15 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TECHMEDIA BONE STAPLE
FDA 510(k)
FDA Class 2
·Orthopedic
Bioplate®
FDA UDI
Bioplate, Inc.·M3848135670·CUSTOM MODULE INSERT - NEURO
SYNTHES MATRIXMADIBLE PLATE AND SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Dental
Vyntus/SentrySuite Product Line
FDA 510(k)
FDA Class 2
·Anesthesiology
FLOEY CATHETER W TEMP
FDA Adverse Event
Injury
·DEGANIA SILICONE LTD·Product code DRF·October 17, 2017
FOLEY CATHETER W TEMP
FDA Adverse Event
Malfunction
·DEGANIA SILICONE LTD.·Product code DRF·August 10, 2017
FOLEY CATHETER W TEMP
FDA Adverse Event
Malfunction
·DEGANIA SILICONE LTD.·Product code DRF·August 10, 2017
FOLEY CATHETER W TEMP
FDA Adverse Event
Malfunction
·DEGANIA SILICONE LTD.·Product code KOD·July 7, 2017
SMR HUMERAL HEAD Ø42 MM
FDA Adverse Event
Injury
·LIMACORPORATE SPA·Product code KWT·December 12, 2019
ATTAIN ABILITY PLUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code OJX·October 31, 2012
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONIC, INC.·Product code CBK·March 26, 2014
CAPSURE EPI
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 25, 2010
FOLEY CATHETER W TEMP
FDA Adverse Event
Malfunction
·MMJ SA DE CV (USD)·Product code DRF·November 9, 2018
Terumo TenderFlow Pediatric Arterial Cannulae, 2.0 mm (6Fr) OD, with 1/4 inch vented connector, 9 inch (22.9 cm) long; Catalog no. 813567.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corp·Product code DWF·May 22, 2007
Terumo TenderFlow Pediatric Arterial Cannulae, 2.0 mm (6Fr) OD, with 1/4 inch vented connector, 9 inch (22.9 cm) long; Catalog no. 813567. The TenderFlow (TM) Pediatric Arterial Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DWF·October 16, 2008