48 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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ConMed Linvatec Biomaterials, PopLok bone Punch PKL-35M, 3.5mm Orthopedic manual surgical instrument - Bone Punch
FDA Enforcement
Class II
·Terminated·Linvatec Corp. dba ConMed Linvatec·February 13, 2013
ConMed Linvatec Biomaterials, PopLok bone Punch PKL-35M, 3.5mm Orthopedic manual surgical instrument - Bone Punch
FDA Recall
Terminated
·Linvatec Corp. dba ConMed Linvatec·Product code LXH·November 15, 2012
ARTHROSCOPY PK L/F 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code OJH·July 10, 2015
PopLok Punch labeled in part: "PKL-35M***3.5mm***QTY 1***PopLok Punch***ConMed Linvatec Biomaterials, Ltd. Hermiankatu 6-8L 33720 Tampere, FINLAND***Rx Only***ConMed Linvatec 11311 Concept Blvd Largo, FL 33773-4908 USA***Made in USA***" Intended Use: Bone Punch.
FDA Enforcement
Class II
·Terminated·Linvatec Corp. dba ConMed Linvatec·August 15, 2012
ARTHROSCOPY PK L/F 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate
FDA Enforcement
Class II
·Terminated·Customed, Inc·September 9, 2015
PopLok Punch labeled in part: "PKL-35M***3.5mm***QTY 1***PopLok Punch***ConMed Linvatec Biomaterials, Ltd. Hermiankatu 6-8L 33720 Tampere, FINLAND***Rx Only***ConMed Linvatec 11311 Concept Blvd Largo, FL 33773-4908 USA***Made in USA***" Intended Use: Bone Punch.
FDA Recall
Terminated
·Linvatec Corp. dba ConMed Linvatec·Product code LXH·July 6, 2012
US Endoscopy Padlock Clip defect closure system Ref: C910001 The Padlock Clip is indicated for use in flexible endoscopy and for the compression of tissue in the gastrointestinal tract, for hemostasis or for treating lesions of the wall of the gastrointestinal organs.
FDA Recall
Terminated
·US Endoscopy Group Inc·Product code PKL·February 4, 2019
Roche VANC2, Online TDM Vancomycin, for use with the Roche/Hitachi Cobas c 501analyzer; Catalog No.04491050190.
FDA Recall
Terminated
·Roche Diagnostics Corp.·Product code LEH·April 30, 2007
Roche VALP2, Online TDM Valproic acid , for use with the Roche/Hitachi Cobas c 501 analyzer; Catalog No.04491041190.
FDA Recall
Terminated
·Roche Diagnostics Corp.·Product code LEG·April 30, 2007
Covidien Clearify Visualization System Item Code: 21-345 Intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope as well as clean the scope lens
FDA Enforcement
Class II
·Terminated·Medtronic·December 28, 2016
Synthes Material Mix (Adjustable Cervical Distractor-Right, Matrix Distractor Rack, T-PAL Spacer Remover, Implant Inserter) Synthes Material Mix: Adjustable Cervical Distractor-Right is used to distract spine segment. Matrix Distractor Rack is used to distract the interbody disc space. T-PAL Spacer Remover is used to remove T-PAL spacer. Implant Inserter is used to insert the ProDisc implant.
FDA Enforcement
Class II
·Terminated·Synthes USA HQ, Inc.·December 4, 2013
Synthes Material Mix (Adjustable Cervical Distractor-Right, Matrix Distractor Rack, T-PAL Spacer Remover, Implant Inserter) Synthes Material Mix: Adjustable Cervical Distractor-Right is used to distract spine segment. Matrix Distractor Rack is used to distract the interbody disc space. T-PAL Spacer Remover is used to remove T-PAL spacer. Implant Inserter is used to insert the ProDisc implant.
FDA Recall
Terminated
·Synthes USA HQ, Inc.·Product code LXH·October 15, 2013
Stryker Orthopaedics PAL Pelvic Alignment Level, Ref: PAL 400; Howmedica Osteonics Corp, 325 Corporate Drive, Mahwah, NJ 07430. Intended to determine proper anatomical orientation, selection, alignment and position of the acetabular and femoral components.
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code IQO·September 11, 2007
MicroAire PAL¿ Cannula Product Usage - Power Aspiration Device
FDA Enforcement
Class II
·Terminated·MicroAire Surgical Instruments, LLC·April 13, 2016
MicroAire PAL Cannula Product Usage - Power Aspiration Device
FDA Recall
Terminated
·MicroAire Surgical Instruments, LLC·Product code GEA·February 8, 2016
Precision Aspheric Lens (PAL) Intraocular Lens Model: EC-3 PAL, Serial Number: 1169381106, 1169391106, 1169421106 The device is indicated for primary implantation in the capsular bag of the eye for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed.
FDA Recall
Terminated
·Aaren Scientific, Incorporated·Product code HQL·August 2, 2011
Allen Medical Systems PAL Pro Stirrups Catalog Number: A-10051-A1
FDA Recall
Terminated
·The OR Group, Inc. A Subsidiary of Hill-Rom Inc. One Post Office Square·Product code FWZ·June 2, 2003
MicroAire PAL-R4011XL - 40cm x 4 mm Del Vecchio French Rasp aspiration cannula
FDA Enforcement
Class II
·Terminated·MicroAire Surgical Instruments, LLC·April 13, 2016
MicroAire PAL-R4011XL - 40cm x 4 mm Del Vecchio French Rasp aspiration cannula
FDA Recall
Terminated
·MicroAire Surgical Instruments, LLC·Product code BTA·February 8, 2016
Synthes Spine T-PAL Spacer System. Transforaminal posterior atraumatic lumbar spacer system. Transforaminal posterior atraumatic lumbar spacer system. Synthes T-PAL Spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combined with supplemental fixation. The interior of the T-PAL Spacer should be packed with autogeneous bone graft (i.e. autograft). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.
FDA Recall
Terminated
·Synthes USA (HQ), Inc.·Product code MAX·September 23, 2011