20 results · 21ms · Sources: EU EUDAMED, US FDA

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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