16 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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INTRODUCER ASSEMBLY WITH ROTATOR LOCK
FDA 510(k)
FDA Class 2
·Cardiovascular
Mini-Mono®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR70605191·Mini-Mono-Brackets Roth 'N' .018" 400 Brackets ...
INRATIO
FDA Adverse Event
Malfunction
·HEMOSENSE, INC.·Product code JPA·December 8, 2006
INRATIO
FDA Adverse Event
Malfunction
·HEMOSENSE, INC.·Product code JPA·February 20, 2007
MAGNUM FLOW IRRIGATION SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GLUCANPRO
FDA 510(k)
FDA Unclassified
·Unknown
INRATIO
FDA Adverse Event
Malfunction
·HEMOSENSE, INC.·Product code JPA·January 5, 2007
1ST RESPONSE RESUSCITATOR, INFANT
FDA Adverse Event
Malfunction
·GALEMED CORPORATION·Product code BTM·March 4, 2009
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·March 26, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·September 4, 2014
FAST-CATH HEMOSTASIS INTRODUCER, 4F, 8.5CM SHEATH
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL·Product code DYB·June 11, 2008
PALINDROME EMERALD SPORT PACK Cuffed Dual Lumen Catheter with Pre-curved Shaft and Heparin Coating, REF 8888123411, Size 14.5Fr/Ch (4.85mm) x 23cm. TYCO HEALTHCARE GROUP LP, Mansfield, MA 02048. --- NOTE: Both the "sport pack" and "kit" package configurations include the catheter, Venetrac insertion stylets, pull apart sheath, and other accessories necessary for placement. The Venetrac insertion stylet is an optional accessory. The 510k for the Venetrac accessory is K051584. The 510k for the catheter is K060509.
FDA Recall
Terminated
·Covidien·Product code NYU·September 19, 2008
PALINDROME EMERALD SPORT PACK Cuffed Dual Lumen Catheter with Pre-curved Shaft and Heparin Coating, REF 8888128461, Size 14.5Fr/Ch (4.85mm) x 28cm. TYCO HEALTHCARE GROUP LP, Mansfield, MA 02048. --- NOTE: Both the "sport pack" and "kit" package configurations include the catheter, Venetrac insertion stylets, pull apart sheath, and other accessories necessary for placement. The Venetrac insertion stylet is an optional accessory. The 510k for the Venetrac accessory is K051584. The 510k for the catheter is K060509.
FDA Recall
Terminated
·Covidien·Product code NYU·September 19, 2008
PALINDROME EMERALD Kit - Cuffed Dual Lumen Catheter with Pre-cuffed Shaft and Heparin Coating, REF 8888145070, 14.5 FR/CH (4.85mm) x 28 cm. TYCO HEALTHCARE GROUP LP, Mansfield, MA 02048. --- NOTE: Both the "sport pack" and "kit" package configurations include the catheter, Venetrac insertion stylets, pull apart sheath, and other accessories necessary for placement. The kit includes additional components that would also be available at the hospital, such as a scalpel, wound dressing, etc. The Venetrac insertion stylet is an optional accessory. The 510k for the Venetrac accessory is K051584. The 510k for the catheter is K060509.
FDA Recall
Terminated
·Covidien·Product code NYU·September 19, 2008
PALINDROME EMERALD Kit - Cuffed Dual Lumen Catheter with Pre-curved Shaft and Heparin Coating, REF 8888145069, 14.5 Fr/CH (4.85mm) x 23cm. TYCO HEALTHCARE GROUP LP, Mansfield, MA 02048. --- NOTE: Both the "sport pack" and "kit" package configurations include the catheter, Venetrac insertion stylets, pull apart sheath, and other accessories necessary for placement. The kit includes additional components that would also be available at the hospital, such as a scalpel, wound dressing, etc. The Venetrac insertion stylet is an optional accessory. The 510k for the Venetrac accessory is K051584. The 510k for the catheter is K060509.
FDA Recall
Terminated
·Covidien·Product code NYU·September 19, 2008
Aespire View. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.
FDA Enforcement
Class I
·Ongoing·Datex-Ohmeda, Inc.·October 30, 2024