22 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AXS Vecta Aspiration System
FDA 510(k)
FDA Class 2
·Cardiovascular
EasyNet
FDA UDI
CADWELL INDUSTRIES, INC.·00840067100509·Multi Purpose
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319741313·Rosen Pick curved 6-1/2" (16.5 cm), curved 1.5 ...
Ophthalmic Retractor
FDA UDI
KATENA PRODUCTS, INC.·00841668101094·HELVESTON "BIG BARBIE" RETRACTOR 9MM
LinkBio Instrument
FDA UDI
Link Bio Corp·00810022402696·Guide Rod, Tibial Cone D12/L120
MAC 800 RESTING ECG ANALYSIS SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
DENTACENTER/EXPEDITION, MODEL SAF-430
FDA 510(k)
FDA Class 1
·Dental
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·July 20, 2020
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·November 3, 2022
VIDAS® TROPONIN I ULTRA
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code MMI·July 31, 2018
VIDAS® TROPONIN I ULTRA
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code MMI·July 31, 2018
VIDAS® TROPONIN I ULTRA
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code MMI·August 1, 2018
POSITION PRO
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNM·October 6, 2008
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011
DURAGEN DURAL GRAFT MATRIX
FDA Adverse Event
Injury
·INTEGRA LIFESCIENCES CORP.·Product code GXQ·June 21, 2013
METRIX AIR
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH, INC.·Product code NBW·August 7, 2019
OT ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN, INC.·Product code NBW·January 2, 2007
INRATIO PT/INR TEST STRIPS
FDA Adverse Event
Injury
·ALERE SAN DIEGO, INC·Product code GJS·July 14, 2017
VIDAS® TROPONIN I ULTRA
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code MMI·July 31, 2018
VIDAS® TROPONIN I ULTRA
FDA Adverse Event
Malfunction
·BIOMERIEUX SA·Product code MMI·July 31, 2018