12 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Surgical Face Mask
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Metzenbaum Scissors Curved 14cm
FDA UDI
CONCISE ENTERPRISES·G2021401825140·Metzenbaum scissors are a type of surgical scis...
NUVASIVE SPHERX II -MAS DEFORMITY SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
TENS/EMS COMBO, EMS, TENS
FDA 510(k)
FDA Class 2
·Neurology
INSYTE AUTOGUARD
FDA Adverse Event
Malfunction
·BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.·Product code FOZ·February 27, 2026
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·October 17, 2014
TIEMAN CATHETER 100% SILICONE 2WAY 5CC
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code KOD·July 8, 2011
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·June 11, 2013
COMPREHENSIVE SHOULDER SYSTEM NANO HUMERAL COMP
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HSD·September 26, 2023
COMPR NANO HMRL PPS 34MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWS·June 10, 2024
COMPREHENSIVE SHOULDER SYSTEM NANO NUMERAL COMPONENT 30 MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code HSD·March 21, 2024
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