18 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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WiZARD 310/320 Series CPAP Mask
FDA 510(k)
FDA Class 2
·Anesthesiology
Darby Dental Supply, LLC
FDA UDI
DARBY DENTAL SUPPLY, LLC·00889813019221·GLOVES PF VINYL LRG HANDS ON DARBY
Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012
AMSCO V-PRO 1 LOW TEMPERATURE STERILIZATION SYSTEM; AMSCO V-PRO 1 PLUS LOW TEMPERATURE STERILIZATION SYSTEM
FDA 510(k)
FDA Class 2
·General Hospital
RUBICON 18 SUPPORT CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
EKOSONIC ENDOVASCULAR DEVICE, 135X12CM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KRA·February 3, 2023
EKOSONIC ENDOVASCULAR DEVICE, 135X12CM
FDA Adverse Event
Death
·BOSTON SCIENTIFIC CORPORATION·Product code KRA·February 3, 2023
EKOSONIC ENDOVASCULAR DEVICE, 106X12CM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KRA·March 1, 2023
RADIUS-7
FDA Adverse Event
Malfunction
·MASIMO CORPORATION·Product code DQA·July 2, 2015
EKOSONIC KIT 106CM 12CM TZ
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code KRA·December 14, 2021
MINICAP TRANSFER SET
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·June 21, 2013
OT VERIO PRO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 28, 2011
DA VINCI SURGICAL SYSTEM
FDA Adverse Event
Other
·INTUITIVE SURGICAL, INC.·Product code NAY·September 22, 2008
PATIENT SAFETY NET
FDA Adverse Event
Malfunction
·MASIMO CORPORATION·Product code MSX·March 31, 2016
PATIENT SAFETY NET
FDA Adverse Event
Malfunction
·MASIMO CORPORATION·Product code MSX·March 31, 2016
EKOSONIC ENDOVASCULAR DEVICE, 106X18CM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code KRA·May 3, 2022
EKOSONIC ENDOVASCULAR DEVICE, 106X18CM
FDA Adverse Event
Death
·BOSTON SCIENTIFIC CORPORATION·Product code KRA·February 3, 2023
Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Product Usage: Boston Scientific cardiac resynchronization therapy defibrillators (CRT-Ds) are indicated for patients with moderate to severe heart failure who remain symptomatic despite stable, optimal heart failure drug therapy and have left ventricular dysfunction and QRS duration > or equal to 120 ms. This family of pulse generators 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; -Cardiac Resynchronization Therapy (CRT), which treats heart failure by resynchronizing ventricular contractions through biventricular electrical stimulation; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 29, 2014