12 results · 24ms · Sources: EU EUDAMED, 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