13 results · 23ms · Sources: EU EUDAMED, US FDA

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ELI 350 ELECTROCARDIOGRAPH

FDA 510(k)
FDA Class 2 ·Cardiovascular

RTE SNAPCONE

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code FHW·July 11, 2023

HARDYDISK NETILMICIN, 30MCG

FDA 510(k)
FDA Class 2 ·Microbiology

EASY MOVING MOBILE X-RAY UNIT (MODEL SM-HF)

FDA 510(k)
FDA Class 2 ·Radiology

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·February 17, 2026

REAR TIP EXTENDER

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code N/A·December 30, 2025

RTE SNAPCONE

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code FHW·February 17, 2021

TIP COVER ACCESSORY

FDA Adverse Event
Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·May 3, 2013

LUMAX 340 VR-T

FDA Adverse Event
Injury ·BIOTRONIK GMBH AND CO·Product code LWS·August 1, 2008

EON C 16-CHANNEL IPG

FDA Adverse Event
Injury ·ST JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 10, 2011

TFNA FEM NAIL Ø11 LE 130° L300 TIMO15

FDA Adverse Event
Malfunction ·SYNTHES MONUMENT·Product code HSB·January 9, 2017

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

Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024