11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Small Volume 0.2mL Syringe
FDA 510(k)
FDA Class 2
·General Hospital
Stainless Steel Archwire
FDA UDI
Ortho Arch Company Inc·D90925013816·.012 UPPER SS RIGHT FORM ARCHWIRES (50)
Aspen Laser Systems Therapy Laser System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MODIFICATION TO: RESTORATION MODULAR SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
IMPL TAPERED SCR-V MTX 6M M 5.7MM 11.5MM
FDA Adverse Event
Injury
·ZIMMER DENTAL·Product code DZE·April 19, 2024
CONTOUR PLUS
FDA Adverse Event
Malfunction
·ASCENSIA DIABETES CARE US INC·Product code NBW·August 10, 2018
MSS - HUMERAL REVERSE LINERS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code PHX·February 18, 2026
INTERMATE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code FRN·November 14, 2014
HAKIM PROGRAMMABLE VALVE
FDA Adverse Event
Injury
·CODMAN AND SHURTLEFF - MEDOS·Product code JXG·September 15, 2011
HEMODIALYSIS KIT: 2-L 15 FR X 23 CM
FDA Adverse Event
Malfunction
·ARROW INTL., INC.·Product code MSD·July 24, 2013
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