9 results
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21ms
·
Sources: EU EUDAMED, US FDA
EXPEL APD DRAINAGE CATHETER SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
EBERLE
FDA UDI
Eberle GmbH & Co. KG·04050052015923·Aggressive Full Radius Resector 3,5
OsteoMed
FDA UDI
OSTEOMED LLC·00845694046527·PrimaLIF LLIF PEEK Implant, 13mm X 26mm X 35mm,...
PTM SYSTEM
FDA 510(k)
FDA Class 2
·Dental
CELL-CHEX
FDA 510(k)
FDA Class 2
·Hematology
ADAPTA DR
FDA Adverse Event
Death
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NVZ·June 3, 2013
L9000 LIGHTSOURCE
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY SAN JOSE·Product code FCW·June 1, 2011
MDET TAXABLE
FDA Adverse Event
Malfunction
·STRYKER MEDICAL LONDON DBA CHG HOSPITAL BEDS·Product code FNL·October 9, 2015
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022