13 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VIZTEK DR, MODELS: DR1000, DR3000, DR4000
FDA 510(k)
FDA Class 2
·Radiology
WAVEWRITER ALPHA?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·June 13, 2025
CENTURION 2000 CENTRAL STATION ARRHYTHMIA PATIENT MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
POWDER FREE ELASTIC VINYL EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
FEMORAL MODULAR HEAD
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code LZO·January 30, 2024
BD LUER-LOK¿ TIP SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·October 28, 2021
ICON 25 HCG (COMBO CASSETTE)
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code JHI·April 23, 2013
INTERPULSE HANDPIECE WITH HIGH FLOW TIP
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS PUERTO RICO·Product code FQH·April 27, 2011
IPG NEURO
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code GZB·July 25, 2008
Stat Profile Critical Care Xpress (CCX) Analyzer Catalog Number: 35942
FDA Recall
Terminated
·Nova Biomedical Corporation·Product code CHL·March 30, 2004
BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
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