15 results · 21ms · Sources: EU EUDAMED, 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