128488
|
Z-2113-2014
|
Terminated
|
MVC
|
2014-07-01
|
Biogenex Laboratories, Inc.
|
InSite HER-2 Detection Kit, an immunohistochemistry assay for in vitro diagnostic use.
|
128754
|
Z-2089-2014
|
Terminated
|
MAV
|
2012-05-10
|
Perouse Medical 135, Route Neuve Irigny France
|
Perouse Flamingo, Model 0218TA and 0218TB intended for use during cardiovascular procedure to create, maintain and monitor pressure in the balloon catheter.
|
128396
|
Z-2142-2014
|
Terminated
|
IWZ
|
2014-07-02
|
Carestream Health Inc.
|
INSIGHT Dental Film, Catalog Number/REF 811 0785, KODAK and Carestream DENTAL labels --- Carestream Health Inc.
|
133407
|
Z-1169-2015
|
Terminated
|
OEZ
|
2015-01-09
|
Navilyst Medical, Inc
|
NAMIC Convenience Kit, UPN H749601308341, REF/Catalog No. 60130834, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588.
Product Usage:
NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.
|
133422
|
Z-1183-2015
|
Terminated
|
OEZ
|
2015-01-09
|
Navilyst Medical, Inc
|
NAMIC Convenience Kit, LEFT HEART KIT, UPN H749601900431, REF/Catalog No. 60190043, STERILE, Rx ONLY ---For single use only. --- Device Listing Number D136588.
NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.
|
133753
|
Z-1193-2015
|
Terminated
|
OEZ
|
2015-01-09
|
Navilyst Medical, Inc
|
NAMIC Convenience Kit, LEFT HEART KIT, UPN H9656002072121, REF/Catalog No. 600207212, STERILE, Rx ONLY --- For single use only. ---Device Listing Number D136588.
NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.
|
133827
|
Z-1213-2015
|
Terminated
|
EFW
|
2015-02-03
|
Norwex Usa Inc
|
Manual Toothbrush; SilverCare Junior 2/6 years Antibacterial Toothbrush Made in Italy
The product is intended for over the counter use as a toothbrush. The silver plating is an antimicrobial agent which maintains the cleanliness of the brush by preventing growth of bacteria on and between the filaments after use.
|
133754
|
Z-1194-2015
|
Terminated
|
OEQ
|
2015-01-09
|
Navilyst Medical, Inc
|
NAMIC Convenience Kit, ANGIO DOUBLE SPIKE KIT, UPN H9656003028111, REF/Catalog No. 600302811, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136683.
NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.
|
130256
|
Z-1073-2015
|
Terminated
|
FRN
|
2014-07-02
|
Hospira Inc.
|
The Plum A+ Infusion System is designed to meet the fluid delivery requirements of today's evolving healthcare environments. It is a cassette based multi-function infusion system. The Plum A+ allows two lines in and one line out. The pump can be used for standard, piggyback, or concurrent delivery. Therapy modes include: Standard Infusions, Multistep Programming, Loading Dose, and Dose Calculation. The Plum A+ is designed to deliver parenteral, enteral, or epidural infusions over a broad range of infusion rates from multiple fluid container types. Each system includes a pumping module and an assortment of disposable IV sets, optional accessories, and an operator's manual.
|
133403
|
Z-1166-2015
|
Terminated
|
OEZ
|
2015-01-09
|
Navilyst Medical, Inc
|
NAMIC Convenience Kit, LEFT HEART CATH KIT, UPN H7496010018151, REF/Catalog No. 601001815, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588.
Product Usage:
NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.
|
133761
|
Z-1201-2015
|
Terminated
|
OEZ
|
2015-01-09
|
Navilyst Medical, Inc
|
NAMIC Convenience Kit, PTCA KIT, UPN H9656019110161, REF/Catalog No. 601911016, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588.
NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.
|
134175
|
Z-1336-2015
|
Terminated
|
FGE
|
2015-02-25
|
Boston Scientific Corporation
|
Boston Scientific: Expel" Drainage Catheter with Twist-Loc" Hub APDL Drainage Catheter and APDL Drainage Catheter Kit, Expel" Drainage Catheter APD Drainage Catheter, Expel" Large Capacity Drainage Catheter APD Large Capacity Drainage Catheter.
|
134496
|
Z-1322-2015
|
Terminated
|
ISW
|
2015-02-26
|
Ossur H F Grjothals 5 Reykjavik Iceland
|
The Rheo Knee bionic prosthetic is to be used exclusively for fittings of lower extremity amputations. RHEO KNEE uses Artificial Intelligence to continuously adapt to the users walking style and environment. The RHEO KNEE recognizes and responds immediately to changes in speed, load and terrain, restoring the users ability to walk naturally, comfortably and confidently at any speed.
|
134071
|
Z-1324-2015
|
Terminated
|
OVE
|
2015-02-20
|
TITAN SPINE, LLC
|
Endo TCS Driver Straight Hexalobe #6 P/N 5210-1004, Non-Sterile, Manufactured by Titan Spine, LLC.
Endo TCS driver is one of the instruments within the surgical tray for use with the Interbody Fusion Device(IBD).
|
134353
|
Z-1316-2015
|
Terminated
|
IYE
|
2015-02-16
|
Brainlab AG Kapellenstrasse 12 Feldkirchen Germany
|
ExacTrac versions 6.x patient positioning systems are used to position patients during radiosurgery or radiotherapy procedures..
|
134545
|
Z-1338-2015
|
Terminated
|
FYA
|
2015-03-10
|
Microtek Medical Inc
|
FREEDOMAIRE(R) MOTOR MODULE, REF 11112STK, QTY 1/CS, NON STERILE, NO LATEX
The Surgical Helmet System is intended to be worn by surgical personnel to provide barrier between the operating environment and the surgical personnel in order to protect against contamination, body fluids and microorganisms.
|
132886
|
Z-1076-2015
|
Terminated
|
FTL
|
2014-08-26
|
MAST Biosurgery USA, Inc
|
The SurgiWrap Bioresorbable Adhesion Barrier Film. SurgiWrap 100x130x0.05mm
(01) 18964050255027
(17) 170731(10)52804
LOT 52804 2017-08 REF25502-01
Product is wrapped in a foil pouch that is then sealed into an additional envelope.
|
132409
|
Z-1082-2015
|
Terminated
|
FOZ
|
2015-01-02
|
Arrow International Inc
|
ARROWg+ard Blue PLUS Pressure Injectable Two-Lumen CVC Kit. The Multiple-Lumen Catheter permits venous access to the central circulation by way of the femoral jugular, or subclavian veins.
|
132772
|
Z-1095-2015
|
Terminated
|
BTT
|
2015-01-14
|
Teleflex Medical
|
Hudson RCI¿ Humidifier Adaptor, 040 contained in the following units: HUMIDIFIER ADAPTOR 040
Product Usage:
The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.
|
132230
|
Z-1084-2015
|
Terminated
|
FWZ
|
2014-12-19
|
Integra LifeSciences Corporation
|
The MAYFIELD¿ Ultra 360 Base Unit for head positioner, one unit per package.
Product Usage:
This product provides the ability to position and hold a patient head while the patient is in the prone, supine, lateral or park-bench and sitting positions. It is intended to be used during diagnostic examinations or surgical procedures where a rigid support between the surgical table and a headrest or skull clamp is necessary and positional freedom is required.
|