53 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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AIA Analyzer Pipette Tips used on Tosoh AIA-2000, AIA-1800, AIA-900 and AIA-600II Analyzers, 1000 tips/bag AIA-Analyzer Tips are disposable pipette tips packaged in bulk quantities and used on Tosoh Bioscience AIA Analyzers for lab analysis of various immunoassays.
FDA Enforcement
Class II
·Terminated·Tosoh Smd Inc·August 7, 2013
ARGENT SURGICAL SYSTEMS***BIOPSY Punches*** Disposable manual instrument for skin biopsy.
FDA Enforcement
Class II
·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013
Walgreens Quick Read Digital Thermometer; an electronic digital thermometer; Model WIC551226
FDA Recall
Terminated
·Walgreen Company·Product code FLL·November 23, 2011
Smith & Nephew, HD1200 Autoclavable Camera Head Catalog Number: 72203360 Product Usage: Endoscope & Accessories
FDA Recall
Terminated
·Smith & Nephew, Inc. Endoscopy Division·Product code GCJ·September 23, 2011
Midmark M11 Ultra Steam Sterilizer, Distributed by: Midmark Corporation, 60 Vista Drive, Versailles, Ohio 45380. Sterilize reusable equipment that is heat and moisture stable.
FDA Recall
Terminated
·Midmark Corportation·Product code FLE·October 24, 2011
V24-00400-29 cable, an accessory to the Newport HT50 ventilator. The V24-00400-29 cable is an accessory to the Newport HT50 ventilator intended to transfer the alarm signal from the ventilator to a nurse remote station.
FDA Recall
Terminated
·Flight Medical Ltd.·Product code CBK·August 10, 2011
Elekta Leksell Gamma Plan Product Usage: Gamma Plan is a computer based system designed for Gamma Knife treatment planning.
FDA Recall
Terminated
·Elekta, Inc.·Product code IWB·June 23, 2011
LANTIS Commander, LANTIS Commander 6.1, LANTIS 8.3 Commander, LANTIS System, LANTIS 6.1 Complete, LANTIS 6.1 Essential, LANTIS 8.3 Complete and LANTIS 8.3 Essential. Distributed by Siemens, Concord, CA Mfg by Impac Medical Systems, Sunnyvale, CA Electronic patient records management system
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code LMB·March 23, 2011
KCI RotoProne Critical Care Therapy System buckles for securing patient to the surface during proning therapy, Model 209500. Indicated for treatment and prevention of pulmonary complications.
FDA Recall
Terminated
·KCI USA, Inc.·Product code IKZ·February 18, 2011
SpineFrontier S-Lift Lock Shaft Inserter, an instrument used with S-LIFT Intervertebral Body Fusion Device in spinal fusion surgery. Product Usage: The S-Lift Lock Shaft SI50001 mates with SI50002, Implant Inserter, to aid in securing the implant to the whole implant inserter assembly, SI50000.
FDA Recall
Terminated
·SpineFrontier, Inc.·Product code MAX·December 23, 2011
Synthes Spine Zero-P Instruments and Implants. Zero-profile anterior cervical interbody fusion (ACIF) device.
FDA Recall
Terminated
·Synthes USA (HQ), Inc.·Product code ODP·September 23, 2011
Circumcision Clamp, models 1.1 cm and 1.3 cm, Circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant.
FDA Recall
Terminated
·Surgical Design Inc·Product code HFX·January 26, 2011
Game Ready Professional Therapy System, a cryotherapy device. Intended to treat postsurgical and acute injuries to reduce edema, swelling and pain where indicated.
FDA Recall
Terminated
·CoolSystems, Inc.·Product code IRP·August 23, 2011
Marathon Flow Directed Micro Catheter, Model #105-5055. Product Usage: The Marathon Flow Directed Micro Catheter is intended to access the peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization materials and of diagnostic materials such as contrast media.
FDA Recall
Terminated
·Micro Therapeutics Inc, Dba Ev3 Neurovascular·Product code KRA·September 23, 2011
GE LOGIQ P6 Ultrasound System. The device is intended for use by a qualified physician for the evaluation of soft tissue and blood flow in the clinical applications of: Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal (TE); Transrectal (TR); Transvaginal (TV); and intraoperative (abdominal, thoracic, vascular and neurological).
FDA Recall
Terminated
·GE Healthcare, LLC·Product code IYN·December 23, 2011
UltraFlow HPC Flow Directed Micro Catheter, Model # 105-5065. Product Usage: The UltraFlow HPC Flow Directed Micro Catheter is intended to access peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization materials and of diagnostic materials such as contrast media.
FDA Recall
Terminated
·Micro Therapeutics Inc, Dba Ev3 Neurovascular·Product code KRA·September 23, 2011
Kyphon brand KyphoPak Express Tray First Fracture, 15/2 with KyphX Osteo Introducer System; Catalog Number: KPE1003; Product is manufactured and distributed by Medtronic Spine LLC (formerly known as Kyphon Inc), Sunnyvale, CA Designed to reduce kyphosis that results from vertebral body collapse due to osteoporosis.
FDA Recall
Terminated
·Medtronic Spine LLC (formerly Kyphon Inc.)·Product code HRX·March 23, 2011
Low Profile Self-Tapping Bone Screw, 6.5 mm X 25 mm, Qty. 1, Biomet Orthopedics, 66 East Bell Drive, P.O. Box 587, Warsaw, IN 46581 USA. STERILE. To provide fixation of any acetabular cup, with appropriate sized screw holes, to the pelvic bone during total hip replacement procedures.
FDA Recall
Terminated
·Biomet, Inc.·Product code HWD·March 10, 2011
Accessories for the Captiva Spine SmartLOX Cervical Plate System. Products are labeled in part: "***Part Number CP40012***12mm Drill Bit***Lot Number 89427-2 R***" "***Part Number CP40014***14mm Drill Bit***Lot Number 89427-3-R***" The Captiva Spine SmartLOX Cervical Plate System is intended for the anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion.
FDA Recall
Terminated
·Captiva Spine, Inc 967 Alternate A1A Suite1·Product code KWQ·November 22, 2011
GemStar SP Infusion Suite Database, Version 1.0; an Rx PC software application; Hospira, Inc., Lake Forest, IL 60045; list 13092-04-01 A stand-alone PC application for administration of medications specific to the GemStar Infuser
FDA Recall
Terminated
·Hospira Inc.·Product code FRN·March 23, 2011