45 results
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25ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Parker Eclipse Probe Cover, Latex Free, REF 38-01, 10 Eclipse Probe Covers, Size: 2.37/1.75"W x 9.5"L (60/44 mm x 241 mm), Lot #D424, Expiry date 04/2016, Pre-gelled inside with Aquasonic 100 Ultrasound Transmission Gel Product Usage: For use as a protective cover for medical ultrasound probes/transducers.
FDA Enforcement
Class II
·Terminated·Parker Laboratories, Inc.·November 5, 2014
I-STAT PT/INR cartridge Abbott Point of Care Inc. Abbott Park, IL 60064 USA This cartridge is useful for monitoring patients receiving oral anticoagulation therapy such as Coumadin or warfarin.
FDA Enforcement
Class II
·Terminated·Abbott Point Of Care Inc.·August 15, 2012
Parker Eclipse Probe Cover, Latex Free, REF 38-01, 10 Eclipse Probe Covers, Size: 2.37/1.75"W x 9.5"L (60/44 mm x 241 mm), Lot #D424, Expiry date 04/2016, Pre-gelled inside with Aquasonic 100 Ultrasound Transmission Gel Product Usage: For use as a protective cover for medical ultrasound probes/transducers.
FDA Recall
Terminated
·Parker Laboratories, Inc.·Product code IYO·August 6, 2014
Biohorizons 3.0mm Overdenture Implant System, REF 30120S2, (3 mm x12 mm-2mm collar), Biohorizons Implant Systems, Inc., Birmingham, AL 35243
FDA Recall
Terminated
·BioHorizons Implant Systems Inc One Perimeter Park South·Product code DZE·April 18, 2007
BioHorizons 0.050 Hex Driver, Regular, REF 134-350, BioHorizons Implant Systems, Inc., Birmingham, AL 35243, non-sterile, Rx only. The product is part of a Prosthetic Instrumentation system Kit 51-K , Manufactured by Innovision, Inc., and the kits are assembled by BioHorizons.
FDA Recall
Terminated
·BioHorizons Implant Systems Inc One Perimeter Park South·Product code DZE·March 12, 2007
BioHorizons 0.050 Hex Driver, Regular, REF 300-350, BioHorizons Implant Systems, Inc., Birmingham, AL 35243, non-sterile, Rx only
FDA Recall
Terminated
·BioHorizons Implant Systems Inc One Perimeter Park South·Product code DZE·March 12, 2007
BioHorizons 0.050 Hex Driver, Long, REF 300-351, BioHorizons Implant Systems, Inc., Birmingham, AL 35243, non-sterile, Rx only
FDA Recall
Terminated
·BioHorizons Implant Systems Inc One Perimeter Park South·Product code DZE·March 12, 2007
BioHorizons 0.035 Hex Driver, REF 300-377, BioHorizons Implant Systems, Inc., Birmingham, AL 35243, non-sterile, Rx only, REF 300-377.
FDA Recall
Terminated
·BioHorizons Implant Systems Inc One Perimeter Park South·Product code DZE·March 12, 2007
I-STAT PT/INR cartridge Abbott Point of Care Inc. Abbott Park, IL 60064 USA This cartridge is useful for monitoring patients receiving oral anticoagulation therapy such as Coumadin or warfarin.
FDA Recall
Terminated
·Abbott Point Of Care Inc.·Product code GJS·March 1, 2012
AMD-RITMED brand Conforming Stretch Gauze Bandages, Sterile, 6 in x 4/1 yds./15 cm x 3.7 cm, Reorder Number/Code D606, Bar code 6 86864 04230 3, Made in China -- Manufactured for & distributed by: AMD-RITMED INC. Montreal Quebec H8T 3J8 -- US Distribution: AMD-RITMED INC. Tonawanda, NY 14150 -- Type of packaging: 1 roll/pouch, 12 pouches/inner box, 4 inner box/case, 48 rolls per case. Conforming bandages used to cover and protect wounds from further injuries and contamination. This type of product fits all parts of the body without restrictive movement. To be used in health care facilities.
FDA Recall
Terminated
·Amd-Ritmed, Inc.·Product code FQM·March 30, 2016
Sterile Aquasonic 100 Ultrasound Transmission Gel, 20 grams, Model Number 01-01-4, 400 packets/case
FDA Enforcement
Class II
·Terminated·Parker Laboratories, Inc.·May 16, 2018
Sterile Aquasonic 100 Ultrasound Transmission Gel, 20 grams, Model Number 01-01-4, 400 packets/case
FDA Recall
Terminated
·Parker Laboratories, Inc.·Product code IYO·April 13, 2017
AC Power Adaptor (transformer), TENPAO Model U090100Q31; used with the Pump In Style Advanced family of breast pumps; Medela Inc., McHenry, IL 60051-0650; Made in China; Article #9207010. Converting 120 Volt AC power to 9 Volt DC power used for providing power to the Pump In Style Advanced Breast pumps.
FDA Recall
Terminated
·Medela Inc·Product code OHH·April 4, 2011
i-STAT G3+ Cartridge; pH, PCO, PO. HCO2, TCO2, BE sO2; Test includes: PCO2 for calculated HCO3 and PO2 for calculated oxygen saturated/sO2. Catalog Number 220100. Abbott Point of Care Inc., Abbott Park, IL 60064 The iSTAT G3+ Cartridge is intended to be used to quantitatively measure oxygen, carbon dioxide, and pH.
FDA Recall
Terminated
·Abbott Point of Care Inc.·Product code CHL·February 23, 2009
i-STAT 1 Analyzer, Abbott Point of Care Inc., Abbott Park, IL 60064 USA, Product of USA. The product is intended to be used by trained medical professionals for use with i-STAT test cartridges and MediSense blood glucose test strips. i-STAT cartridges comprise a variety of clinical chemistry tests and test panels.
FDA Recall
Terminated
·Abbott Point of Care Inc.·Product code CGA·September 9, 2009
Fisher & Paykel Healthcare Adult Respiratory Ventilator Circuit-Dual Heated Catalogue Number RT211
FDA Recall
Terminated
·Fisher & Paykel Healthcare Inc·Product code BTT·December 20, 2005
Fisher & Paykel FlexiFit Full Face Mask, Part Numbers: HC 431A, HC431SLL, HC431SLM & HC431SLS. CPAP masks.
FDA Recall
Terminated
·Fisher & Paykel Healthcare Inc·Product code BZD·November 24, 2006
Fisher & Paykel FlexiFix Nasal Mask, Part Numbers: HC405A, HC405SL, HC405U, HCHC406A, HC406SL, HC407A, HC407SL & HC407U. CPAP masks.
FDA Recall
Terminated
·Fisher & Paykel Healthcare Inc·Product code BZD·November 24, 2006
Fisher & Paykel Healthcare Adult Respiratory Ventilator Circuit-Dual Heated Catalogue Number RT111
FDA Recall
Terminated
·Fisher & Paykel Healthcare Inc·Product code BTT·December 20, 2005
Fisher & Paykel Healthcare Adult Respiratory Ventilator Circuit-Dual Heated Catalogue Number RT110
FDA Recall
Terminated
·Fisher & Paykel Healthcare Inc·Product code BTT·December 20, 2005