221 results · 61ms · Sources: EU EUDAMED, US FDA

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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