13 results
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20ms
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Sources: EU EUDAMED, US FDA
ANSPACH***REF 98-0012***Shoulder Implant 011mm Rod, 20cm Long, Custom***Rx Only*** This device is intended to be used with Anspach Systems
FDA Recall
Terminated
·The Anspach Effort, Inc.·Product code KWR·November 28, 2012
Bucky Stand SU-4000 Input 2017.11.17. SU41711085 Date: 2017-11-17; Board Name; Board Version, Firmware Version Advanced Universal U-Arm 4000 System. The Positioner consists of the following associated subassemblies: Vertical Column, Swivel Arm with variable height, X-ray Tube, Automatic Exposure Control, Collimator, Touch Screen Control and Image Receptor Assembly. The Positioner and the Patient Mobile Table are associated equipment to the Generator X-ray Unit.
FDA Recall
Terminated
·Konica Minolta Healthcare, Americas, Inc.·Product code IXY·November 8, 2018
LKT200 Perfusion Circuit, part of Lifeport Kidney Perfusion Transporter KTR - Product Usage: The circuit is an accessory to LifePort Kidney Perfusion Transporter (KTR) Isolated kidney perfusion and transport system, which is intended to be used for the continuous hypothermic machine perfusion of kidneys for the preservation, transportation and eventual transplantation into a recipient.
FDA Recall
Terminated
·Organ Recovery Systems, Inc.·Product code KDN·January 30, 2020
Genesis Straight Esthetic 4.0 mm 1mm Cuff Abutment Part Number: G71200 Genesis implant for single stage or two stage surgical procedures all types of of bone in partially or fully edentulous mandibles and maxillae.
FDA Recall
Terminated
·Keystone Dental Inc·Product code NHA·July 5, 2011
Genesis Straight Esthetic 5.0 mm 3. mm Cuff Abutment Part Number: G71205 Genesis implant for single stage or two stage surgical procedures all types of of bone in partially or fully edentulous mandibles and maxillae.
FDA Recall
Terminated
·Keystone Dental Inc·Product code NHA·July 5, 2011
CDI Blood Parameter Monitoring System 500 including all Catalog Numbers to include: Catalog # 500AVHCT with Arterial and Venous blood parameter modules and Hematocrit/Saturation probe. Catalog Number 500AHCT, CDI 500 Monitor with Arterial blood parameter module and Hematocrit/Saturation probe. Catalog Number 500AV CDI 500 Monitor with Arterial and Venous blood parameter modules; and Catalog 500A, CDI 500 Monitor with Arterial blood parameter module. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and /or venous pH, PCO2, K+, or oxygen saturation, hematocrit, hemoglobin, and temperature are desired.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DRY·September 23, 2011
Odyssey Femoral Holder/Driver, Part Number K001-7410, Non-sterile, 1 each, Wright Medical Technology, Inc., 5677 Airline Road, Arlington, TN 38002
FDA Recall
Terminated
·Wright Medical Technology Inc·Product code HWR·October 4, 2007
BIOMET MICROFIXATION, PATIENT DISTRACTOR DRIVER 10.87cm, (4.28")(L), RADEL, STAINLESS STEEL, NON-STERILE PRODUCT. Part Number SP-1918 BIOMET MICROFIXATION 1520 TRADEPORT DRIVE, JACKSONVILLE, FL 32218 USA.
FDA Recall
Terminated
·Biomet Microfixation, Inc.·Product code HWR·January 15, 2010
Biosure Driver, Product No: 72201887 For delivery and placement of orthopedic screws. Orthopedic Manual Surgical Instrument
FDA Recall
Terminated
·Smith & Nephew, Inc., Endoscopy Div.·Product code HWR·April 4, 2013
Pioneer Quantum Spinal Rod System, MIS Yoke Manipulator, Long Slot, non-sterile; Cat # 51-YOKEMAN-L, Pioneer Surgical Technology, Marquette, MI 49855
FDA Recall
Terminated
·Pioneer Surgical Technology·Product code HWR·October 10, 2007
Oxford Unicompartmental Knee Phase 3 Tibial Impactor Product Usage: Instruments for use with the Oxford Uni Partial Knee System
FDA Recall
Terminated
·Biomet U.K., Ltd. Waterton Industrial Estate Bridgend South Wales United Kingdom·Product code HWR·January 5, 2016
Rabbit Kidney Culture, brand name: 'FreshCells'. The product is labeled as 'Rabbit Kidney' also known as 'Rbk' , 2-square cm area of a cell monolayer covered with 2-mL culture medium. The product is packed in glass culture tubes 16x125mm, with screw caps. The product is distributed in EPS shipping racks which can hold up to 50 tubes each. Used routinely for in vitro diagnostic testing for virus and/or Chlamydia isolation and to aid in the diagnosis of diseases associated with infectious agents.
FDA Recall
Terminated
·Diagnostic Hybrids Inc·Product code KIR·January 21, 2009
Oxford Partial Knee System Phase 3 Tibial Template Right Medial Size A Product Usage: Instruments for use with the Oxford Uni Partial Knee System
FDA Recall
Terminated
·Biomet U.K., Ltd. Waterton Industrial Estate Bridgend South Wales United Kingdom·Product code HWR·January 5, 2016