9 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Digital RID Plate Reader and Software Product Code: AD400
FDA Recall
Terminated
·The Binding Site Group, Ltd.·Product code JZQ·October 9, 2012
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
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
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
ThermiSense model 5700-A5 The ThermiSense Model 5700-A5 is a nasal cannula that detects thermal variation during breathing cycles and transmits those variations to a remote Alice-5 Polysomnograph via electrical connectors to monitors an adult patient's breathing rate in a sleep laboratory study
FDA Recall
Terminated
·Salter Laboratories, Division of Regulatory Affairs·Product code BZQ·December 21, 2010
Battery Pack Respironics Model 915 for use in the 900 Series SmartMonitor and the 900 Series Pulse Oximeter.
FDA Recall
Terminated
·Respironics, Inc.·Product code BZQ·June 4, 2004
ActiveLife One-Piece Drainable Pouch with Stomahesive Skin Barrier; 1 1/4 in., 32mm; Made in Dominican Republic; ConvaTec. Colostomy pouch
FDA Recall
Terminated
·Convatec Inc.·Product code EZQ·September 17, 2010
Model 511 Cardio Respiratory Monitor with Oximax technology with software version 5.0
FDA Recall
Terminated
·CAS Medical Systems, Inc.·Product code BZQ·May 24, 2004