16 results
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65ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SternaLock® 360 Sternal Closure System
FDA 510(k)
FDA Class 2
·Orthopedic
AGC Tradition Knee System
FDA UDI
Biomet Orthopedics, LLC·00880304008243·
HHM
FDA UDI
Oticon A/S·05707131282798·H110V2, BTE 13 WL 100 STG HHM
GEN4 INTERACTIVE
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828190091·GEN4 INTERACTIVE
VARIANT
FDA UDI
CAMBER SPINE TECHNOLOGIES, LLC·B030SPO1510190·Threaded Fixation Pin, ø3mm x 190mm
SURGIMAP (TM) SPINE
FDA 510(k)
FDA Class 2
·Radiology
SAFETY NEEDLE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
PRODIGY AUTOCODE
FDA Adverse Event
Injury
·OK BIOTECH CO., LTD.·Product code NBW·December 19, 2017
FENESTRATED BIPOLAR FORCEPS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·June 6, 2013
COGNIS
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·July 6, 2011
PRECISION XTRA /OPTIUM
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC. USA·Product code NBW·August 29, 2008
INVERS/REVERS SCR SYST 4.5-36
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code PHX·September 2, 2025
ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM BASEPLATE
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWT·April 16, 2025
PRODIGY AUTOCODE
FDA Adverse Event
Injury
·OK BIOTECH CO., LTD.·Product code NBW·September 29, 2016
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACH TUBE , Product Code/List Number/Item Code 60N030; b) NEONATAL TRACH TUBE , Product Code/List Number/Item Code 60N035; c) NEONATAL TRACH TUBE , Product Code/List Number/Item Code 60N040;
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024
Medical Linear Accelerator
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·September 14, 2016