14 results · 30ms · Sources: EU EUDAMED, US FDA

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BD RECYKLEEN SHARPS COLLECTORS

FDA 510(k)
FDA Class 2 ·General Hospital

JOSTRA ARTERIAL PERFUSION CANNULAE

FDA 510(k)
FDA Class 2 ·Cardiovascular

VACUETTE QUICKSHIELD WITH SNAPPY TUDE HOLDER

FDA 510(k)
FDA Class 2 ·General Hospital

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·May 14, 2013

TOTALCARE SPO2RT

FDA Adverse Event
Malfunction ·HILL-ROM, INC.·Product code FNL·April 29, 2011

VERSACARE

FDA Adverse Event
Malfunction ·HILL-ROM RITTER·Product code FNL·August 15, 2008

BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA S.R.L.·Product code DTN·February 22, 2017

BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA·Product code DTN·March 24, 2016

BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA·Product code DTN·March 24, 2016

BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG

FDA Adverse Event
Malfunction ·SORIN GROUP ITALIA·Product code DTN·July 25, 2018

Z NAIL PF 14MM X 46CM UNIV Z NAIL GT 14MM X 46CM R Z NAIL GT 14MM X 46CM L Z NAIL TIBIA 14MM X 38CM UNIV Z NAIL TIBIA 14MM X 40CM UNIV Z NAIL TIBIA 14MM X 42CM UNIV Z NAIL TIBIA 14MM X 44CM UNIV

FDA Enforcement
Class II ·Terminated·Zimmer Biomet, Inc.·June 21, 2017

Ventec Life Systems VOCSN Multi-Function Ventilator Model/Version/Catalog Number: V+O+C+S+N+Pro/English/PRT-00490-001; V+O+C+S+N+Pro/Japan/PRT-00490-100; V+C+Pro/English/PRT-00900-001; V+C+Pro/Japan/PRT-00900-100; V+C/English/PRT-01098-000; V+O+C+S+N/English/PRT-01100-000; V+O+C+S+N/English/PRT-01100-001;

FDA Enforcement
Class II ·Ongoing·Ventec Life Systems, Inc.·June 30, 2021

Veradius Unity with Software Release 2.1- Amobile, diagnostic X-ray imaging and viewing system. . Model Number: 718132

FDA Enforcement
Class II ·Ongoing·Philips North America Llc·December 15, 2021

INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021