13 results · 20ms · Sources: EU EUDAMED, US FDA

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SBI SR MTP TOE IMPLANT

FDA 510(k)
FDA Class 2 ·Orthopedic

TRELLIS INFUSION SYSTEM (10CM INFUSION LENGTH); TRELLIS INFUSION SYSTEM (20CM INFUSION LENGTH)

FDA 510(k)
FDA Class 2 ·Cardiovascular

DW 276 #3

FDA 510(k)
FDA Class 2 ·Dental

WAVEWRITER ALPHA?

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·August 28, 2025

WAVEWRITER ALPHA 16

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 21, 2022

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·March 28, 2025

WAVEWRITER ALPHA

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·June 8, 2021

ATRICURE BIPOLAR SYSTEM

FDA Adverse Event
Injury ·ATRICURE, INC.·Product code GEI·July 28, 2010

PIPELINE EMBOLIZATION DEVICE

FDA Adverse Event
Injury ·EV3 NEUROVASCULAR·Product code OUT·April 23, 2013

THUNDERBEAT 5MM 35CM FRONT-ACTUATED GRIP

FDA Adverse Event
Malfunction ·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code GEI·August 21, 2014

SPIDER - SINGLE PORT SURGICAL DEVICE

FDA Adverse Event
Malfunction ·TRANSENTERIX INC.·Product code GCJ·April 13, 2011

SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2

FDA Enforcement
Class II ·Ongoing·Baxter Healthcare Corporation·January 28, 2026

Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012