21 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PALTOP DENTAL IMPLANT - STERILE ACCESSORIES
FDA 510(k)
FDA Class 2
·Dental
ArgenIS
FDA UDI
ARGEN CORPORATION, THE·D818131451·MUA NC NP 2.5GH Ang17
APEX MODULE HIP SYSTEM BIOLOX DELTA FEMORAL HEAD
FDA 510(k)
FDA Class 2
·Orthopedic
XTRACXL PLUS EXCIMER LASER SYSTEM, MODEL AL7000
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 3, 2024
BALL HEADS: MECTACER BIOLOX DELTA CERAMIC 12/14 Ø 28 SIZE L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·December 14, 2021
MPACT DM DOUBLE MOBILITY HC LINER Ø 50/28
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·July 30, 2019
LINER: MPACT DM DOUBLE MOBILITY HC LINER 22.2/DMC
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·December 7, 2020
TELIGEN
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·October 1, 2014
SPRINT FIDELIS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·June 16, 2011
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·October 7, 2015
LINER: MPACT DM DM CONVERTER TIN COATED D/DMB
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·June 27, 2024
STEM: M-VIZION PROXIMAL BODY Ø20MM L 90MM STD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·April 9, 2024
REMSTAR AUTOA-FLEX
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·April 26, 2022
CUP: MPACT ACETABULAR SHELL Ø56 MULTI-HOLE
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·March 1, 2022
UNKNOWN XMTR
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code MDS·February 20, 2026
ACTIVA
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·December 30, 2019
BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·April 13, 2022
MPACT DOUBLE MOBILITY SHELLS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·February 21, 2024
Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012