16 results
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10ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
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CTX 5500 DS and CTX 2500 Explosive Detection Systems (EDS); Product is manufactured by InVision Technologies, Inc., Newark, CA
FDA Recall
Terminated
·Invision Technologies Inc·Product code ZZZ·October 7, 2005
CPAP Mask Cushion, Model Nos. PB781S, PB781M, PB781L, 781S, 781M and 781L Product Usage: A CPAP mask is attached to an end user s face and a CPAP machine, to treat end users with sleep apnea. The replacement cushion is a non-durable component that requires replacement every 3 - 6 months. The cushion is used for both comfort and to provide a seal between the face and the mask.
FDA Recall
Terminated
·Compass Health Brands (Corporate Office)·Product code BZD·June 18, 2018
CHS Custom Convenience Kit-TOENAIL REMOVAL TRAY Product Number: (1) ZZ-0956; (2) ZZ-0685
FDA Recall
Terminated
·Custom Healthcare Systems, Inc.·Product code LRO·August 13, 2018
CHS Custom Convenience Kit-TOENAIL REMOVAL TRAY Product Number: (1) ZZ-0956; (2) ZZ-0685
FDA Enforcement
Class II
·Terminated·Custom Healthcare Systems, Inc.·October 31, 2018
Terumo/Capiox Cardiovascular Kit containing the CAPIOX Disposable Centrifugal Pump The centrifugal pump is designated as TCVS Product Code 1ZZ*SP45A. The devices are assembled with PVC tubing and other devices according to individual customer specifications and then packaged into Custom Cardiovascular Procedure Kits (Convenience Kits) as follows: Convenience Kit Identifier Code/Kit Lot Numbers: 65077 FA17 62266-01 EP13 62266-01 FA31 63819-01 FC07 64034 FA03 64033 FD07 70131 FA03 70131 FA10 63607 FA31 63607 FD07 64091 FC07 64338 EP13 64338 FC07 70964 EP20 70964 FD07 70014-02 EP13 70014-02 FA03 70014-02 FC07 70014-02 FC07T 70014-02 FD07 70226-01 FD07 64987 FA24 64987 FD14 62933-01 FD14 62984-01 FA24 63004-01 FA03 63004-01 FA24 63361-01 EP27 63118 EP13 63118-01 FA24 63118-01 FC28 63118-01 FD14
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corp·Product code KFM·July 26, 2005
AXIOM Vertix MD Trauma systems radiographic X-ray
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code IZZ·March 5, 2014
Diagnost 94
FDA Recall
Terminated
·Philips Medical Systems·Product code IZZ·February 20, 2002
Multidiagnost 96
FDA Recall
Terminated
·Philips Medical Systems·Product code IZZ·February 20, 2002
AXIOM Multix MT (model number 8395415 or 8395399 or 8395381), a patient table used in conjunction with the Siemens Multix PRO- and TOP Systems radiographic exposures of the entire body.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code IZZ·August 6, 2018
Diagnost 94
FDA Recall
Terminated
·Philips Medical Systems Sales & Service Region No. America·Product code IZZ·August 10, 2003
Multidiagnost 97
FDA Recall
Terminated
·Philips Medical Systems·Product code IZZ·February 20, 2002
Diagnost 96
FDA Recall
Terminated
·Philips Medical Systems Sales & Service Region No. America·Product code IZZ·August 10, 2003
Non-sterile Viscot Surgical Skin Markers Part Number 1437-100 Non-sterile Viscot Part Number 143-100 Surgical Skin Markers are pen-like devices intended to be used to write on the patient's skin, e.g., to outline surgical incision sites or mark anatomical sites for accurate blood pressure measurement; available in nonsterile configuration.
FDA Recall
Terminated
·Precision Dynamics Corporation·Product code FZZ·July 10, 2013
Dual Tip Marker, Sterile Product Usage: A writing instrument intended to mark paper and plastic items around the sterile field during surgery. It has two tips. One is black for miscellaneous use. The other is for surgical skin marking.
FDA Recall
Terminated
·Viscot Medical LLC·Product code FZZ·August 22, 2012
Diagnost 97
FDA Recall
Terminated
·Philips Medical Systems Sales & Service Region No. America·Product code IZZ·August 10, 2003
GE Medical Systems, COMPAX 40E X-ray Systems, Models; 2208203, 2208205, 2244282, 2244284, 2225863, 2225864 , 2225865, 2225870, 2225881, and 2225882. Intended to be used for general purpose radiography and tomography.
FDA Recall
Terminated
·GE Medical Systems, LLC·Product code IZZ·July 30, 2009