15 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OsteoCentric Dental Implant System
FDA 510(k)
FDA Class 2
·Dental
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772777594·LUMBAMED BASIC DORSAL STAY WM SILVER II
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772777440·LUMBAMED PLUS FLEX PAD WM SILVER II
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668114223·LASIK CANNULA FLATTENED 25GA
N/A
FDA UDI
BIOMET MICROFIXATION, INC·00841036035549·
Restore
FDA UDI
KEYSTONE DENTAL, INC.·D768R23024202K0·Quick Abutment
MAVEN PRO
FDA 510(k)
FDA Class 2
·Radiology
FYRELINK
FDA 510(k)
FDA Class 2
·Radiology
ENDOTAK DSP
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·January 4, 2011
FG 6301 DUAL CHNL VOL INF PUMP2M8064 SERVICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FRN·November 17, 2008
UNICEL ® DXC600I SYNCHRON ® ACCESS ® CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code MMI·September 1, 2011
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 16, 2013
INHANCE
FDA Adverse Event
Injury
·DEPUY IRELAND - 3015516266·Product code PHX·May 28, 2026
INHANCE
FDA Adverse Event
Injury
·DEPUY IRELAND - 3015516266·Product code PHX·May 28, 2026
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025