19 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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ChemoCLAVE Cytotoxic Medication Preparation and Delivery System
FDA 510(k)
FDA Class 2
·General Hospital
MYSPINE MC VERTEBRA L04
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code PQC·July 6, 2018
PHOTONOVA FAMILY OF PULSED LIGHT SYSTEMS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PERMOBIL M300 / M400
FDA 510(k)
FDA Class 2
·Physical Medicine
REDUCTION CANNULATED PEDICLE SCREW 5X45
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·February 17, 2023
MYSPINE S01 DRILL BASED GUIDE
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code PQC·December 12, 2018
MYSPINE-MC DRILL GUIDE L03
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PQC·May 26, 2023
MYSPINE STOPPER SLEEVE 30 MM, DRILL2.7 - LUMBAR
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LXH·February 26, 2020
LIGASURE IMPACT
FDA Adverse Event
Malfunction
·COVIDIEN LLC (SHANGHAI)·Product code GEI·June 11, 2013
ACCU-CHEK MOBILE TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·July 23, 2011
MONOPOLAR CABLE 10 FEET
FDA Adverse Event
Malfunction
·INTEGRA YORK, PA INC.·Product code GEI·September 9, 2014
T2 - NAIL HANDLE
FDA Adverse Event
Malfunction
·STRYKER GMBH·Product code LXH·May 21, 2025
M.U.S.T. MIDLINE CORTICAL (MC) SCREW SYSTEM
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code NKB·July 16, 2025
MYSPINE UNILATERAL LEFT GUIDE S01
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code PQC·August 22, 2024
ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 5X40MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·January 10, 2024
M.U.S.T. MIDLINE CORTICAL (MC) SCREW SYSTEM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·December 13, 2024
MYSPINE MYSPINE MC DRILL BASED GUIDE L04
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PQC·February 14, 2020
Disposable Accessory Kit, 4-Arm (Box of 5) individually sealed in poly-Tyvek pouches / Rx Sterile / to used exclusively on the Intuitive Surgical Da Vinci Si Robotic system / Distributed by Intuitive Surgical Product Usage: Microtek Medical Equipment Drapes are intended to cover/wrap various surgical and/or nonsurgical instruments/equipment [e.g. robotic arms, microscopes, tables, x ray systems, light handles, etc]. They function as a physical barrier to prevent cross contamination between the instrument / equipment and medical staff and/or to allow the instrument/equipment to enter a hygienic area [e.g. sterile surgical field] in various clinical settings. They are typically made of flexible plastic and shaped to fit the type of instrument / equipment. They are a single use device [not to be reprocessed]
FDA Enforcement
Class II
·Terminated·Ecolab Inc·October 31, 2018
Medtronic MiniMed(TM) Quick-set(TM) (MMT-394, 394T, 399, 399T, 387, 387T, 398, 398T, 397, 397T, 386, 386T, 396, 396T)
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·November 29, 2017