8 results
·
26ms
·
Sources: EU EUDAMED, US FDA
SOFSENS(TM) MODEL LMP-100 INTRAUTERINE PRES. TRANS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756555852·PPS PLASTICS TRAY
INTRAX FILM PROCESSOR
FDA 510(k)
FDA Class 2
·Radiology
Arthrex SwiveLock Suture Anchor
FDA 510(k)
FDA Class 2
·Orthopedic
INSORB
FDA Adverse Event
Malfunction
·INCISIVE SURGICAL INC.·Product code GAG·June 9, 2014
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·January 2, 2013
ARCHITECT C8000 SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT MANUFACTURING, INC.·Product code JJE·November 8, 2010
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