13 results
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17ms
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Sources: EU EUDAMED, US FDA
SMILJANIC BONE REPOSITIONING FORCEPS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
XLX
FDA UDI
Nuvasive, Inc.·00887517944962·XLX ACR Expansion Driver, Std Inserter
SURGICAL ISOLATION GOWN
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BIOLOX DELTA CERAMIC FEMORAL HEAD
FDA 510(k)
FDA Class 2
·Orthopedic
HT70 PLUS VENTILATOR
FDA Adverse Event
Malfunction
·NEWPORT MEDICAL INSTRUMENTS, INC.·Product code CBK·April 16, 2014
SWEET PICOTIP
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·October 15, 2010
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·December 13, 2012
SINGLE FUNCTION ABC PENCIL, HAND CONTROL HANDPIECE
FDA Adverse Event
Malfunction
·CONMED ELECTROSURGERY·Product code HAM·September 11, 2015
BIOLOX HEAD HIP IMPLANT
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code JDI·April 25, 2019
ABC HANDPIECE LAPAROSCOPIC
FDA Adverse Event
Malfunction
·CONSOLIDATED MEDICAL EQUIPMENT·Product code HAM·February 19, 2019
UNKNOWN BIOLOX HEAD
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code LZO·February 13, 2018
CERASUL, HEAD, M/0, TAPER 12/14
FDA Adverse Event
Injury
·ZIMMER GMBH·Product code JDI·November 4, 2019
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 42, REF 106-22-42; b. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 44, REF 106-22-44; c. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 46, REF 106-22-46; d. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 48, REF 106-22-48; e. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 50, REF 106-22-50; f. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 52, REF 106-22-52; g. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 54, REF 106-22-54; h. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 48, REF 106-28-48; i. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 50, REF 106-28-50; j. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 52, REF 106-28-52; k. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 54, REF 106-28-54; l. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 56, REF 106-28-56; m. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 58, REF 106-28-58; n. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 28MM SZ 60, REF 106-28-60; o. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 52, REF 106-32-52; p. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 54, REF 106-32-54; q. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 56, REF 106-32-56; r. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 58, REF 106-32-58; s. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 32MM SZ 60, REF 106-32-60
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022