7 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ACE PELVIC STABILIZER
FDA 510(k)
FDA Class 2
·Orthopedic
WONDFO MULTI-DRUG URINE TEST CUP, PANEL
FDA 510(k)
FDA Class 2
·Clinical Toxicology
HANSSON PIN SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
COOK MICROPUNCTURE INTRODUCER SET
FDA Adverse Event
Injury
·COOK MEDICAL INC·Product code DYB·December 16, 2010
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVAMEX·Product code IOR·January 29, 2013
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 15, 2014
Presource kits and trays, labeled as: 1) Cardiovascular Procedure Kit, Catalog Number SAN29ANCC3; 2) Cardiovascular Procedure Kit, Catalog Number SAN29ANCC4; 3) Cardiovascular Procedure Kit, Catalog Number SAN29ANCCL; 4) Cardiovascular Procedure Kit, Catalog Number SAN29ANCCM; 5) Cardiovascular Procedure Kit, Catalog Number SAN33CDCAS; 6) Cardiovascular Procedure Kit, Catalog Number SAN33CDCAT; 7) Cardiovascular Procedure Kit, Catalog Number SANOCAENSA; 8) Cardiovascular Procedure Kit, Catalog Number SCV29ANCCA; 9) Left Heart Kit, Catalog Number SAN73LHKCC; 10) Left Heart Kit, Catalog Number SAN73LHKC6
FDA Enforcement
Class II
·Ongoing·Cardinal Health 200, LLC·July 17, 2024