEL 132.001; REAL TIME HDR (110V), MODEL 132.002
FDA 510(k)
FDA Class 2
·Radiology
G7 ACETABULAR SHELL
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PBI·August 21, 2019
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·January 14, 2014
SPRINT QUATTRO
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·December 13, 2010
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·December 28, 2012
TAPERLOC COMPLETE MICRO FEMORAL STEM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·August 21, 2019
CLICKX-3D-HEAD F/PEDICSCR POST-OPEN TAN
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code NKB·February 12, 2013
CLICKX PEDICSCR Ø6.2 L50 TAN DBLUE
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code NKB·February 12, 2013
CLICKX-3D-HEAD F/PEDICSCR POST-OPEN TAN
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code NKB·February 12, 2013
CLICKX-3D-HEAD F/PEDICSCR POST-OPEN TAN
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code NKB·February 12, 2013
Covidien Trellis-8 Peripheral Infusion System. Models CVT808015, CVT808025, CVT812015, and CVT812025. The following models are not offered for sale in the US: EVT808015, EVT808025, EVT812015, and EVT812025 Sterile EO. Product Usage: Intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
FDA Enforcement
Class I
·Terminated·Covidien·February 11, 2015