KRKClass II

Manometer, Blood-pressure, Venous

Cardiovascular · 21 CFR 870.1140

MDR events15All time

Recalls2All time

Registered firms1Currently listed

510(k) clearances9All time

Recent MDR events

15 adverse event reports on file

MANOMETER, BLOOD-PRESSURE, VENOUSAug 12, 2023
MalfunctionVortechMW5142720
MEDEX PRESSURE INFUSION CLEAR CUFFSep 9, 2022
MalfunctionSmiths Medical Asd, Inc.3012307300-2022-18328
MANOMETER BOTTOM ASSEMBLYMay 13, 2022
MalfunctionCarefusion, Inc1625685-2022-00052
MANOMETER TRAY STERILE 10/BX - 4330Sep 27, 2021
Injury1625685-2021-00064
MANOMETER TRAY STERILE 10/BX - 4330Aug 23, 2021
InjuryCarefusion, Inc1625685-2021-00053
PORTEX MANOMETERJun 22, 2020
MalfunctionSmiths Medical International, Ltd.3012307300-2020-06124
MANOMETER TRAY STERILE 10/BXSep 16, 2019
MalfunctionCarefusion, Inc1625685-2019-00110
SMITHS MEDICAL PORTEX HYPERINFLATION RESUSCITATION MANOMETERSAug 19, 2019
InjurySmiths Medical Asd, Inc.3012307300-2019-04040
CVP MANOMETERApr 16, 2003
InjuryMedex1526863-2003-00046
DOUBLE LUMEN SOFT CENTRAL VENOUS CATHETER TRAYJan 10, 2002
InjuryCook Incorporated1820334-2002-00006

Event type breakdown

Injury7

Malfunction7

Unspecified1

Most-reported manufacturers

Carefusion, Inc3 Smiths Medical Asd, Inc.2 Unspecified1 Abbott Laboratories1 Argon Medical Corp.1 Cook Incorporated1 Datascope Corporation1 Edwards Div., Baxter Healthcare Coorp.1

Recalls

2 recall events for this product code

Registered firms

1 firms currently registered for this product code

Icu Medical Healthcare Manufacturing S.a. De C.v.
APODACA Nuevo Leon, MX

510(k) clearances

9 clearances for this product code