10,000 results
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Precedence SPECT/CT System, Precedence 16 3/8, Upper Patient Pallet, A single photon nuclear medicine and image from an X-ray computed tomography system, Model Number: 4535 602 50851, Catalog Number: 882350, Product is manufactured by Philips Medical Systems (Cleveland), Inc. Cleveland, OH Intended use: A single photon nuclear medicine and image from an X-ray computed tomography system.
FDA Recall
Terminated
·Phillips Nuclear Medicine·Product code INQ·January 26, 2009
ArjoHuntleigh Sara Combilizer; Intended to facilitate early immobilization, rehabilitation, and care of patients.
FDA Recall
Terminated
·ARJOHUNTLEIGH POLSKA Sp. z.o.o. UI. KS. PIOTRA WAWRZYNIAKA 2 KOMORNIKI Poland·Product code INQ·June 29, 2016
IM Abbott Alinity ci-series (abdicqii) accessory driver v8.00.0001 software product that can receive information from a hospital computer system (also called a Laboratory Information System [LIS]).
FDA Enforcement
Class II
·Terminated·Data Innovations, LLC·October 31, 2018
Tibiaxys Ankle Arthrodesis Plate Compression Guide, Model #159635, part # 159 635, Batch #: EAHZ, EAJ1, ELGV, ENQE & ENQH. Product Usage: The Compression guide is a re-usable instrument used in the implantation of the Tibiaxys product. The Tibiaxys system is intended for fixation of bone fractures or for bone reconstruction (arthrodesis, osteotomies, and fractures of ankle joint, distal tibia and fibula).
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code OYK·November 17, 2011
Columbus 4-IN-1 Femoral Cutting Guide M3 Instrument (NQ083R)
FDA Enforcement
Class II
·Terminated·Aesculap, Inc.·October 24, 2012
IM Abbott Alinity ci-series (abdicqii) accessory driver v8.00.0001 software product that can receive information from a hospital computer system (also called a Laboratory Information System [LIS]).
FDA Recall
Terminated
·Data Innovations, LLC·Product code JQP·August 29, 2018
THERA PEARL 3-in-1 BREAST THERAPY, 2 hot and cold packs in plastic box. The Thera Pearl 3-in-1 Breast Therapy is a reusable therapeutic hot and cold pack for use with pain, swelling, engorgement, plugged ducts or mastitis associated with breast feeding or to help encourage let-down while using a breast pump.
FDA Enforcement
Class II
·Terminated·Lansinoh Laboratories Inc·February 13, 2013
PE CONNECTOR 5 IN 1 20/BX, Sterile, Single use, Product Usage: Catheter Connector/Accessory
FDA Enforcement
Class II
·Terminated·Teleflex Medical·May 31, 2017
Amerigel Daily Dressing Advanced 3-in-1 Hydrogel; 30 single used foil packets 1g. each; CAT # A2003. Wound management.
FDA Enforcement
Class II
·Terminated·Amerx Health Care Corp.·September 24, 2014
PERPOS 2-in-1 Drills, Catalog #6070 Component Part #6070 for PERPOS 2-in-1 Drill-a canulated, 2 step drill to be used over a K-wire to remove bone prior to the 4.5mm BONE-LOK PLS Implant (LSW-45-3040) being placed. The PERPOS 2-in-1 Drill (6070) is sold as either a component of the Single Use PERPOS PLS System (9045-01, 9045-02) or as a stand-alone tool.
FDA Recall
Terminated
·Interventional Spine Inc·Product code HTW·February 22, 2008
Skytron Infinity Series surgical light with dual lightheads, 5 bulbs in 1 - 22' lighthead and 8 bulbs in 1 - 30' diameter lighthead, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Model IF3022B. (note only the 22'' lighthead is affected.)
FDA Recall
Terminated
·Skytron, Div. The KMW Group, Inc·Product code FTD·January 8, 2007
Skytron Infinity Series surgical light with dual lightheads, 8 bulbs in 1 - 30' diameter lighthead and 5 bulbs in 1 - 22' diameter lighthead, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IN3022EL and IF3022EL. (note only the 22'' lighthead is affected).
FDA Recall
Terminated
·Skytron, Div. The KMW Group, Inc·Product code FTD·January 8, 2007
10-1398M - SpF-PLUS Implantable Stimulator. Indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels.
FDA Enforcement
Class I
·Terminated·EBI Patient Care, Inc.·May 31, 2017
Columbus 4-IN-1 Femoral Cutting Guide M3 Instrument (NQ083R)
FDA Recall
Terminated
·Aesculap, Inc.·Product code LXH·May 9, 2012
10-1335M - SpF-XL IIB 2/DM Implantable Stimulator. Indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels.
FDA Enforcement
Class I
·Terminated·EBI Patient Care, Inc.·May 31, 2017
THERA PEARL 3-in-1 BREAST THERAPY, 2 hot and cold packs in plastic box. The Thera Pearl 3-in-1 Breast Therapy is a reusable therapeutic hot and cold pack for use with pain, swelling, engorgement, plugged ducts or mastitis associated with breast feeding or to help encourage let-down while using a breast pump.
FDA Recall
Terminated
·Lansinoh Laboratories Inc·Product code IME·August 14, 2012
Transport Chair and Rollator in 1, Model HE21630011 Burgundy and HE21630011 Blue. This is a walker/rolling chair. Used to assist injured and infirm people to walk or be ambulatory.
FDA Enforcement
Class II
·Terminated·Silver Star Brands·November 26, 2014
PE CONNECTOR 5 IN 1 20/BX, Sterile, Single use, Product Usage: Catheter Connector/Accessory
FDA Recall
Terminated
·Teleflex Medical·Product code GCD·April 21, 2017
Biomet Vanguard microplasty slidex femoral 4-in-1 block, 62.5 mm, stainless steel; Ref. 32-485103.
FDA Recall
Terminated
·Biomet, Inc.·Product code HTZ·May 16, 2005
Biomet Vanguard microplasty slidex femoral 4-in-1 block, 80 mm, stainless steel; Ref. 32-485108.
FDA Recall
Terminated
·Biomet, Inc.·Product code HTZ·May 16, 2005