15 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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HAYMAX
FDA 510(k)
FDA Class 2
·General Hospital
ArgenPMMA 98x25-B1
FDA UDI
ARGEN CORPORATION, THE·D818120894·Crown And Bridge, Temporary, Resin
AF541
FDA UDI
Respironics, Inc.·00606959038844·AF541 Sizing Gauge
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319704141·Green Tissue Forceps 4" (10cm), T-shape, 10mm w...
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 16, 2025
CALIBRATING MATERIAL, CAL-PAK, BUFFERS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CLASSIX CHEMICAL STERILIZATION INDICATOR
FDA 510(k)
FDA Class 2
·General Hospital
CONTOUR
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE LLC·Product code NBW·December 14, 2012
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·May 20, 2013
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE REHABILITATION EQUIP·Product code ITI·September 26, 2014
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 12, 2011
2.7MM VA-LCP LATERAL DISTAL FIBULA PLATE/4 HOLES/LEFT
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HRS·October 11, 2018
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·August 12, 2016
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·October 1, 2015
Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021