7 results
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25ms
·
Sources: EU EUDAMED, US FDA
TRANSTHORACIC/TRANSABDOMINAL-TRAY
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ARI COLD SPRAY
FDA 510(k)
FDA Unclassified
·Unknown
Luminopia
FDA 510(k)
FDA Class 2
·Ophthalmic
RESERVOIR 3ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·May 27, 2014
ACRYSOF
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD. / HUNTINGTON·Product code HQL·November 12, 2012
UNKNOWN DEPUY PATELLA
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code HTG·September 8, 2010
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. 0 DEG ACUMATCH CONSTRAINED LINER SZ E 28MM ID, REF 144-28-05; b. 0 DEG ACUMATCH CONSTRAINED LINER SZ F 28MM ID, REF 144-28-06; c. 0 DEG ACUMATCH CONSTRAINED LINER SZ G 28MM ID, REF 144-28-07; d. 0 DEG ACUMATCH CONSTRAINED LINER SZ H 28MM ID, REF 144-28-08; e. 0 DEG ACUMATCH CONSTRAINED LINER SZ J 28MM ID, REF 144-28-09; f. 0 DEG ACUMATCH CONSTRAINED LINER SZ K 28MM ID, REF 144-28-10; g. 0 DEG MCS CONSTRAINED LINER 50-52 MM, 28 MM ID, REF 146-28-04; h. 0 DEG MCS CONSTRAINED LINER 54-58 MM, 28 MM ID, REF 146-28-05; i. 0 DEG MCS CONSTRAINED LINER 60-64 MM, 32MM ID, REF 146-32-06; j. O DEG ACUMATCH CONSTRAINED LINER SZ E 32MM ID, REF 144-32-05; k. O DEG ACUMATCH CONSTRAINED LINER SZ F 32MM ID, REF 144-32-06; l. O DEG ACUMATCH CONSTRAINED LINER SZ G 32MM ID, REF 144-32-07; m. O DEG ACUMATCH CONSTRAINED LINER SZ H 32MM ID, REF 144-32-08; n. O DEG ACUMATCH CONSTRAINED LINER SZ J 32MM ID, REF 144-32-09; o. O DEG ACUMATCH CONSTRAINED LINER SZ K 32MM ID, REF 144-32-10;
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022