17 results
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56ms
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Sources: EU EUDAMED, US FDA
PULSE BIOMEDICAL INC, QRS CARD S-T SEGMENT ANALYSIS MONITORING SYSTEM
FDA 510(k)QRS Card 12 Lead Resting & Stress ECG Machine with Blue Tooth (wireless) interface. Cardiology Suite (CS 4.0) Software is used with the machine.
FDA Recall
Terminated
·Pulse Biomedical Inc·Product code LOS·March 5, 2007
BCI 3303 HAND HELD PULSE OXIMETER
FDA Adverse Event
Malfunction
·SMITHS MEDICAL PM, INC.·Product code DQA·June 30, 2009
BCI 3180 Pulse Oximeter uses power cord WW3005 (Electri-Cord Manufacturing Co., 312 E. Main St., Westfield, PA 16950).
FDA Recall
Terminated
·Smiths Medical PM, Inc. N7·Product code DQA·January 15, 2010
ERBE APC 2
FDA Adverse Event
Injury
·ERBE ELEKTROMEDIZIN GMBH·Product code GEI·January 9, 2009
ERBE APC 2
FDA Adverse Event
Injury
·ERBE ELEKTROMEDIZIN GMBH·Product code GEI·February 11, 2010
Medtronic Dual Chamber Temporary Pacemaker, model 5388. Manufacturer: Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604, USA.
FDA Recall
Terminated
·Medtronic Inc. Cardiac Rhythm Disease Managment·Product code LWP·October 11, 2010
DIALOG A + HE/BIC
FDA Adverse Event
Injury
·B. BRAUN AVITUM AG - MELSUNGEN·Product code FKJ·July 22, 2016
9200 Advisor Vital Signs Monitor uses power cord WW3005 (Electri-Cord Manufacturing Co., 312 Main St., Westfield, PA 16950).
FDA Recall
Terminated
·Smiths Medical PM, Inc. N7·Product code CCK·January 15, 2010
8400 Capnocheck Capnometer uses power cord 8404 (Electri-Cord Manufacturing, 312 E. Main St, Westfield, PA 16950) for its battery charger 330.
FDA Recall
Terminated
·Smiths Medical PM, Inc. N7·Product code CCK·January 15, 2010
BEAR III
FDA Adverse Event
BEAR MEDICAL SYSTEMS INC.·Product code BTL·May 17, 1993
Patient Circuit used with the Life Pulse High Frequency Ventilator. The Patient Circuit is a required disposable component of the Life Pulse High Frequency Ventilator. Model #(s): Individual Patient Circuit - catalog # 902 Patient Circuit Kit - catalog # 937: contains 2 circuits and 2 x 2.5 & 2 x 3.5 LifePort Adapters. Labeling states manufactured by: Bunnell Incorporated 436 Lawndale Drive, Salt Lake City, Utah 84115. Used for ventilating critically ill infants with pulmonary interstitial emphysema and infants with respiratory distress syndrome complicated by pulmonary air leaks, who are, in the opinion of their physicians, failing on conventional ventilation. The Patient Circuit is to provide a conduit for the humidification, warming, and temperature monitoring of the pressurized gas. The Patient Circuit is indicated for seven day single use.
FDA Recall
Terminated
·Bunnell, Inc.·Product code LSZ·November 19, 2012
Umedwings Netherlands B.V.
Importer
🇳🇱 Netherlands·36 Manufacturers
Emergo Europe B.V.
Authorized representative
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Shanghai International Holding Corp. GmbH(Europe)
Authorized representative
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MedNet EC-REP GmbH
Authorized representative
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Importer
🇷🇴 Romania·49 Manufacturers