15 results
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34ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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GINGI-PLAIN CORDS & BRAIDS
FDA 510(k)
FDA Class 1
·Dental
Mrk, Ocular
FDA UDI
KATENA PRODUCTS, INC.·00841668119952·Dell Swivel Toric Mark. W/Rotating Bezel
BoneCam
FDA UDI
MEDLINE INDUSTRIES, INC.·00818614021195·
DIAZYME D-DIMER ASSAY KIT,CALIBRATOR SETAND CONTROL SET
FDA 510(k)
FDA Class 2
·Hematology
VALIDATE CHEM 4 CALIBRATION VERIFICATION TEST SET, MODEL 10004
FDA 510(k)
FDA Class 1
·Clinical Chemistry
THE M-COR MODULAR HIP SYSTEMS
FDA Adverse Event
Malfunction
·MIPRO US, INC·Product code LPH·January 23, 2015
COMP RVRS SHLDR GLNSP STD 36MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·December 11, 2018
COMP PRIMARY STEM 12MM STD
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code MBF·December 11, 2018
COMP RVS TRAY CO 44MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·December 11, 2018
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 15, 2014
VIRTUOSO DR
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL, INC.·Product code LWS·October 31, 2012
TERUMO CDI 500 BLOOD PARAMETER MONITOR
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·August 17, 2010
COMP RVRS 25MM BSPLT HA+ADPTR
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·December 11, 2018
EQUINOXE PRESERVE STEM 6MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code PHX·April 25, 2024
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024