20 results
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21ms
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Sources: EU EUDAMED, US FDA
EXTENSION SET/I.V. SET
FDA 510(k)
FDA Class 2
·General Hospital
X-CORE
FDA UDI
Nuvasive, Inc.·00887517266866·X-CORE Mini Core, Ø12mm 25-39mm
G-aenial™
FDA UDI
Gc America Inc.·15400556015190·G-aenial A'CHORD Syringe AE
Interface, TCA ImmunoCap 1000
FDA UDI
Thermo Fisher Scientific Oy·06438153000655·Interface, TCA ImmunoCap 1000 is a module of TC...
One Coat 7 Universal
FDA 510(k)
FDA Class 2
·Dental
PROACT WITH GEL OR PROACT 1
FDA 510(k)
FDA Class 2
·Cardiovascular
HEARTSTART SLA BATTERY
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code DQA·May 13, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·February 9, 2013
UNO
FDA Adverse Event
Malfunction
·LIKO AB·Product code FSA·January 4, 2011
GELWEAVE STRAIGHT GRAFT
FDA Adverse Event
Injury
·VASCUTEK LTD.·Product code DSY·August 10, 2012
GELWEAVE STRAIGHT GRAFT
FDA Adverse Event
Injury
·VASCUTEK LTD.·Product code DSY·August 10, 2012
GELWEAVE STRAIGHT GRAFT
FDA Adverse Event
Injury
·VASCUTEK LTD.·Product code DSY·August 10, 2012
GELWEAVE STRAIGHT GRAFT
FDA Adverse Event
Injury
·VASCUTEK LTD.·Product code DSY·August 10, 2012
GELWEAVE STRAIGHT GRAFT
FDA Adverse Event
Injury
·VASCUTEK LTD.·Product code DXC·August 10, 2012
GELWEAVE STRAIGHT GRAFT
FDA Adverse Event
Injury
·VASCUTEK LTD.·Product code DXC·August 10, 2012
GELWEAVE STRAIGHT GRAFT
FDA Adverse Event
Injury
·VASCUTEK LTD.·Product code DSY·August 10, 2012
GELWEAVE STRAIGHT GRAFT
FDA Adverse Event
Injury
·VASCUTEK LTD.·Product code DSY·August 10, 2012
GELWEAVE STRAIGHT GRAFT
FDA Adverse Event
Injury
·VASCUTEK LTD.·Product code DSY·August 10, 2012
Bivona Aire-Cuf Endotracheal Tube
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD Inc.·November 3, 2021
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH GXL 0 DEGREE LINER 28MM SZ E, REF 130-28-25 b. ACUMATCH GXL 0 DEGREE LINER 28MM SZ F, REF 130-28-26 c. ACUMATCH GXL 0 DEGREE LINER 28MM SZ G, REF 130-28-27 d. ACUMATCH GXL 0 DEGREE LINER 28MM SZ H, REF 130-28-28 e. ACUMATCH GXL 0 DEGREE LINER 28MM SZ J, REF 130-28-29 f. ACUMATCH GXL 0 DEGREE LINER 32MM SZ G, REF 130-32-27 g. ACUMATCH GXL 0 DEGREE LINER 32MM SZ H, REF 130-32-28 f. ACUMATCH GXL 0 DEGREE LINER 32MM SZ J, REF 130-32-29 g. ACUMATCH GXL 0 DEGREE LINER 36MM SZ H, REF 130-36-28 h. ACUMATCH GXL 0 DEGREE LINER 36MM SZ J, REF 130-36-29 i. ACUMATCH GXL 0 DEGREE LINER 36MM SZ K, REF 130-36-30 j. ACUMATCH GXL 15 DEG +5 LAT LINER 28MM SZ E, REF 138-28-25 k. ACUMATCH GXL 15 DEG +5 LAT LINER 28MM SZ F, REF 138-28-26 l. ACUMATCH GXL 15 DEG +5 LAT LINER 28MM SZ G, REF 138-28-27 m. ACUMATCH GXL 15 DEG +5 LAT LINER 28MM SZ H, REF 138-28-28 n. ACUMATCH GXL 15 DEG +5 LAT LINER 28MM SZ J, REF 138-28-29 o. ACUMATCH GXL 15 DEG +5 LAT LINER 36MM SZ H, REF 138-36-28 p. ACUMATCH GXL 15 DEG +5 LAT LINER 36MM SZ J, REF 138-36-29 q. ACUMATCH GXL 15 DEG +5 LAT LINER 36MM SZ K, REF 138-36-30 r. ACUMATCH GXL 15 DEG +5 LAT LINER SZG 38MM, REF 138-36-27 s. ACUMATCH GXL 15DEG LINER 28MM SZ D, REF 132-28-24 t. ACUMATCH GXL 15DEG LINER 28MM SZ E, REF 132-28-25 u. ACUMATCH GXL 15DEG LINER 28MM SZ F, REF 132-28-26 v. ACUMATCH GXL 15DEG LINER 28MM SZ G, REF 132-28-27 w. ACUMATCH GXL 15DEG LINER 28MM SZ H, REF 132-28-28 x. ACUMATCH GXL 15DEG LINER 28MM SZ J, REF 132-28-29 y. ACUMATCH GXL 15DEG LINER 28MM SZ K, REF 132-28-30 z. ACUMATCH GXL 15DEG LINER 32MM SZ G, REF 132-32-27 aa. ACUMATCH GXL 15DEG LINER 32MM SZ H, REF 132-32-28 bb. ACUMATCH GXL 15DEG LINER 32MM SZ J, REF 132-32-29 cc. ACUMATCH GXL 15DEG LINER 32MM SZ K, REF 132-32-30 dd.ACUMATCH GXL 15DEG LINER 36MM SZ H, REF 132-36-28 ee. ACUMATCH GXL 15DEG LINER 36MM SZ J, REF 132-36-29 ff. ACUMATCH GXL 15DEG LINER 36MM SZ K, REF 132-36-30 gg. ACUMATCH GXL EXT COV LINER 28MM SZ E, REF 134-28-25 hh. ACUMATCH GXL EXT COV LINER 28MM SZ F, REF 134-28-26 ii. ACUMATCH GXL EXT COV LINER 28MM SZ G, REF 134-28-27 jj. ACUMATCH GXL EXT COV LINER 28MM SZ H, REF 134-28-28 kk. ACUMATCH GXL EXT COV LINER 28MM SZ J, REF 134-28-29 ll. ACUMATCH GXL EXT COV LINER 28MM SZ K, REF 134-28-30 mm. MCS GXL LINER 5/15 DEG 4448X28, REF 104-28-43 nn. MCS GXL LINER 5/15 DEG 5052X28, REF 104-28-44 oo. MCS GXL LINER 5/15 DEG 5458X28, REF 104-28-45 pp. MCS GXL LINER 5/15 DEG 5458X32, REF 104-32-45 qq. MCS GXL LINER 5/15 DEG 6064X32, REF 104-32-46 rr. MCS GXL LINER 5/15 DEG 6064X36, REF 104-36-46 ss. MCS GXL LINER 5/15 DEG 6670X36, REF 104-36-47
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022