188 results
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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SOMATOM Edge Plus with software syngo.CT VB20 Model #10267000
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·December 1, 2021
SOMATOM Confidence, Model Number 10590100 Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·May 8, 2019
SOMATOM Definition Edge, Model Number 10590000 Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·May 8, 2019
SOMATOM Edge Plus, Model Number 10267000 Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·May 8, 2019
SOMATOM Edge Plus, Model Number 10267000 - Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained physician as an aid in diagnosis. The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning. These CT systems can be used for low dose lunch cancer screening in high risk populations (as defined by professional medical societies).
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·August 21, 2019
SOMATOM Definition AS with Option syngo DE Scan for Single Source (Dual Spiral Dual Energy scan mode), Model Number 8098027 Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·May 8, 2019
Philips HeartStart MRx monitor/defibrillators Models: M3535A, M3536A, M3536M4, M3536M5, and M3536M6 Product Usage: The Heartstart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician
FDA Enforcement
Class II
·Terminated·Philips Healthcare Inc.·July 4, 2012
ProVue Instrument Driver for JResultNet (ProVue.jrm) v. 1.5.3 and below JResultNet is a stand-alone software package that provides connectivity between in-vitro diagnostic instruments (IVDs) and Laboratory Information Systems (LIS) aiding the flow of laboratory information, including test orders and results, specimen information, and patient information.
FDA Enforcement
Class II
·Terminated·Data Innovations, LLC·September 24, 2014
***CAT 7205305***DYONICS***Arthroscopic Blade***3.5mm FULL RADIUS, 13cm long***Fits Power/EP-1 Motor Drives***Beige***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lakeland, FL*** Lot number: 199468***Expiration Date: 12/2011. ***CAT 7205306***DYONICS***Arthroscopic Blade***4.5mm FULL RADIUS, 13cm long***Fits Power/EP-1 Motor Drives***Yellow***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lakeland, FL*** Lot number: 185659***Expiration Date: 08/2011. ***CAT 7205307***DYONICS***Arthroscopic Blade***5.5mm FULL RADIUS, 13cm long***Fits Power/EP-1 Motor Drives***Orange***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lakeland, FL*** Lot number: 197755***Expiration Date: 12/2011. Reprocessed arthroscopic shavers are indicated for use in orthopedic surgical procedures of the joints, jaw or sinuses where cutting and removal of soft and hard tissue or bone is needed in patients requiring orthopedic surgery.
FDA Recall
Terminated
·Ascent Healthcare Solutions·Product code HRX·January 26, 2009
(1)Traverse Rail Carrier E-System, wide 31017XX component to Liko overhead lift, (2)Traverse Rail Carrier 31025XX component to Liko overhead lift. Intended for to make safe lifting of a patient possible. Affected Devices: 3101704 TRAV RAIL CARR E-SYST STD 3102514 TR CARRIER SLIM/RAISED, LR 3101705 TRAV RAIL CARR ESYST WIDE 3102517 TR CARR. NORMAL/LOWER. LR 3102506 TR CARRIER WIDE/RAISED ML 3102519 TR CARR. LOW.LR 30MM/PAIR 3102511 TR CARRIER NORMAL, LR 3102531 TRAVERSE RL CARRIER STD/RAISED 3102512 TR CARRIER WIDE, LR 3102532 TRAVERSE RL CARRIER WD/RAISED 3102513 TR CARRIER SLIM, LR 3102562 TR CARRIER, PARALLEL/WIDE
FDA Enforcement
Class II
·Terminated·Hill-Rom, Inc.·March 23, 2022
***CAT 7205314***DYONICS***Arthroscopic Blade***5.5mm INCISOR, 13cm long***Fits Power/EP-1 Motor Drives***Mocha***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lakeland, FL*** Lot number: 197849***Expiration Date: 12/2011. Reprocessed arthroscopic shavers are indicated for use in orthopedic surgical procedures of the joints, jaw or sinuses where cutting and removal of soft and hard tissue or bone is needed in patients requiring orthopedic surgery.
FDA Recall
Terminated
·Ascent Healthcare Solutions·Product code HRX·January 26, 2009
***CAT 7205316***DYONICS***Arthroscopic Blade***4.5mm TURBOWHISKER, 13cm long***Fits Power/EP-1 Motor Drives***Navy Blue***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lakeland, FL*** Lot number: 197855***Expiration Date: 12/2011. Reprocessed arthroscopic shavers are indicated for use in orthopedic surgical procedures of the joints, jaw or sinuses where cutting and removal of soft and hard tissue or bone is needed in patients requiring orthopedic surgery.
FDA Recall
Terminated
·Ascent Healthcare Solutions·Product code HRX·January 26, 2009
***CAT 7205345***DYONICS***Arthroscopic Blade***4.5mm INCISOR PLUS, 13cm long***Fits Power/EP-1 Motor Drives***Violet***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lakeland, FL*** Lot number: 197940***Expiration Date: 12/2011. Reprocessed arthroscopic shavers are indicated for use in orthopedic surgical procedures of the joints, jaw or sinuses where cutting and removal of soft and hard tissue or bone is needed in patients requiring orthopedic surgery.
FDA Recall
Terminated
·Ascent Healthcare Solutions·Product code HRX·January 26, 2009
***CAT 7205310***DYONICS***Arthroscopic Blade***4.5mm SYNOVATOR, 13cm long***Fits Power/EP-1 Motor Drives***Forest Green***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lakeland, FL*** Lot number: 197854***Expiration Date: 12/2011. Reprocessed arthroscopic shavers are indicated for use in orthopedic surgical procedures of the joints, jaw or sinuses where cutting and removal of soft and hard tissue or bone is needed in patients requiring orthopedic surgery.
FDA Recall
Terminated
·Ascent Healthcare Solutions·Product code HRX·January 26, 2009
PKG, ROTATING HANDLE, W/RATCHET, INSULATED SHAFT, P/N 0250080234. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014
Vector TAS Modular Driver, a manual driver for Vector TAS dental screws.
FDA Recall
Terminated
·Ormco/Sybronendo·Product code DZN·December 12, 2011
Sunquest Laboratory SMART & Sunquest Laboratory SMART Select Product Usage: for clinical use
FDA Recall
Terminated
·Sunquest Information Systems, Inc.·Product code JQP·August 12, 2011
Respironics SealFlex Single Port Ribbed Mask (Infant). For general use in respiratory and anesthesia applications as a conduit for various gases to resuscitate or to enhance breathing abilities of the patient. .
FDA Recall
Terminated
·Engineered Medical Systems, Inc·Product code BSJ·September 12, 2011
Siemens AXIOM Aristos FX Plus solid state x-ray imager. Image-intensified fluoroscopic x-ray system.
FDA Recall
Terminated
·Siemens Medical Solutions USA, Inc·Product code MQB·December 12, 2011
Elekta Leksell Gamma Knife C 1.2, 4 and 4C Product Usage: Leksell Gamma Knife is a teletherapy device intended for stereotactic irradiation of head structures.
FDA Recall
Terminated
·Elekta, Inc.·Product code IWB·May 26, 2011