8 results
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18ms
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Sources: EU EUDAMED, US FDA
DATASCOPE INTRA-AORTIC BALLOON WITH MODIFIED STAT GARD
FDA 510(k)
FDA Class 2
·Cardiovascular
Damon 3MX
FDA UDI
ORMCO CORPORATION·00889989002430·U1R DAMON3 MX 22 12/5/0
ND. YAG LASER RECTAL PATHOLOGY
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SATC-1114, SHOULDER ABUTMENT TRANSFER COPING
FDA 510(k)
FDA Class 2
·Dental
SCULPTRA (POLY-L-LACTIC ACID)
FDA Adverse Event
Injury
·SANOFIAVENTIS U.S. LLC·Product code LMH·December 28, 2010
CATH 6F INFINI ANG PIG 110C 6S
FDA Adverse Event
Malfunction
·CORDIS DE MEXICO·Product code DQO·February 5, 2013
3.5MM VARIABLE ANGLE LOCKING SCREW/SLF-TPNG/STRDRV/80MM
FDA Adverse Event
Injury
·DEPUY SYNTHES POWER TOOLS·Product code HWC·July 18, 2014
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