221 results
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61ms
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Sources: EU EUDAMED, US FDA
POM Procedural Oxygen Masks, Endoscopic, Conscious Sedation, Bronchoscopy Mask, as follows: (1) POM Medical, LLC, REF 1001-MM, High/Med Concentrations, Distributed by POM Medical, LLC, Moorpark, CA; (2) curaplex, REF 301-0318LT, Medium Concentration, Distributed by Sarnova HC, LLC's family of companies: Bound Tree Medical, LLC, Cardio Partners, Inc., Emergency Medical Products, Inc. & Tri-anim Health Services, Inc., Dublin, OH; and (3) POM Medical, LLC REF 1001-MF, High/Med Concentrations, Distributed by POM Medical, LLC, Moorpark, CA. All are packaged 1 mask/plastic pouch, 30 masks/case.
FDA Enforcement
Class II
·Terminated·POM Medical LLC·November 6, 2019
QUICK TAP PARACENTESIS TRAY
FDA Adverse Event
TRI-MED SPECIALTIES, INC.·Product code GAA·February 9, 1995
UNICEL DXC 800 SYNCHRON SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·December 16, 2011
VIBRANT SOUNDBRIDGE
FDA Adverse Event
Injury
·VIBRANT MED-EL HEARING TECHNOLOGY GMBH·Product code MPV·November 25, 2011
POM Procedural Oxygen Masks, Endoscopic, Conscious Sedation, Bronchoscopy Mask, as follows: (1) POM Medical, LLC, REF 1001-MM, High/Med Concentrations, Distributed by POM Medical, LLC, Moorpark, CA; (2) curaplex, REF 301-0318LT, Medium Concentration, Distributed by Sarnova HC, LLC's family of companies: Bound Tree Medical, LLC, Cardio Partners, Inc., Emergency Medical Products, Inc. & Tri-anim Health Services, Inc., Dublin, OH; and (3) POM Medical, LLC REF 1001-MF, High/Med Concentrations, Distributed by POM Medical, LLC, Moorpark, CA. All are packaged 1 mask/plastic pouch, 30 masks/case.
FDA Recall
Terminated
·POM Medical LLC·Product code BYG·July 11, 2018
CATGUT CHROMIC 2/0 (3.5) 100M
FDA Adverse Event
Malfunction
·B.BRAUN SURGICAL SA·Product code GAL·June 22, 2017
INAMED AESTHETICS BREAST IMPLANT
FDA Adverse Event
Injury
·INAMED/ ALLERGAN·Product code FTR·January 26, 2023
DYNA MED INC.
FDA Adverse Event
Malfunction
·DYNA MED INC.·Product code HST·February 22, 2007
CORFLO NG/NI FEED TUBE WITH STYLET, ENFIT CONNECTOR
FDA Adverse Event
Malfunction
·AVANOS MEDICAL INC.·Product code KNT·February 26, 2026
TRI-STAPLE 2.0
FDA Adverse Event
Malfunction
·COVIDIEN LP LLC NORTH HAVEN·Product code GDW·September 11, 2024
SABINA II
FDA Adverse Event
Death
·LIKO AB·Product code FSA·January 20, 2006
INFUSOMAT®
FDA Adverse Event
Injury
·B.BRAUN MELSUNGEN AG·Product code FRN·February 27, 2024
SMARTPHONE IOS APP: PUMP CONNECT
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code PKU·July 25, 2023
PRESTIGE ATRA GRASPERSGL-ACT5MM 36CM
FDA Adverse Event
Malfunction
·SMITH & NEPHEW ENDOSCOPY·Product code GCJ·June 12, 2008
FISCHER CONE BIOP EX MED
FDA Adverse Event
Malfunction
·COOPERSURGICAL, INC.·Product code HGI·May 26, 2020
CORFLO NG/NI FEED TUBE WITH STYLET, ENFIT CONNECTOR
FDA Adverse Event
Malfunction
·AVANOS MEDICAL INC.·Product code KNT·May 27, 2026
UNKNOWN ENTERAL FEEDING TUBE
FDA Adverse Event
Injury
·AVANOS MEDICAL INC.·Product code KNT·August 12, 2020
TEMPO
FDA Adverse Event
Injury
·ARJO MED AB LTD.·Product code FSA·March 17, 2011
CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - SMALL
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER INC·Product code DYB·September 2, 2025
DELTAXSFT10 2.5MM X 4CM
FDA Adverse Event
Malfunction
·REFER TO SECTION H10·Product code KRD·February 20, 2018