10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Oral/Enteral Syringe with ENFit connector
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Sklar®
FDA UDI
SKLAR CORPORATION·10649111193439·REYNOLDS DISS SCIS STR SERR 7"
WHITE MOUNTAIN IMAGING
FDA registration
WHITE MOUNTAIN IMAGING·1 product·🇺🇸 United States
PENUMBRA DDC CATHETERS
FDA 510(k)
FDA Class 2
·Cardiovascular
RAICHEM LDL-CHOLESTEROL DIRECT REAGENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·August 25, 2011
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS INC.·Product code CBK·August 6, 2014
MINICAP TRANSFER SET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·July 12, 2013
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·November 7, 2018
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025