44 results
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15ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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ANAX 5.5 Poly-Reduction Screw 6.0X50MM, REF: SFNA6050R, part of ANAX 5.5 SPINAL SYSTEM
FDA Enforcement
Class II
·Terminated·U&I CORP.·July 29, 2020
ANAX 5.5 Poly-Reduction Screw 6.0X50MM, REF: SFNA6050R, part of ANAX 5.5 SPINAL SYSTEM
FDA Recall
Terminated
·U & I CORP. 20 Sandan-Ro 76 Beon-Gil Uijeongbu Korea (the Republic of)·Product code NKB·May 26, 2020
AXS Infinity LS Long Sheath:((6F/.088in)/ x 70cm GEN-10800-70, (6F/.088in)/ x 80cm GEN-10800-80, (6F/.088in)/ x 90cm GEN-10800-90) Made in Ireland, Sterile EO. The AXS Infinity LS Long Sheath system contents are: One (1) AXS Infinity LS Long Sheath, One (1) Hemostasis valve with extension tubing, One Long Dilator.
FDA Enforcement
Class II
·Terminated·Stryker Neurovascular·October 10, 2018
AXS Infinity LS Long Sheath:((6F/.088in)/ x 70cm GEN-10800-70, (6F/.088in)/ x 80cm GEN-10800-80, (6F/.088in)/ x 90cm GEN-10800-90) Made in Ireland, Sterile EO. The AXS Infinity LS Long Sheath system contents are: One (1) AXS Infinity LS Long Sheath, One (1) Hemostasis valve with extension tubing, One Long Dilator.
FDA Recall
Terminated
·Stryker Neurovascular·Product code DQY·May 2, 2018
X-Guide Surgical Navigation System, X-Clip Bulk Kit The X-Guide Surgical Navigation System is a computerized navigational system intended to provide assistance in both the preoperative planning phase and the intra-operative surgical phase of dental implantation procedures.
FDA Enforcement
Class II
·Terminated·X-NAV Technologies, LLC·April 20, 2016
Medisystems 17 Gauge x 1" inch AV Fistula Needle Product Code: D9-2007MGLB Product Usage: Medisystems AVF with MasterGuard anti-stick needle protector is indicated for use as a vascular access device in hemodialysis or other extracorporeal procedures. It is intended for use in conjunction with a blood tubing set equipped with a standard medical male luer-locking connector
FDA Enforcement
Class II
·Terminated·Medisystems a NX Stage Company·January 30, 2013
Medisystems 15 Gauge x 3/5 inch Buttonhole Needle Set Product Code: BH-2035PE Product Usage: Medisystems Buttonhole Needle Sets are indicated for use as an access device for dialysis and pheresis procedures using a constant site orbuttonhole method of needle insertion.
FDA Enforcement
Class II
·Terminated·Medisystems a NX Stage Company·January 30, 2013
Part #: SAM XT-C, Model: Hi-Viz Orange or Civilian
FDA Recall
Terminated
·The Seaberg Company Inc·Product code GAX·May 2, 2018
CAP Change Kit w/MicroClave Clear, Item No. B78109 BD prefilled syringes are co-packaged into a kit with ICU devices and other components. The affected lots are easily identifiable via the lot number printed on the pouch.
FDA Recall
Terminated
·ICU Medical, Inc.·Product code GAX·August 5, 2014
Part #: SAM XT-M, Model: Tactical Black or Military
FDA Recall
Terminated
·The Seaberg Company Inc·Product code GAX·May 2, 2018
SUNSTAR Butler Clear Dip, 16 FL OZ, SKU #716PA
FDA Recall
Terminated
·Sunstar Americas, Inc.·Product code EAX·March 23, 2021
Tourni-Cot - Universal, UDI 00855364004085, Model Number TCU, Non-pneumatic Tourniquet - Product Usage: The device is intended to be used in surgery on fingers or toes to provide a blood-less field.
FDA Recall
Terminated
·Mar-Med Co·Product code GAX·December 28, 2020
Cap Change Kit with MicroClave Clear Connector, Item No. B79103 BD prefilled syringes are co-packaged into a kit with ICU devices and other components. The affected lots are easily identifiable via the lot number printed on the pouch.
FDA Recall
Terminated
·ICU Medical, Inc.·Product code GAX·August 5, 2014
Part #: SAM XT-C, Model: Hi-Viz Blue
FDA Recall
Terminated
·The Seaberg Company Inc·Product code GAX·May 2, 2018
MATResponder Tourniquet; Catalog number MATR: UPC 78353 00008; MATCombat Tourniquet, Catalog number MATC; UPC 78353 00010; MATResponder Tourniquet and MATCombat Tourniquet are essentially the same product with different color schemes manual nonpneumatic tourniquet devices. The device provides for emergency blood flow occlusion to the limbs
FDA Recall
Terminated
·Pyng Medical Corporation 210-13480 Crestwood Pl Richmond Canada·Product code GAX·August 31, 2015
Port Access Kit with MicroClave Clear Connector, Item No. B79104 BD prefilled syringes are co-packaged into a kit with ICU devices and other components. The affected lots are easily identifiable via the lot number printed on the pouch.
FDA Recall
Terminated
·ICU Medical, Inc.·Product code GAX·August 5, 2014
Bag Tee Assembly Model P1407A . An accessory to the dental flowmeter which has a connection function for complete delivery of mixed gases to the breathing circuit portion of the gas scavenging apparatus. The Bag Tee assembly features a non-breathing valve and an Emergency Air Intake located on the bag tee which comply with the American Dental Association guidelines.
FDA Recall
Terminated
·Porter Instrument Co Inc·Product code CAX·August 26, 2008
Medisystems 15 Gauge x 3/5 inch Buttonhole Needle Set Product Code: BH-2035PE Product Usage: Medisystems Buttonhole Needle Sets are indicated for use as an access device for dialysis and pheresis procedures using a constant site orbuttonhole method of needle insertion.
FDA Recall
Terminated
·Medisystems a NX Stage Company·Product code FIE·December 20, 2012
Medisystems 17 Gauge x 1" inch AV Fistula Needle Product Code: D9-2007MGLB Product Usage: Medisystems AVF with MasterGuard anti-stick needle protector is indicated for use as a vascular access device in hemodialysis or other extracorporeal procedures. It is intended for use in conjunction with a blood tubing set equipped with a standard medical male luer-locking connector
FDA Recall
Terminated
·Medisystems a NX Stage Company·Product code FIE·December 20, 2012
Ottobock Modular Polycentric EBS Knee Joint 3R60, 3R60=ST, 3R60=KD, 3R60=HD. Used for the prosthetic fitting of amputations of the lower. limb.
FDA Recall
Terminated
·Otto Bock Healthcare GmbH Max-Nader-Str. # 15 Duderstadt Germany·Product code ISY·January 4, 2016