8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
BARNES-HIND SPECTACLE LENS CLEANER
FDA 510(k)
FDA Class 1
·Ophthalmic
Stowe Pedicle Screw System
FDA 510(k)
FDA Class 2
·Orthopedic
LORENZ LACTOSORB VOCAL MEDIALIZATION IMPLANT
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 15, 2014
SPRINT QUATTRO
FDA Adverse Event
Injury
·MPRI·Product code LWS·October 31, 2012
3005075853-2010-04779
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·August 23, 2010
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