178 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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Miami J Select Collar, Item: MJS-101, and Miami J Select Collar Set, Item: MJSR-101 Instructions for Use
FDA Recall
Terminated
·Ossur Americas·Product code IQK·November 9, 2021
NecLoc Extrication Collar Product Usage: Necloc collars are applied to patients afflicted with cervical injuries to ensure immobilization.
FDA Recall
Terminated
·Ossur H F Grjothals 5 Reykjavik Iceland·Product code IQK·February 24, 2016
Miami J Collar Product Usage: Miami J collars are applied to patients afflicted with cervical injuries to ensure immobilization.
FDA Recall
Terminated
·Ossur H F Grjothals 5 Reykjavik Iceland·Product code IQK·February 24, 2016
Papoose Infant Spine Immobilizer Item # Item Description: PA-100 Papoose PAR-100 Papoose w/replacement pads PO-100 Papoose w/o PO front POR-100 Papoose w/o PO front w/pad Product Usage: The Papoose Infant Immobilizer is an external class I orthotic device used to securely immobilize the head and spine in the proper anatomical airway and spinal alignment. The occipital shape protects against positional plagiocephaly.
FDA Recall
Terminated
·Ossur H F Grjothals 5 Reykjavik Iceland·Product code IQK·February 24, 2016
OSSUR MIAMI J SELECT COLLAR - Product Usage: is intended to provide gross immobilization to the cervical spine. REF: MJS-101; MJSR-101
FDA Recall
Terminated
·Ossur Americas·Product code IQK·June 1, 2021
Abbott brand IntraLase Femtosecond Laser System, Model 2; Catalog Numbers: 20003D/J/K, R20003D/J/K, 20005D/J/K; Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA Product Usage: Intended Use for: IntraLase Femtosecond (Model 2 and 3) and iFS Advanced Femtosecond Laser Systems. FS Laser Systems are ophthalmic surgical lasers used in certain patient populations: (1) In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea; (2) In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments; (3) In lamellar IEK [lntraLase Enabled Keratoplasty] and corneal harvesting ; (4) In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea; (5) In the creation of a lamellar cut/resection of the cornea for lamellar IEK for the creation of a penetrating cut/incision for penetrating IEK.
FDA Recall
Terminated
·AMO Manufacturing USA, LLC·Product code HNO·October 12, 2011
Abbott brand Advanced Femtosecond Laser Systems, Model iFS, Catalog Number: J20007D/J/K; Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA Product Usage: Intended Use for: IntraLase Femtosecond (Model 2 and 3) and iFS Advanced Femtosecond Laser Systems. FS Laser Systems are ophthalmic surgical lasers used in certain patient populations: (1) In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea; (2) In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments; (3) In lamellar IEK [lntraLase Enabled Keratoplasty] and corneal harvesting ; (4) In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea; (5) In the creation of a lamellar cut/resection of the cornea for lamellar IEK for the creation of a penetrating cut/incision for penetrating IEK.
FDA Recall
Terminated
·AMO Manufacturing USA, LLC·Product code HNO·October 12, 2011
Abbott brand IntraLase Femtosecond Laser System, Model 3; Catalog Numbers: 20004D/J/K, R20004J/K; Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA Product Usage: Intended Use for: IntraLase Femtosecond (Model 2 and 3) and iFS Advanced Femtosecond Laser Systems. FS Laser Systems are ophthalmic surgical lasers used in certain patient populations: (1) In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea; (2) In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments; (3) In lamellar IEK [lntraLase Enabled Keratoplasty] and corneal harvesting ; (4) In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea; (5) In the creation of a lamellar cut/resection of the cornea for lamellar IEK for the creation of a penetrating cut/incision for penetrating IEK.
FDA Recall
Terminated
·AMO Manufacturing USA, LLC·Product code HNO·October 12, 2011
Percutaneous Insertion Tray For Use with: Arrow Ultra 8 IAB (Intra Aortic Balloon) Catheters Model: IAK-05845
FDA Recall
Terminated
·Arrow International, Inc., Division of Teleflex Medical Inc.·Product code DSP·October 11, 2010
Percutaneous Insertion Tray; Product Code: IAK-S7IT The Arrow IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle.
FDA Recall
Terminated
·Arrow International, Inc., Division of Teleflex Medical Inc.·Product code DSP·February 10, 2016
Percutaneous Insertion Tray; Product Code: IAK-06845 The Arrow IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle.
FDA Recall
Terminated
·Arrow International, Inc., Division of Teleflex Medical Inc.·Product code DSP·February 10, 2016
ARROW 50cc Drive Line Kits, REF IAK-02693, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during diastole and deflation during systole increase blood supply to the heart muscle and decrease work of the left ventricle.
FDA Recall
Terminated
·Arrow International, Inc.·Product code DSP·February 2, 2009
ARROW 40cc Drive Line Kits, REF IAK-02692, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during diastole and deflation during systole increase blood supply to the heart muscle and decrease work of the left ventricle.
FDA Recall
Terminated
·Arrow International, Inc.·Product code DSP·February 2, 2009
Vis-U-All High Temp 4"x11" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884411
FDA Enforcement
Class II
·Terminated·Steris Corporation·January 13, 2021
Vis-U-All High Temp 5"x15" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884515
FDA Enforcement
Class II
·Terminated·Steris Corporation·January 13, 2021
Vis-U-All High Temp 8"x16" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884816
FDA Enforcement
Class II
·Terminated·Steris Corporation·January 13, 2021
Vis-U-All High Temp 13"x18" Self Seal Pouch 100 pouches per box; 4 boxes per case Model Number: 884118
FDA Enforcement
Class II
·Terminated·Steris Corporation·January 13, 2021
Vis-U-All High Temperature Tubing 6"x100'. One roll per box; 10 boxes per case 10 rolls/cs Model Number: 881061
FDA Enforcement
Class II
·Terminated·Steris Corporation·January 13, 2021
Vis-U-All High Temperature Tubing 9"x100'. One roll per box; 10 boxes per case 6 rolls/cs Model Number: 881091
FDA Enforcement
Class II
·Terminated·Steris Corporation·January 13, 2021
Vis-U-All High Temp 7.5"x13" Self Seal Pouch 200 pouches per box; 4 boxes per case Model Number: 884713
FDA Enforcement
Class II
·Terminated·Steris Corporation·January 13, 2021