250 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Completed
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ImplantDirect InterActive Precision IO Scan Adapter, Part #6530-09PT, Platform: 3.0mm, Non-Sterile, Rx. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
FDA Enforcement
Class II
·Completed·Implant Direct Sybron Manufacturing, LLC·January 15, 2020
ImplantDirect InterActive Precision IO Scan Adapter, Part #6534-09PT, Platform: 3.4mm, Non-Sterile, Rx. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
FDA Enforcement
Class II
·Completed·Implant Direct Sybron Manufacturing, LLC·January 15, 2020
ImplantDirect InterActive Precision IO Scan Adapter, Part #6534-09PT, Platform: 3.4mm, Non-Sterile, Rx. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
FDA Recall
Completed
·Implant Direct Sybron Manufacturing, LLC·Product code NDP·November 28, 2018
ImplantDirect InterActive Precision IO Scan Adapter, Part #6530-09PT, Platform: 3.0mm, Non-Sterile, Rx. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
FDA Recall
Completed
·Implant Direct Sybron Manufacturing, LLC·Product code NDP·November 28, 2018
Hillrom Temperature Management Controller, MP, Model # 2083516; used in conjunction with Warming Blankets and Mattresses.
FDA Recall
Completed
·Augustine Temperature Management, LLC·Product code DWJ·March 14, 2022
Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) WC77V; 2) WC77V-DEMO; 3) WC77V-R; used in conjunction with Warming Blankets and Mattresses, veterinary use.
FDA Recall
Completed
·Augustine Temperature Management, LLC·Product code DWJ·March 14, 2022
Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # WC71, 2) Model # WC71R (refurbished); used in conjunction with Warming Blankets and Mattresses.
FDA Recall
Completed
·Augustine Temperature Management, LLC·Product code DWJ·March 14, 2022
Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # WC77, 2) Model # WC77D (Demo), 3) Model # WC77R (Refurbished); used in conjunction with Warming Blankets and Mattresses.
FDA Recall
Completed
·Augustine Temperature Management, LLC·Product code DWJ·March 14, 2022
Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) WC71V; 2) WC71V-DEMO; 3) WC71V-R; used in conjunction with Warming Blankets and Mattresses, veterinary use.
FDA Recall
Completed
·Augustine Temperature Management, LLC·Product code DWJ·March 14, 2022
ProPlan CMF Anatomical Model, Maxilla-Cranium, Clear Identification number SD900.208
FDA Recall
Completed
·Materialise USA LLC·Product code HWT·July 13, 2022
Brand Name: UNclog Eye Mask Product Name: UNclog Eye Mask Model/Catalog Number: AG23JW24 Serial # ag22 Product Description: Heated eye mask Component: Heating unit, wire
FDA Recall
Completed
·EYE COMFORT CARE LLC·Product code IRT·February 8, 2024
SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO
FDA Recall
Completed
·SynCardia Systems LLC·Product code LOZ·August 1, 2023
Liberty Select Cycler Software Version 2.9.0 Model Number 180343 and RTLR180343
FDA Recall
Completed
·Fresenius Medical Care Holdings, Inc.·Product code FKX·September 12, 2020
Covidien TA Auto Suture Vascular Stapler with DST Series Technology 30mm-V 3. Intended for abdominal, gynecological, pediatric and thoracic surgical procedures for resection or transection of tissue. Item Number: TA30V3S
FDA Recall
Completed
·Covidien Llc·Product code GDW·November 23, 2020
Covidien TA Auto Suture Vascular Loading Unit with DST Series Technology 30 mm- V3. Intended for abdominal, gynecological, pediatric and thoracic surgical procedures for resection or transection of tissue. Item Number: TA30V3L
FDA Recall
Completed
·Covidien Llc·Product code GDW·November 23, 2020
4.0mm x 10mm Cannulated Screw, Short Thread; Part number 3005-40010
FDA Recall
Completed
·Acumed LLC·Product code HWC·March 9, 2022
4.0mm x 12mm Cannulated Screw, Short Thread; Part number 3005-40012
FDA Recall
Completed
·Acumed LLC·Product code HWC·March 9, 2022
Pediatric Pack - contains Devon Light Glove Used during surgery
FDA Recall
Completed
·Stradis Healthcare, LLC.·Product code LRO·April 20, 2015
Suction Pack - contains Devon Light Glove Used during surgery
FDA Recall
Completed
·Stradis Healthcare, LLC.·Product code LRO·April 20, 2015
Upper Extremity Pack - contains Devon Light Glove Used during surgery
FDA Recall
Completed
·Stradis Healthcare, LLC.·Product code LRO·April 20, 2015