21 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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RetiCapture
FDA 510(k)
FDA Class 2
·Ophthalmic
Accent 800 TouchGuide 4 Location
FDA UDI
PRENTKE ROMICH COMPANY·00858526006460·TouchGuides are made from a thin, clear polycar...
MYSPINE MC VERTEBRA L04
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code PQC·July 6, 2018
CAPIOX CIRCUIT CONNECTORS
FDA 510(k)
FDA Class 2
·Cardiovascular
ENA TEMP AND ENAMEL PLUS TEMP (TWO DIFFERENT PROPRIETARY NAMES FOR THE SAME PRODUCT)
FDA 510(k)
FDA Class 2
·Dental
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
BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·December 6, 2018
MYSPINE-MC DRILL GUIDE L03
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PQC·May 26, 2023
GEM MICROVASCULAR ANASTOMOTIC COUPLER
FDA Adverse Event
Malfunction
·SYNOVIS SURGICAL INNOVATIONS·Product code MVR·December 28, 2016
MYSPINE STOPPER SLEEVE 30 MM, DRILL2.7 - LUMBAR
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LXH·February 26, 2020
PLUM XLM W/DATAPORT
FDA Adverse Event
Malfunction
·HOSPIRA COSTA RICA LTD.·Product code FRN·October 10, 2014
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FPA·July 23, 2011
ADVANTA BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·June 11, 2013
smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 2.6mm O.D. (7.8Fr) x 1.6mm I.D., REF 21-4155-24
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD, Inc.·March 26, 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