10 results
·
25ms
·
Sources: EU EUDAMED, US FDA
REAGENT SET TRIGLYCERIDES
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SPINEFRONTIER LUMBAR IBF SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Immunalysis Ethyl Alcohol Enzyme Assay
FDA 510(k)
FDA Class 2
·Clinical Toxicology
MENTOR SMOOTH ROUND MODERATE PROFILE
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FWM·September 17, 2018
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 15, 2014
ATTAIN ABILITY
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code OJX·October 31, 2012
BHR
FDA Adverse Event
Injury
·SMITH & NEPHEW ORTHOPAEDICS, LTD.·Product code NXT·August 23, 2010
REVOLVE ADVANCED ADIPOSE SYSTEM, for aspiration, harvesting, filtering, and transferring of autologous adipose tissue for aesthetic body contouring.
FDA Enforcement
Class II
·Terminated·LifeCell Corporation, A Wholly Owned Subsidiary of Allergan PLC·March 7, 2018
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022
Unify, Sterile EO, Model #/ Part #: CD3231-40/100029240, 100030104, 100041904; CD3231-40Q/100029281, 100030124, 100041905; CD3235-40/100029256, 100029293, 100029307, 100031111, 100037047, 100048897, 100070009; CD3235-40Q/100029257, 100029294, 100029308, 100031059, 100037048, 100070010; CD3281-40Q/100056770; CD3297-40/100056933
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018