300 results
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10ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Thermo Scientific General Purpose Dynamic Bath Precision 5 & 10L Dual GP Bath Model Number: TSGP15D
FDA Recall
Terminated
·Thermo Fisher Scientific (Asheville) LLC·Product code JTQ·April 2, 2019
Fisher Scientific Isotemp -General Purpose Water Bath: lsotemp 20L GP Bath Model Number: FSGPD20
FDA Recall
Terminated
·Thermo Fisher Scientific (Asheville) LLC·Product code JTQ·April 2, 2019
Thermo Scientific General Purpose Dynamic Bath Precision 20L GP Bath Model Number: TSGP20
FDA Recall
Terminated
·Thermo Fisher Scientific (Asheville) LLC·Product code JTQ·April 2, 2019
Thermo Scientific General Purpose Dynamic Bath Precision 10L GP Bath Model Number: TSGP10
FDA Recall
Terminated
·Thermo Fisher Scientific (Asheville) LLC·Product code JTQ·April 2, 2019
Thermo Scientific General Purpose Dynamic Bath Precision 2L-Shallow GP Bath Model Number: TSGP2S
FDA Recall
Terminated
·Thermo Fisher Scientific (Asheville) LLC·Product code JTQ·April 2, 2019
Thermo Scientific General Purpose Dynamic Bath Precision 28L GP Bath Model Number: TSGP28
FDA Recall
Terminated
·Thermo Fisher Scientific (Asheville) LLC·Product code JTQ·April 2, 2019
Fisher Scientific Isotemp -General Purpose Water Bath: lsotemp 10L GP Bath Model Number: FSGPD10
FDA Recall
Terminated
·Thermo Fisher Scientific (Asheville) LLC·Product code JTQ·April 2, 2019
Thermo Scientific General Purpose Dynamic Bath Precision 5L GP Bath Model Number: TSGP05
FDA Recall
Terminated
·Thermo Fisher Scientific (Asheville) LLC·Product code JTQ·April 2, 2019
Fisher Scientific Isotemp -General Purpose Water Bath: lsotemp 5L GP Bath Model Number: FSGPD05
FDA Recall
Terminated
·Thermo Fisher Scientific (Asheville) LLC·Product code JTQ·April 2, 2019
CO2 Incubators (General Purpose Incubator), model numbers 370, 371, 380, 381, 3307, 3308, 3310, 3311, 3540, 3541, 3542, 3543, 3584, 3585, 3598, and 3599. Product Usage: Incubators are designed to maintain an optimal environment for the incubation of tissue and cell samples. These models are designed to maintain temperature, carbon dioxide, and humidity levels.
FDA Recall
Terminated
·Thermo Fisher Scientific (Asheville) LLC·Product code JTQ·November 29, 2012
Ovation iX Abdominal Stent Graft Systems, REF: TV-AB2080-I, TV-AB2080-J, TV-AB2380-I, TV-AB2380-J, TV-AB2680-I, TV-AB2680-J, TV-AB2980-I, TV-AB2980-J, TV-AB3480-I, TV-AB3480-J
FDA Enforcement
Class I
·Terminated·Endologix, Inc.·June 17, 2020
JTS External Drive Unit JTS Distal Femoral Extendible Implant Femur is intended for the replacement of diseased or deficient bone in the distal femur.
FDA Enforcement
Class II
·Terminated·Stanmore Implants Worldwide Ltd.·September 13, 2017
Surface Applicator Set with Leipzig-style Cone. Brachytherapy applicator set.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems Inc·July 1, 2015
The VariSource iX series afterloader systems are computer controlled remote electro/mechanical systems used for medical purposes, for placing a cable incorporating an irradiated iridium seed internally or close by a malignant tumor or tumor bed in a practice known as brachytherapy.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems Inc·July 8, 2015
MEDRAD Sterile Disposable Syringe Kit Recall, Catalog Number 150-FT-Q; Kit includes angiographic injector and syringe The contents of the package are intended to be used in the delivery of contrast media.
FDA Recall
Terminated
·Medrad Inc·Product code DXT·May 17, 2010
Kinamed SuperCable Grip and Plate System Driver, 3.5mm Hex, Catalog Number: 35-860-2060 The driver is intended to be used in conjunction with compression and locking bone screws for fixation of long bone fractures when Kinamed Trochanteric Grips & Cable-Plates are used. Subsequent Product Codes: HWC, JDQ.
FDA Recall
Terminated
·Kinamed Inc·Product code KTT·August 18, 2010
Philips HeartStart FRx 861304 Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA; and Laerdal branded FRx 861305 The FRx Defibrillator is intended to treat ventricular fibrillation, the most common cause of sudden cardiac arrest. Using voice prompts, light emitting diodes (LEDs) and buttons, the user is guided through the response. The FRx uses a SMART biphasic, impedance compensating exponential waveform to deliver a nominal 150 J to adults and nominal 50 J to infants/children.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems North America Co. Phillips·January 16, 2013
Philips and Laerdal brands of HeartStart HS1 Defibrillator Family Model number M5066A, M5067A, and M5068A Automated External Defibrillator Manufactured by Philips Medical Systems, Seattle, WA 98121 USA. The HS1 Defibrillator is intended to treat ventricular fibrillation, the most common cause of sudden cardiac arrest. Using voice prompts, light emitting diodes (LEDs) and buttons, the user is guided through the response. The HS1 uses a SMART biphasic, impedance compensating exponential waveform to deliver a nominal 150 J to adults and nominal 50 J to infants/children.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems North America Co. Phillips·January 16, 2013
Hamilton brand Disposable Syringe Pack for use with Microlab F.A.M.E; Part Number: 147692 (case containing 96 syringes); Manufactured by: Treff AG, Degersheim, Switzerland for Hamilton Bonaduz AG, Bonaduz, Switzerland (Manufacturer of record); Product is distributed by Hamilton Company, Reno, NV The F.A.M.E Syringes are a disposable product that is used on our Microlab F.A.M.E. series instruments for diluting/dispensing. Microlab F.A.M.E was released under 510(k) K943493/S1 under product codes JJE (862.2160 Discrete Photometric Chemistry Analyzer for Clinical Use), JJQ (862.2300 Colorimeter, photometer, or spectrophotometer for Clinical Use), and JTC (866.2500 Microtiter Diluting/Dispensing Device), all of which are currently Class I exempt devices. The syringes are also used on Ortho Summit Processor instruments distributed by Ortho-Clinical Diagnostics.
FDA Recall
Terminated
·Hamilton Co·Product code JJE·September 26, 2011
Posey Biothane Restraint Cuffs, Catalog Number 2900. The device is intended to limit a patient's movement to the extent necessary for treatment or protection of the patient or others.
FDA Enforcement
Class II
·Terminated·J T Posey Company·April 17, 2013