114 results
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16ms
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Sources: EU EUDAMED, US FDA
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Angiotech Drainage Cather. SKATER Centesis Cather XFr. STERILE. Product Number: 700304007, 700304010, 700304015, 700305007, 700305010, 7003015. 510k Exempt. Qty Dist. - 4,250. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 Southwest 74th Avenue, Gainesville, Florida 32608 U.S.A. Intended Use: Drainage Cather
FDA Recall
Terminated
·Medical Device Technologies, Inc.·Product code JCY·September 1, 2009
***REF 24k100***QTY 1***24k Arthroscopy Outflow/Suction Tubing Set***MADE IN USA***Rx Only***CONMED LINVATEC, CONMED LINVATEC 11311 CONCEPT BLVD, LARGO, GL 33773-4900*** For use in conjunction with the ConMed Linvatec 24k Pump, for pump-induced outflow and/or suction of fluid from the joint during arthroscopic procedures.
FDA Recall
Terminated
·Linvatec Corp. dba ConMed Linvatec·Product code JCY·September 10, 2010
1113 Gravity Tube Set Pk/24 -SH Product Usage: The FMS Gravity Tube Set is intended to deliver irrigation fluid from irrigation containers to the operative site during arthroscopic procedures.
FDA Recall
Terminated
·DePuy Mitek, Inc., a Johnson & Johnson Co.·Product code JCY·August 31, 2017
Smiths Medical, BCI Remote Alarm Cable (Normally Open & Normally Closed), Reorder Numbers: WW3398NO & WW3398NC. For use with respiration carbon dioxide measurement equipment. Product Usage: The BCI Remote Alarm Cable is designed for use with the 9004 Capnocheck Capnography (Plus or Sleep) system to transfer alarm signals from the Capnocheck Capnography system to a remote alarm system. The BCI Remote Alarm Cable and the 9004 Capnocheck Capnography systems are intended for use in all critical environments including ventilatory applications, patient transport, and anesthesia.
FDA Recall
Terminated
·Smiths Medical ASD, Inc.·Product code CCK·February 6, 2013
BCI Advisor Vital Signs Monitor (Model/Catalog Number: 9200)
FDA Recall
Terminated
·Smiths Medical PM, Inc.·Product code MWI·June 5, 2007
CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW8214
FDA Recall
Open, Classified
·Smiths Medical ASD, Inc.·Product code CCK·February 14, 2025
BCI Non Invasive Blood Pressure Monitor Product/Catalog number 6004,
FDA Recall
Terminated
·Smiths Medical PM, Inc.·Product code DXN·April 2, 2008
CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW1100
FDA Recall
Open, Classified
·Smiths Medical ASD, Inc.·Product code CCK·February 14, 2025
Smiths Medical, BCI Advisor Vital Signs Monitor, Product Reorder No 92M774325A.
FDA Recall
Terminated
·Smiths Medical ASD, Inc.·Product code CCK·March 21, 2015
ACL TOP CTS PN 000280020 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters.
FDA Recall
Terminated
·Instrumentation Laboratory Co.·Product code GKP·August 13, 2010
ACL TOP (Base) PN 000280000 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters
FDA Recall
Terminated
·Instrumentation Laboratory Co.·Product code GKP·August 13, 2010
ACL TOP 500 CTS PN 000280040 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters.
FDA Recall
Terminated
·Instrumentation Laboratory Co.·Product code GKP·August 13, 2010
ACL TOP 700 LAS PN 000280030 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters.
FDA Recall
Terminated
·Instrumentation Laboratory Co.·Product code GKP·August 13, 2010
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
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01ML2. Part number: 414538. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast.
FDA Recall
Terminated
·Biomerieux Inc·Product code LTW·June 14, 2013
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01ML1. Part number: 414537. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast.
FDA Recall
Terminated
·Biomerieux Inc·Product code LTW·June 14, 2013
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 ZH. Part number: 414569. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast.
FDA Recall
Terminated
·Biomerieux Inc·Product code LTW·June 14, 2013
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 PT. Part number: 414566. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast.
FDA Recall
Terminated
·Biomerieux Inc·Product code LTW·June 14, 2013
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit V2S RP5800XPE TO 6.01 WES7. Part number: 6201773. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast.
FDA Recall
Terminated
·Biomerieux Inc·Product code LTW·June 14, 2013
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 ES. Part number: 414561. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast.
FDA Recall
Terminated
·Biomerieux Inc·Product code LTW·June 14, 2013