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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Persona Trabecular Metal Tibia; Persona Trabecular Metal Tibial Plate Instruments and Modular Brackets; Used to facilitate the implantation of joint replacement implants.
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·June 15, 2016
SoftPath Laboratory Information System. Versions 4.3.0.8, 4.3.0.9, 4.3.0.10, 4.3.0.11, 4.3.0.12, 4.3.0.14, 4.3.0.15, and 4.4.0.0
FDA Enforcement
Class II
·Terminated·SCC Soft Computer·February 18, 2015
epoc BGEM Test Card (Catalogue number CT-1004-00-00). quantitative testing of samples for pH, pCO2, pO2, Sodium Potassium , Ionized Calcium, Glucose, Lactate and Hematocrit.
FDA Enforcement
Class II
·Terminated·Epocal·August 21, 2013
Microscan Synergies Plus Negative Urine Combo 2 Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for gram-negative bacteria.
FDA Enforcement
Class I
·Terminated·Siemens Healthcare Diagnostics, Inc.·September 18, 2013
Minor Ortho Pack, Kit number 002646-12 and 002646-13 convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016
Major Ortho Pack, kit number 002647-12 and 002647-13 convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016
ORBIT PT. The ORBIT PT works in conjunction with an TRUMPF mobile operating table to automate the patient transport process.
FDA Recall
Terminated
·Trumpf Medical Systems·Product code JEA·July 24, 2013
LPC Fine Mesh Cassette for the Leica LPC Printer. Part No: 14060546848; 14060546846; 14060546845; 14060546933; 14060546932; 14060546852; 14060546850; 14060546847. The intended use of this device is for storage of specimens/tissues during processing.
FDA Recall
Terminated
·Leica Microsystems, Inc.·Product code IDZ·April 4, 2013
The Constellation Vision System Pneumatic Handpiece. Indicated for both anterior and posterior segment opthalmic surgery.
FDA Recall
Terminated
·Alcon Grieshaber AG Winkelriedstrasse 52 Schaffhausen Switzerland·Product code HQE·April 17, 2013
FAST Procedure Kit. Intended for use as a Minor Surgical Procedures Tray.
FDA Recall
Terminated
·American Optisurgical Inc·Product code OJU·April 30, 2013
Crocodile (size 3) are two-armed, wheeled walking aids, used by children with disabilities. Product Usage: The Crocodile is a walking aid for children with disabilities, who need supplementary assistance with their daily walking. The Crocodile is available in three sizes and can be used for children between the ages of 2 to 18 years.
FDA Recall
Terminated
·Snug Seat Inc·Product code IOR·August 26, 2013
Stryker Vision Mounting Arm, for use with other Stryker Endoscopy medical device products for human patients. Model number 0240-095-200, manufactured by Stryker Endoscopy San Jose The intended use of the Stryker Vision Mount is to hold and position an LCD monitor. The Stryker Vision Mounting Arm can be used with any Stryker flat panel display and is It is compatible with Stryker Carts (0240099001, 0240099011 or 0240099020). It is indicated for use in a surgical operating room environment and is exposed to environmental conditions associated with the storage and shipping of the product. It is not intended to enter the sterile field. The Stryker Vision Mount does not deliver to and/or extract from the patient any energy or material. It does not process any biological materials, as it is not intended to be sterilized by the user. The Stryker Vision Mount is only used to display surgical images and video and does not sustain or support life.
FDA Recall
Terminated
·Stryker Endoscopy·Product code BZN·August 30, 2013
DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Shoulder Blanket w/ Straps NS, REF T655NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849. Physical Therapy.
FDA Recall
Terminated
·DeRoyal Industries Inc·Product code ILO·September 17, 2013
DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee Blanket w/ Straps NS, REF T654NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849. Physical Therapy.
FDA Recall
Terminated
·DeRoyal Industries Inc·Product code ILO·September 17, 2013
Trabecular Metal" Reverse Shoulder System
FDA Recall
Terminated
·Zimmer, Inc.·Product code KWT·October 17, 2013
DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee/Shoulder Blnkt NS, REF T653NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849. Physical Therapy.
FDA Recall
Terminated
·DeRoyal Industries Inc·Product code ILO·September 17, 2013
DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee/Shoulder Blanket NS, REF T652NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849. Physical Therapy.
FDA Recall
Terminated
·DeRoyal Industries Inc·Product code ILO·September 17, 2013
Code Alert Advanced 4-Way Care Solution, CA520 System, PN 9600-1600, RF Technologies. This product is used to alert caregivers when a patient at risk for falls is leaving a bed or chair.
FDA Recall
Terminated
·RF Technologies, Inc.·Product code KMI·May 17, 2013
Aquarius (TM) TEMPERATURE THERAPY, REF T650, Rx Only, Manufactured for DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, Made in China. Physical Therapy.
FDA Recall
Terminated
·DeRoyal Industries Inc·Product code ILO·September 17, 2013
DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Foot/Ankle Blanket NS, REF T656NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849. Physical Therapy.
FDA Recall
Terminated
·DeRoyal Industries Inc·Product code ILO·September 17, 2013