33 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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Thermoplastic templates, single tooth Catalog Number: 040.526
FDA Recall
Terminated
·Straumann Manufacturing Inc.·Product code DZJ·January 30, 2006
Stryker brand Consolidated Operating Room Equipment (CORE) System Powered Instrument Driver, REF 5400-50; Model 5400-050-000.
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code DZJ·August 5, 2005
Stryker brand Consolidated Operating Room Equipment (CORE) SystemPowered Instrument Driver, REF 5400-50; Model 5400-050-000A.
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code DZJ·August 5, 2005
Right/Left IBO Blade Set, for use with Stryker TPS Reciprocating Saw, REF 5100-37-903, Stryker Instruments, Kalamazoo, MI. Product Usage: The intended use of these devices is to cut bone and hard tissue in maxillofacial procedures and have been specifically designed for osteotomies of the mandibular ramus.
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code DZJ·October 18, 2011
Thermoplastic templates, free-end situation Catalog Number: 040.527
FDA Recall
Terminated
·Straumann Manufacturing Inc.·Product code DZJ·January 30, 2006
Left IBO Blade , for use with Stryker TPS or Core Reciprocating Saw, REF 5100-37-902S2, Stryker Instruments, Kalamazoo, MI. Product Usage: The intended use of these devices is to cut bone and hard tissue in maxillofacial procedures and have been specifically designed for osteotomies of the mandibular ramus.
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code DZJ·October 18, 2011
IBO Blade, Right, for use with Stryker TPS Reciprocating Saw, REF 5100-37-901, Stryker Instruments, Kalamazoo, MI. Product Usage: The intended use of these devices is to cut bone and hard tissue in maxillofacial procedures and have been specifically designed for osteotomies of the mandibular ramus.
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code DZJ·October 18, 2011
REF 5100-088, TPS Micro Driver, For Use with Stryker Total Performance System Caution Federal Law (USA) restricts the device to use by or on the order of a physician Driver, Wire and Bone Drill; The Stryker Total Performance System (TPS) is intended for use in the cutting, drilling, reaming, decorticating and smoothing of bone and other bone related tissues for a variety of applications such as ENT, dental, orthopedic, maxillofacial, spinal, and plastic surgery. The instruments are also used in the placement of screws, wires, pins, and other fixation devices.
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code DZJ·October 2, 2013
IBO Blade, Left, for use with Stryker TPS Reciprocating Saw, REF 5100-37-902, Stryker Instruments, Kalamazoo, MI. Product Usage: The intended use of these devices is to cut bone and hard tissue in maxillofacial procedures and have been specifically designed for osteotomies of the mandibular ramus.
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code DZJ·October 18, 2011
Right IBO Blade , for use with Stryker TPS Reciprocating Saw, REF 5100-37-901S2, Stryker Instruments, Kalamazoo, MI. Product Usage: The intended use of these devices is to cut bone and hard tissue in maxillofacial procedures and have been specifically designed for osteotomies of the mandibular ramus.
FDA Recall
Terminated
·Stryker Instruments Div. of Stryker Corporation·Product code DZJ·October 18, 2011
AVID TruCustom DJ'S VASCULAR/NEURO TRAY convenience kits, Item Code: AV010930-12
FDA Recall
Terminated
·Avid Medical, Inc.·Product code LRO·June 22, 2017
AVID TruCustom DJ'S VASCULAR/NEURO TRAY convenience kits, Item Code: AV010930-12
FDA Enforcement
Class II
·Terminated·Avid Medical, Inc.·March 7, 2018
AMS AST For the In vitro quantitative determination of AST in serum Quantitative determination of AST in serum.
FDA Recall
Terminated
·AMS Diagnostics, LLC·Product code NJT·February 11, 2014
AMS BUN UREA NITROGEN For the In vitro quantitative determination of Urea Nitrogen in serum Quantitative determination of Bun in serum.
FDA Recall
Terminated
·AMS Diagnostics, LLC·Product code NJT·February 11, 2014
AMS URIC ACID For the In vitro quantitative determination of Uric Acid in serum Quantitative determination of Uric Acid in serum.
FDA Recall
Terminated
·AMS Diagnostics, LLC·Product code NJT·February 11, 2014
ADVIA Salicylate (SAL) reagent chemistry assay; use in the quantitative determination of salicylate in human serum and plasma (lithium heparin). Product Number: 10327382 (Mfr: Sekisui Diagnostics)
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code DKJ·June 29, 2017
Salicylate Reagent (SALY 2 x 45), Catalog No. 378194. Intended for quantitative determination of salicylate concentration in human serum or plasma.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code DKJ·April 3, 2017
Maximo Concepts Alcohol Breath Tester, Model Number: MAX91721, Sakar International, Inc., Edison, NJ (LED 3 Step Alcohol Breath Tester)
FDA Recall
Terminated
·Sakar International, Inc.·Product code DJZ·November 30, 2007
0.10% BreathScan Alcohol Detector manufactured for WNCK, Inc., The Woodlands, TX by Howard Industries, Inc., Columbus, OH (crystals) and James Alexander Corp., Blairstown, NJ (general device assembly). Product sold in bulk and individually packaged. Bulk product (500-1000 units) distributed in unlabeled clear plastic bags. Individually packaged product packaged and sealed in clear plastic bags with labeling and sold in boxes containing 100 units/box.
FDA Recall
Terminated
·WNCK, Inc·Product code DJZ·November 30, 2005
TDx/TDxFLx Salicylate, list 9533-60; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064
FDA Recall
Terminated
·Abbott Laboratories HPD/ADD/GPRD·Product code DKJ--·December 5, 2003