14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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NB3D BONE VOID FILLER
FDA 510(k)
FDA Class 2
·Orthopedic
MEGA PLUS SPINE SYSTEM
FDA UDI
BK MEDITECH CO.,LTD.·08809665580283·Rod(CoCr), Ø6.0 x 500mm
Forestanit®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR21320501·Forestanit wire round spring-hard laboratory co...
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B16741320500·
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B1674132050060·
PERIVAC KIT
FDA 510(k)
FDA Class 2
·Cardiovascular
Q-SWITCHED ND:YAG LASER SYSTEM, MODEL GLOBALCURE-SC6
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
FDA Adverse Event
Injury
·BIOSENSE WEBSTER INC·Product code LPB·June 6, 2018
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·May 29, 2013
ASKU
FDA Adverse Event
Malfunction
·MEDTRONIC MILACA INC.·Product code DTE·June 16, 2011
ALUMINA V40-FEMORAL HEAD 36MM, +0MM NK
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS CORK·Product code LZO·August 21, 2008
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
e.cam line of gamma camera systems Used to detect or image the distribution of radionuclides in the body or organ.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·October 29, 2014
Copeland HA Resurfacing Head, MB/HA EAS Head; Item Nos. 11-114641 11-114642 11-114643 11-114644 11-114644S 11-114645 11-114646 11-114647 11-114648 11-114661 11-114662 11-114663 11-114664 11-114664S 11-114665 11-114666 11-114667 11-114668 11-114632 11-114633 Product Usage: Partial Shoulder Replacement.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·December 4, 2019