88 results
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13ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
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Shoulder Arthroscopy Pack, Kit number 002648-15, 002648-16, AMS2496, AMS2496(A, AMS2609, PSS2209(A, and PSS2209(B. convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016
GE Healthcare, Aisys CS2 anesthesia..
FDA Recall
Terminated
·GE Medical Systems, LLC·Product code BSZ·February 17, 2016
GE Healthcare, Aisys Carestation.
FDA Recall
Terminated
·GE Medical Systems, LLC·Product code BSZ·February 17, 2016
Breast Pack, Kit part number AMS3238, AMS3238(A, AMS3691, AMS4419, PSS1541, PSS1784, PSS1784(A, PSS1784(B, PSS2272, and PSS2272(A. convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016
Integra MicroFrance Monopolar and Bipolar Electrosurgical Instruments
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corp.·June 8, 2016
Fluorocell PLT reagent, Catalog #CD994563 Fluorocell PLT is used to stain platelets in a diluted blood sample for the counting of platelets with the Sysmex XN-Series automated hematology analyzers
FDA Enforcement
Class II
·Terminated·Sysmex America Inc·September 21, 2016
Major Breast Pack, Kit number AMS3409 convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016
Podiatry Pack, Kit number AMS1541, AMS2778, PSS2645, and PSS3422 convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016
enGen (TM) Laboratory Automation System configured with Thermo Scientific Recapper Module (230V or 110V -- COMMON/USUAL NAME: enGen (TM) Track System -- NOTE: Outside the US the system is also known as VITROS Automation Solution (VAS) TC Automation System (configured with Thermo Scientific Recapper Module from VITROS Automation Solutions), Product Code 6844300 --- The enGen (TM) Lab Automation System is a modification to VITROS Analyzers that includes the addition of an automated track sub-system (TC Automation) for pre-analytical and post-analytical sample and data management. In addition to an Automated Track Sub-system, the enGen (TM) System includes one or more VITROS Chemistry, Immunodiagnostic and/or Integrated Systems (clinical analyzers) as well as a Data Management Subsystem (Middleware), and a Software Configuration (gsb) File. The enGen System is typically interfaced with a Laboratory Information System (LIS) via connectivity facilitated at the Data Management Subsystem level. The enGen (TM) Laboratory Automation System contains a module (i.e. enGen (TM)Laboratory Automation Recapper Module) that applies caps to the sample collection container after the sample has been aspirated. In this module, an electrical cable supplies power to the cap vibratory feeder and is supposed to be located above the vibratory feeder support plate. The cap vibratory feeder sits upon a feeder support plate. Un-capped sample containers pass underneath this support plate prior to being re-capped for storage. The Recapper Module is supplied by Thermo Fisher Scientific.
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code JJE·March 17, 2016
GYN-Laparoscopy Tray AMS1196(A convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016
Total Hip Pack, Kit number PSS2956 convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016
Wilson Implantation System Product Usage: Indicated to aid in tissue retraction during a surgical procedure.
FDA Recall
Terminated
·Applied Medical Technology Inc·Product code GAD·February 17, 2016
ENT Pack, Kit number AMS2727, AMS3237(A, and AMS4214. convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016
Ortho Kit, Kit number PSS1039(A and PSS1039(B convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016
TLC Self Retaining Retractor System Contents 1-RETRACTOR FRAME 6-ELASTIC STAYS STERILE EO Rx ONLY Product Usage: Indicated to aid in tissue retraction during a surgical procedure.
FDA Recall
Terminated
·Applied Medical Technology Inc·Product code GAD·February 17, 2016
TLC Self-Retaining Retractor Frames SINGLE USE ONLY Rx ONLY (USA) STERILE EO Do Not Resterilize. Product Usage: Indicated to aid in tissue retraction during a surgical procedure.
FDA Recall
Terminated
·Applied Medical Technology Inc·Product code GAD·February 17, 2016
Total Joint Pack, Kit number 006358-5 and 006358-6 convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016
Wilson Penile Implantation System Retractor Frame, Retractor Stays & Penile Elevation Strap, SINGLE USE ONLY Rx ONLY (USA) STERILE EO Do Not Resterilize Product Usage: Indicated to aid in tissue retraction during a surgical procedure.
FDA Recall
Terminated
·Applied Medical Technology Inc·Product code GAD·February 17, 2016
Facial Tray, Kit number PSS1558(A convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016
Bayview Breast Pack, Kit part numbers 009080-1 and 009080-2 convenience custom kits used for general surgery in hospital operating room
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016