14 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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FDA 510(k)
FDA Class 2
·Orthopedic
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526781702·LUMBAMED FACET 3 POINT SILVER III
ALADDIN-M
FDA UDI
VISIA IMAGING SRL·08034028770364·
ESR-Vacuum tubes
FDA UDI
STRECK, INC.·00844509000020·High altitude tri-sodium citrate blood collecti...
MHLX7EC TRANSDUCER
FDA 510(k)
FDA Class 2
·Radiology
DISPOSABLE ENDOSCOPIC CANNULA
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
VENTED HUMIDIFICATION CHAMBER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·June 30, 2025
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 28, 2025
FLO-GARD 6301 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FRN·November 24, 2008
PRECISION
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·September 9, 2011
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·July 22, 2013
ANATOMIC SHOULDER PROSTHESIS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code KWS·September 2, 2025
NSK
FDA Adverse Event
Injury
·NAKANISHI INC.·Product code KMW·March 7, 2024
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013