9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Stable-C Interbody System
FDA 510(k)
FDA Class 2
·Orthopedic
ELMED
FDA UDI
ELMED INCORPORATED·00842180184350·3.2MM CANNULA, STRYKER SPEED LOCK STYLE, DUAL R...
Sonosite PX Ultrasound System
FDA 510(k)
FDA Class 2
·Radiology
TRUSCOPE SERIES PATIENT MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.35 WIRE, 12, STERILE
FDA Adverse Event
Malfunction
·OLYMPUS WINTER & IBE GMBH·Product code GCP·August 11, 2021
SYSTEM 1000
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code KDI·September 1, 2011
ENDOPOUCH RETRIEVER SPEC BAG
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC·Product code GCJ·August 11, 2008
MINICAP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·July 17, 2013
Revogene, Catalog no. 610210. IVD test instrument
FDA Enforcement
Class II
·Ongoing·Meridian Bioscience Inc·August 3, 2022