55 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SB Soft Hood - Straight type, SB Soft Hood - Undercut type
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LEONE SPA
FDA UDI
LEONE SPA·08033707001409·PALATAL MIM TUBES 1,1 mm
.
SNORE GUARD
FDA 510(k)
FDA Class 2
·Dental
SOMNOMED BFLEX
FDA 510(k)
FDA Class 2
·Dental
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·May 30, 2013
ALTRUA
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·July 23, 2011
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 19, 2008
Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device Ethicon LLC Guaynabo, Puerto Rico 00969. Intended for general soft tissue approximation where use of an absorbable suture is appropriate.
FDA Enforcement
Class II
·Terminated·Ethicon, Inc.·December 18, 2013
RADIFOCUS GLIDEWIRE ADVANTAGE
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DQX·May 1, 2020
GLIDEWIRE ADVANTAGE
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQX·July 9, 2025
RADIFOCUS GLIDEWIRE ADVANTAGE
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DQX·June 23, 2022
N-COMPASS NITINOL STONE EXTRACTOR
FDA Adverse Event
Malfunction
·COOK INC·Product code LQR·April 1, 2022
N-COMPASS NITINOL STONE EXTRACTOR
FDA Adverse Event
Malfunction
·COOK INC·Product code LQR·April 1, 2022
RADIFOCUS GLIDEWIRE ADVANTAGE
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQX·February 3, 2025
N-COMPASS NITINOL STONE EXTRACTOR
FDA Adverse Event
Malfunction
·COOK INC·Product code LQR·April 1, 2022
RADIFOCUS GUIDEWIRE ADVANTAGE
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQX·July 12, 2024
RADIFOCUS GLIDEWIRE ADVANTAGE
FDA Adverse Event
Malfunction
·TERUMO MEDICAL CORPORATION·Product code DQX·August 30, 2023
RADIFOCUS GLIDEWIRE ADVANTAGE
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQX·August 7, 2020
RADIFOCUS GLIDEWIRE ADVANTAGE
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DQX·October 16, 2020
RADIFOCUS GLIDEWIRE ADVANTAGE
FDA Adverse Event
Malfunction
·TERUMO CORPORATION, ASHITAKA·Product code DQX·December 3, 2020