10 results
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20ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Microstream SMART CAPNOLINE PLUS O2 LONG 100 UN Part Number: 010341 010341 Part Number: 10341
FDA Recall
Terminated
·Oridion Medical·Product code cck·May 26, 2010
Microstream O2/CO2 NASAL FILTERLINE ADULT LONG O2 CONN 100UN Part Number: 010343 010341 Part Number: 10341
FDA Recall
Terminated
·Oridion Medical·Product code cck·May 26, 2010
Unicel DxC 600i System and Unicel Dxl 600 Access Immunoassay System
FDA Recall
Terminated
·Beckman Coulter Inc·Product code CFR·April 3, 2008
Access and Access 2 Immunoassay System
FDA Recall
Terminated
·Beckman Coulter Inc·Product code CGN·April 3, 2008
UniCel Dxl 800 Access Immunoassay System and UniCel DxC 880i Synchron Access Clinical System
FDA Recall
Terminated
·Beckman Coulter Inc·Product code JJE·April 3, 2008
SYNCHRON LXi 725 System
FDA Recall
Terminated
·Beckman Coulter Inc·Product code JGS·April 3, 2008
Instructions For Use document of the GPS Trackers.
FDA Enforcement
Class II
·Terminated·Blue Ortho·November 4, 2020
Oridion CO2 sampling lines and water traps under the label: MicroStreamC02 Sampling Lines: FilterLine Set Adult/Pediatric -Part No: XS04620-01; FilterLine Set Adult/Pediatric (100 unit boxes)-Part No. 010579; FilterLine H Set Adult/Pediatric -Part No. XS04624 ; FilterLine H Set Adult/Pediatric (100 unit boxes) Part No: 010580; FilterLine H Set Infant/Neonatal-Part No. 006324; FilterLine Set Adult/Pediatric Long Part No. 007768; FilterLine H Set Adult/Pediatric Long Part No. 007737; FilterLine H Set Infant/Neonatal Long Part No. 007738 Smart CapnoLine Plus (O2 connector) Part No. 009818 Smart CapnoLine Plus (O2 connector) (Special 100 unit boxes) - Part No.; 010209; Smart CapnoLine Plus Long (O2 connector) Part No. 010340; Smart CapnoLine Plus Long (O2 connector) (Special 100 unit boxes) Part No: 010339; Smart CapnoLine Plus O2 (O2 tubing) Part No. 009822 Smart CapnoLine Plus O2 (O2 tubing) (Special 100 unit boxes) Part No. 010210; Smart CapnoLine Plus O2 Long (O2 tubing) Part No. 009826; Smart CapnoLine Plus O2 Long (O2 tubing) (Special 100 unit boxes) , Part No. 010341; Smart CapnoLine Pediatric Part No. 007266 Smart CapnoLine O2 Pediatric (O2 tubing) Part No. 07269; Smart CapnoLine O2 Pediatric Long (O2 tubing) Part No.007743; Smart CapnoLine H Plus O2 (O2 tubing) Part No. 010433; Smart CapnoLine H O2 Adult (O2 tubing) Part No. 010478; Smart CapnoLine H O2 Intermediate (O2 tubing) Part No; 010475; Smart CapnoLine H Pediatric (O2 connector) Part No. 010581; Smart CapnoLine H O2 Pediatric (O2 tubing) Part No. 010582 O2 CO2 Nasal FilterLine Adult (O2 connector) Part No. 010207; O2 CO2 Nasal FilterLine Adult (O2 tubing) Part No. 006912; O2 CO2 Nasal FilterLine Adult Long (O2 connector) Part No. 010342; O2 CO2 Nasal FilterLine Adult Long (O2 tubing) Part No. 007739; O2 CO2 Nasal FilterLine Pediatric (O2 tubing) Pat No. 006913; O2 CO2 Nasal FilterLine Long (O2 tubing) Part No 007740; NIV Line Adult Part No. 008174; NIV Line Pediatric Part No. 008175; Nasal FilterLine Infant/Neonatal Part No. XS0447; CapnoLine H Adult Part No. 008177; CapnoLine H Pediatric Part No. 008178; CapnoLine H Infant/Neonatal Part No. 008179; CapnoLine H O2 Adult (O2 tubing) Part No. 008180; CapnoLine H O2 Pediatric (O2 tubing) Part No. 008181; CapnoLine H O2 Infant/Neonatal (O2 tubing) Part No. 012111; VitaLine H Set Adult/Pediatric Part No. 010787; VitaLine H Set Infant/Neonatal Part No. 010807; FilterLine XL Part No. 006325; Smart CapnoLine Guardian Part No. 012528; Smart CapnoLine Guardian O2 Part No. 012529; Smart CapnoLine Guardian O2 Long Part No. 012530
FDA Recall
Terminated
·Oridion Medical·Product code CCK·February 16, 2012
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013