19 results
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27ms
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Sources: EU EUDAMED, US FDA
DYNA-LOK CLASSIC SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526827936·ACHIMED ACHILLES SUPP BLACK V
Midway Select
FDA UDI
MIDWAY DENTAL SUPPLY, LLC·10843717101229·Burs FGSL 2, Pkg/5
N/A
FDA UDI
BIOMET MICROFIXATION, INC·00841036019402·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450258156·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450237908·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450265215·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450412947·
ELECSYS ANTI-THYROID PEROXIDASE ANTIBODY TEST SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
PHILIPS INTEGRIS ALLURA 9 WITH FD OPTION
FDA 510(k)
FDA Class 2
·Radiology
FREESTYLE
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC.·Product code LFR·May 25, 2007
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVAMEX·Product code IOR·March 25, 2013
COAGUCHEK® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·March 16, 2011
HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)
FDA Adverse Event
Injury
·THORATEC CORPORATION·Product code DSQ·July 22, 2020
ULTRA 2 CUTTING BALLOON
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code LOX·August 4, 2010
OLYMPUS CYSTOSCOPE
FDA Adverse Event
Injury
·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code NWB·April 28, 2021
Abbott i-STAT PT/INR cartridges Abbott Point of Care Inc., Princeton, NJ 08540 The i-Stat PT a prothrombin time test is useful for monitoring patients receiving oral anticoagulation therapy such as Coumadin or Warfarin. The cartridge is to be used with the i-Stat 1 Analyzer and as part of the i-Stat System, the PT/INR test is to be used by trained health care professionals in accordance with a facility's policies and procedures.
FDA Enforcement
Class II
·Terminated·Abbott Point Of Care Inc.·December 11, 2013
Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
FDA Enforcement
Class II
·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024
Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quadra Assura MP, Model No. CD3269-40, CD3269-40Q, CD3369-40C. Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing. Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing
FDA Enforcement
Class I
·Terminated·St Jude Medical Inc.·November 2, 2016