7 results
·
26ms
·
Sources: EU EUDAMED, US FDA
ALANINE AMINOTRANSFERASE REAGENT SYSTEM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DIEGO ELITE DRILL
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
C2000 AUTOMATED MANIFOLD KIT
FDA 510(k)
FDA Class 2
·Cardiovascular
PLUM XL PLS MIC/MAC
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·May 19, 2014
PULSE-GENERATOR, PACEMAKER, IMPLANTABLE
FDA Adverse Event
Malfunction
·RICE CREEK MFG·Product code DXY·February 9, 2013
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·January 7, 2011
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