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

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AMCO REPLACEMENT BATTERY FOR POWERHEART AED, NON-RECHARGEABLE, MODEL 2L561; G3, NON-RECHARGABLE, MODEL 7L561

FDA 510(k)
FDA Class 3 ·Cardiovascular

VASCUPUNCTURE ACCESS WIRE

FDA 510(k)
FDA Class 2 ·Cardiovascular

EO GAS STERILIZATION PROCESS INDICATOR TAPES, MODEL CI 124

FDA 510(k)
FDA Class 2 ·General Hospital

WAVEWRITER ALPHA?

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·December 31, 2025

VANGUARD BEARING COMPONENT

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JWH·August 20, 2018

VANGUARD TIBIAL TRAY COMPONENT

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JWH·August 20, 2018

VANGUARD FEMORAL COMPONENT

FDA Adverse Event
Injury ·ZIMMER BIOMET, INC.·Product code JWH·August 20, 2018

LINOX SD 65/18

FDA Adverse Event
Malfunction ·BIOTRONIK SE & CO. KG·Product code NVY·April 29, 2013

LIGASURE ATLAS HANDSWITCHING 37CM

FDA Adverse Event
Malfunction ·COVIDIEN LLC, (SHANGHAI)·Product code GEI·April 29, 2011

OLYMPUS

FDA Adverse Event
Malfunction ·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code FDF·July 25, 2008

On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

FDA Enforcement
Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

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