12 results
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20ms
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Sources: EU EUDAMED, US FDA
PUREVUE Quick Connect Cannula System Tray; PUREVUE Quick Connect Cannula System Lid
FDA 510(k)
FDA Class 2
·General Hospital
Unispace SA Cervical Cage
FDA 510(k)
FDA Class 2
·Orthopedic
Stainless Turbine
FDA 510(k)
FDA Class 1
·Dental
IMPLANT DRIVER EV (S) SHORT
FDA Adverse Event
Malfunction
·DENTSPLY IMPLANTS (A DIVISION OF DENTSPLY IH AB)·Product code NDP·April 20, 2026
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code EFB·October 14, 2022
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code EFB·October 14, 2022
COGNIS HE IS-1/DF-1/IS-1
FDA Adverse Event
Malfunction
·CARDIAC PACEMAKERS·Product code NIK·November 11, 2008
AFFINITY BED
FDA Adverse Event
Malfunction
·HILL-ROM INC.·Product code HDD·August 10, 2011
2520274-2013-04837
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·July 30, 2013
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code EFB·March 25, 2025
BARD Dynamic XT Deca Steerable, Product Number 201102, REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 29, 2014