ClearanceBrief
Panels › Cardiovascular › Product code DRS · Class 2

Transducer, Blood-Pressure, Extravascular

Regulation 870.2850

1510(k)s in 12 months (149 all time)
2recalls in 12 months (236 all time)
226recalls that name a 510(k)
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Top companies in DRS

Company510(k)sRecalls
ICU Medical, Inc.0198
Smiths Medical Asd, Inc.218
Edwards Lifesciences, LLC37
Argon Medical Devices, Inc09
Medex, Inc.70
Sorensen Research70
Gould, Inc.60
Transamerica Delaval, Inc.60
Hewlett-Packard Co.50
Bentley Laboratories, Inc.40
DateFirm and productCodeLinked 510(k)
Nov 15, 2016ICU Medical, Inc.
MONITORING KIT W/30 ML FLUSH DEVICE FOR EGLESTON HOSP., Item No. 46094-50 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
QUAD KIT WITH THREE TRANSPAC AND 03ML FLUSH DEVICES FOR ST. FRANCIS HOSP., Item No. 46094-47 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that in
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
MONITORING KIT WITH 03ML FLUSH DEVICE FOR NYU MED CTR, Item No. 46094-37 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a c
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
TRIFURCATED KIT W/03ML FLUSH DEVICE FOR DUKE UNIVERSITY, Item No. 46094-21 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
BIFURCATED KIT W/03ML FLUSH DEVICE FOR DUKE UNIVERSITY, Item No. 46094-20 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
OPEN HEART KIT W/03ML FLUSH DEVICE FOR CUMBERLAND COUNTY HOSP., Item No. 46094-08 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces be
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
PEDIATRIC CVL MONITORING KIT W/03ML FLUSH DEVICE FOR YALE NEW HAVEN HOSP., Item No. 46094-06 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that in
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
CATH LAB KIT FOR SALINA REGIONAL, Item No. 46092-34 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
TRIPLE PRESSURE KIT W/03ML FLUSH DEVICE FOR UNIV. OF IOWA, Item No. 46091-56 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
PERFUSION KIT FOR UNIV. OF IOWA, Item No. 46091-51 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure m
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
ARTERIAL PRESSURE KIT W/03ML FLUSH DEVICE FOR LEBONHEUR CHILDRENS HOSP., Item No. 46091-31 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that inte
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
MONITORING KIT WITH 03ML FLUSH DEVICE FOR CONCORD HOSP., Item No. 46091-13 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
CVP ARTERIAL LINE KIT WITH 03ML FLUSH DEVICE FOR KANSAS HEART HOSP, Item No. 46091-04 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interface
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
Cath Lab Kit W/30ML Flush Device for Monongalia General Hosp, Item No. 46090-62 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces betw
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
CATH LAB KIT WITH 03ML FLUSH DEVICE FOR MEMORIAL HEALTHCARE, Item No. 46090-07 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces betwe
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
CATH LAB KIT FOR GENESIS HEALTH CARE, Item No. 46089-74 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and press
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
TRIFURCATED DISPOSABLE TRANSDUCER KIT W/03ML FLUSH DEVICE FOR JOHNS HOPKINS/BAYVIEW, Item No. 46088-74 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transduc
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
TRIPLE MK W/03ML FLUSH DEVICE FOR UNIV OF PENN. HEALTH SYSTEMS, Item No. 46088-08 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces be
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
CATH LAB KIT WITH 03ML FLUSH DEVICE FOR CARLE CLINIC, Item No. 46087-37 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a ca
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
ADD-ON DISP. TRANSDUCER W/03ML FLUSH DEVICE FOR JOHNS HOPKINS HOSP., Item No. 46086-21 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfac
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
TRIFURCATED DISP. TRANSDUCER W/03ML FLUSH DEVICE FOR JOHNS HOPKINS HOSP, Item No. 46086-20 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that inte
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
MONITORING KIT WITH 03ML FLUSH DEVICE FOR UNIV. OF NEW MEXICO, Item No. 46085-50 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces bet
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
MONITORING KIT WITH 03ML FLUSH DEVICE FOR LEHIGH VALLEY HOSPITAL CENTER, Item No. 46085-47 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that inte
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
Cardiac Catheterization Right Heart Kit w/2-Station, Right Hand, On, High Pressure Manifold and Transpac IV Disposable Transducer, Item No. 46083-03 The Transpac Disposable Straight Pressure Transduce
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
MONITORING KIT W/03ML FLUSH DEVICE FOR MEDICAL COLLEGE OF GA, Item No. 46080-51 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces betw
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
TRIPLE KIT W/SAFESET" AND 03ML FLUSH DEVICE FOR O.H.S.U., Item No. 46080-38 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
CATH LAB KIT FOR BAPTIST M. C., Item No. 46078-52 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure mo
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
Cath Lab Kit For Elkhart Hosp., Item No. 46078-17 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure mo
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
HEART KIT W/03ML FLUSH DEVICE FOR ST. JOSEPHS HOSP., Item No. 46076-59 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a cat
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
Double LINE SAFESET" KIT WITH 03ML FLUSH DEVICE FOR E.U.S.H.C., Item No. 46076-26 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces be
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
SINGLE LINE SAFESET" KIT WITH 03ML FLUSH DEVICE FOR E.U.S.H.C., Item No. 46076-25 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces be
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
TRANSDUCER KIT WITH 03ML FLUSH DEVICE FOR ALL CHILDRENS HOSP., Item No. 46076-21 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces bet
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
MONITORING KIT W/03ML FLUSH DEVICE FOR PITT CO. MEM. HOSP., Item No. 46076-19 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces betwee
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
CARDIAC CATHETERIZATION WASTE MANAGEMENT SYSTEM LEFT HEART KIT, Item No. 46073-14 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces be
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
TRIPLE PRESSURE KIT WITH 03ML FLUSH DEVICE FOR METHODIST M.C. OF ILLINOIS, Item No. 46072-51 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that in
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
RIGHT HEART CATH LAB KIT FOR BAPTIST MEM. HOSP., Item No. 46071-40 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a cathete
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
PERFUSION PUMP KIT FOR MEMORIAL HOSP., Item No. 46070-79 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pres
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
KIT W/30ML FLUSH DEVICE FOR ALL CHILDRENS Hospital, Item No. 46070-30 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a cath
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
NEONATAL KIT WITH 30ML FLUSH DEVICE FOR YALE-NEW HAVEN HOSP., Item No. 46068-65 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces betw
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
ARTERIAL SET-UP W/03ML FLUSH DEVICE FOR ORLANDO REG. MED. CTR., Item No. 46068-49 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces be
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
OPEN HEART MONITORING KIT WITH 03ML FLUSH DEVICE FOR ORLANDO REG. MED. CTR., Item No. 46068-48 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
M.K. WITH 03ML FLUSH DEVICE FOR DRISCOLL FOUNDATION CHILDRENS HOSP., Item No. 46068-02 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfac
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
RIGHT HEART KIT FOR NC BAPTIST HOSPITAL, Item No. 46066-34 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pr
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
LEFT HEART KIT FOR PORTLAND ADVENTIST HOSP., Item No. 46066-13 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter an
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
PEDIATRIC ARTERIAL KIT W/30ML FLUSH DEVICE FOR STANFORD UNIV. HOSP., Item No. 46065-65 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfac
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
ICN TRANSDUCER KIT W/30ML FLUSH DEVICE FOR STANFORD UNIV. HOSP., Item No. 46065-64 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces b
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
TRIPLE ANESTHESIA KIT W/03ML FLUSH DEVICE FOR JACKSON MEM. HOSP., Item No. 46064-54 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
OPEN HEART KIT WITH 03ML FLUSH DEVICE FOR FLETCHER ALLEN HEALTH CARE, Item No. 46063-77 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfa
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
CATH LAB KIT #3 FOR MARY HITCHCOCK HOSP., Item No. 46063-37 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and p
Terminated		 DRSK061573
Nov 15, 2016ICU Medical, Inc.
BIFURCATED TRANSPAC 4 WITH 03ML FLUSH DEVICE FOR BUFFALO GENERAL HOSP., Item No. 46063-34 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that inter
Terminated		 DRSK061573

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