12 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Smith & Nephew SURESHOT Distal Targeting System V4.0 Targeter
FDA 510(k)
FDA Class 2
·Neurology
Orthopedic Instruments
FDA UDI
GM DOS REIS INDUSTRIA E COMERCIO LTDA·07899258695310·
Femoral Cutting Block
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215062989·
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·September 28, 2020
RAPIDPOINT 405 NEONATAL BILIRUBIN
FDA 510(k)
FDA Class 1
·Clinical Chemistry
VITAL COUGH
FDA 510(k)
FDA Class 2
·Anesthesiology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 11, 2025
SUPER TURBOVAC 90 ICW
FDA Adverse Event
Malfunction
·ARTHROCARE CORPORATION·Product code GEI·October 15, 2014
UNKNOWN DEPUY BONE CEMENT
FDA Adverse Event
Injury
·9610921 DEPUY CMW·Product code LOD·June 20, 2013
AXIUM 3-D DETACHABLE COIL
FDA Adverse Event
Malfunction
·EV3 NEUROVASCULAR·Product code HCG·July 27, 2011
Instrument Arm Drape (Box of 20) individually sealed in poly-Tyvek pouches / Rx Sterile / to used exclusively on the Intuitive Surgical Da Vinci Si Robotic system Distribute 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
Disposable Accessory Kit, 3-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