8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AQ HYDROPHILIC DILATORS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
FLEXOR PARALLEL URETERAL ACCESS SHEATH AND DILATORS
FDA Adverse Event
Injury
·COOK INC·Product code EZN·May 21, 2019
GEO Bone Screw System
FDA 510(k)
FDA Class 2
·Orthopedic
COMPUDENT STA
FDA 510(k)
FDA Class 2
·Dental
PROXIMATE** RELOADABLE LINEAR CUTTER WITH SAFTEY LOCK-OUT
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·February 14, 2013
INTEGRATED APD SET W/CASSETTE3-PRONG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·January 14, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 28, 2014
ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026