14 results
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30ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TEMPORARY COLD.V AND SELF-CURE DENTINE
FDA 510(k)
FDA Class 2
·Dental
VANGUARD REPROCESSED ENDOSCOPIC INSTRUMENTS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
KSEA UNIMAT 12
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
LINEAR ST
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·September 2, 2021
MOTO PARTIAL KNEE 02.18.IF2.08.RM TIBIAL INSERT FIX S2 RM - 8MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code HSX·March 17, 2022
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 9, 2024
STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 1, SHORT NECK
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·March 15, 2022
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE CORPORATION·Product code KDJ·April 29, 2013
ENVE
FDA Adverse Event
Injury
·CAREFUSION 203, INC.·Product code CBK·April 27, 2011
LIFEPAK 20 DEFIBRILLATOR/MONITOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC·Product code LDD·July 23, 2008
INFUSOMAT SPACE
FDA Adverse Event
Malfunction
·B. BRAUN MELSUNGEN AG·Product code FRN·January 19, 2016
Z NAIL PF 14MM X 46CM UNIV Z NAIL GT 14MM X 46CM R Z NAIL GT 14MM X 46CM L Z NAIL TIBIA 14MM X 38CM UNIV Z NAIL TIBIA 14MM X 40CM UNIV Z NAIL TIBIA 14MM X 42CM UNIV Z NAIL TIBIA 14MM X 44CM UNIV
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·June 21, 2017
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