26 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850, IntelliVue 4-Slot module rack FMX-4
FDA 510(k)
FDA Class 2
·Cardiovascular
Zavation
FDA UDI
Zavation LLC·00842166132504·Ti3Z CIF 13mmx15mmx6mm -9 deg
ZAVATION
FDA UDI
Zavation LLC·00842166104594·CIF 13x15, 9 deg, -06
ID NOW COVID-19 ASSAY
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·September 29, 2022
ID NOW COVID-19 ASSAY
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·September 29, 2022
ID NOW COVID-19 ASSAY
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·September 29, 2022
ID NOW COVID-19 ASSAY
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·September 29, 2022
MEDTRONIC STYLET KIT, MODELS 6282, 6293, AND 6254
FDA 510(k)
FDA Class 2
·Cardiovascular
APEX SPINE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ENDOSKELETON TC INTERBODY SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code LXH·March 11, 2026
TM ANKLE PROLONG TIBIAL INSERT SZ 6 +2
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HSN·August 14, 2018
TM ANKLE TIBIAL INSERT COMPONENT SIZE 4
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code ITW·August 9, 2018
ARROW PICC KIT WITH PLACEMENT WIRE
FDA Adverse Event
Injury
·ARROW INTERNATIONAL, INC,·Product code LJS·October 22, 2008
UNICEL® DXC 800 SYNCHRON® SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·August 12, 2011
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 8, 2013
HTR-PMI CT77-210906 RIGHT FRONTAL PARIETAL IMPLANT
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code KKY·October 26, 2021
TRABECULAR METAL TOTAL ANKLE TIBIAL BASE COMPONENT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HSN·April 5, 2018
TRABECULAR METAL TOTAL ANKLE TIBIAL INSERT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HSN·April 5, 2018
TRABECULAR METAL TOTAL ANKLE TALAR COMPONENT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HSN·April 5, 2018
Mighty Bliss Electric Heating Pad, Large (12 x 24 ) Blue Electric Heating Pad, MB-001
FDA Enforcement
Class I
·Ongoing·Whele LLC DBA Perch·November 30, 2022