13 results
·
27ms
·
Sources: EU EUDAMED, US FDA
HUMAN BLOOD IN ALSEVER'S
FDA 510(k)
FDA Class 1
·Microbiology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526780774·LEVAMED ACTIVE ANKLE SUP SLVR L V
AURADONICS
FDA UDI
AURADONICS INC.·00810033836657·LATEX ELASTICS 1/4" 6.5 oz. - NEON, 50000 ea., ...
Vilex Power Accessory
FDA UDI
VILEX IN TENNESSEE, INC.·00841731122230·KWire .045x9" (1.1x225mm)
SUNTANNING DEVICE (SEPAR. FROM K812225)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Cosmolock
FDA UDI
Kalitec Direct LLC·B07311K0112250·Tap, 7.50mm, Cannulated, Fixed Sleeve
MIS Ti-base abutment
FDA 510(k)
FDA Class 2
·Dental
ALTAPORE
FDA 510(k)
FDA Class 2
·Orthopedic
PINNACLE DM LINER 48_41
FDA Adverse Event
Injury
·DEPUY IRELAND - 9616671·Product code LPH·May 8, 2024
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·January 9, 2014
CARELINK
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code KRG·October 31, 2012
LIFEVEST WCD 4000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·August 11, 2010
CORAIL AMT HIGH OFFSET NECK SEGMENT (KHO), Pro. Code L20433 Product Usage: The affected CORAIL Neck Trials are surgical instruments used in CORAIL total and partial hip arthroplasty.
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·April 17, 2019