12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Sentinella 102; Sentinella 102 Horus
FDA 510(k)
FDA Class 1
·Radiology
V.A.C. VERAFLO CLEANSE DRESSING SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
D-CARIE, MODEL N121-M1
FDA 510(k)
FDA Class 2
·Dental
TRUERESULT
FDA Adverse Event
Malfunction
·NIPRO DIAGNOSTICS, INC.·Product code NBW·March 21, 2013
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·June 24, 2022
FUJIFILM BALLOON BS-4
FDA Adverse Event
Injury
·FUJIFILM CORPORATION·Product code FDA·January 14, 2021
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·October 6, 2014
MINI TREK CORONARY DILATATION CATHETER
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code LOX·June 3, 2013
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·June 28, 2011
HUDSON AQUAPAK 601 SW,650 ML,JAPAN
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code BTT·September 6, 2016
BD VACUTAINER® K2E (EDTA) 18.0MG PLUS BLOOD COLLECTION TUBE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·November 18, 2022
PKG, KNOT PUSHER 5MM OPEN, P/N 0250080132 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014