15 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Dental Unit
FDA 510(k)
FDA Class 1
·Dental
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526550155·GENUMEDI PT KNEE SUP SILVER L EW VI
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04047872666541·PT CONTROL II GREY LEFT XXL
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814695·GENUMEDI SILVER SIZE VI
CASTROVIEJO COLIBRI FORCEPS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896015531·CASTROVIEJO-COLIBRI FORCEPS WITH TYING PLATFORM...
CASTROVIEJO-COLIBRI FORCEPS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896073425·CASTROVIEJO-COLIBRI FORCEPS WITH TYING PLATFORM...
ID NOW COVID-19
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·March 18, 2021
ID NOW COVID-19
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·March 18, 2021
ELI 10 ELECTROCARDIOGRAPH MODEL ELI 10
FDA 510(k)
FDA Class 2
·Cardiovascular
PURPLE/BLACK HEPARIN ASSAY CONTROL
FDA 510(k)
FDA Class 2
·Hematology
MINICAP TRANSFER SET
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·June 3, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 28, 2011
VERSACARE
FDA Adverse Event
Malfunction
·HILL-ROM RITTER·Product code FNL·September 3, 2008
Cobe Optima XP Hollow Fiber Membrane Oxygenator/Reservoir, Sterile, (Standalone Systems) Catalog Numbers 050255500, 050316400, 050412400, 050500000. COBE Cardiovascular, Inc..
FDA Recall
Terminated
·Cobe Cardiovascular, Inc·Product code DTZ·June 26, 2006
Allura system; System Code Description (Model Numbers): Allura Xper FD10C (722001), Allura Xper FD10F (722002), Allura Xper FD10 (722003, 722010, 722026), Allura Xper FD10/10 (722005, 722011, 722027), Allura Xper FD20 (722006, 722012, 722028), Allura Xper FD20 Biplane (722008, 722013), Allura Xper FD20 OR Table (722015, 722023, 722035), Allura Xper FD20 Biplane OR Table (722025), Allura Xper FD20/10 (722029), Allura Xper FD20/15 (722058), Allura Xper FD20/15 OR Table (722059), Allura Xper FD20/20 (722038), Allura Xper FD20/20 OR Table (722039), Cardio Vascular-Allura (722400);
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·May 27, 2026