8 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BIOSIGN HCG-ONE STEP PREGNANCY TEST, ACCUSIGN HCG-ONE STEP PREGNANCY TEST, LIFESIGN HCG-ONE STEP PREGNANCY TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Stainless Steel Tibial Nailing System
FDA UDI
ORTHOFIX SRL·18033509850974·TIBIAL NAIL LOCKING SCREW STERILE THREAD D 6 MM...
MODEL 6/01 UV-B FIXTURE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CIPROFLOXACIN 5 MCG SENSI-DISC
FDA 510(k)
FDA Class 2
·Microbiology
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·February 22, 2013
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·August 1, 2014
PRECISION TEST STRIPS
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE, INC. USA·Product code NBW·January 31, 2011
Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025