137 results
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33ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Sapi Med sterile disposable colorectal anoscopes and proctoscopes. REF/Product Description: A.4083/THE BEAK - Surgical proctoscope. Disposable & sterile. Transparent. Self light; A.4519/MPR Short - Multi Purpose Rectoscope. 190mm long. Sterile & Disposable; A.4086/EPOFLIER - Surgical kit made of a 34,3mm wide anoscope and an opened retractor named GULL. Disposable & sterile; A.4084/THE BEAK Diagnostic- Disposable proctoscope. Transparent. Sterile & Self lighting; A.4522/ MPR - Multi Purpose Rectoscope. 220mm long. Sterile & Disposable
FDA Recall
Terminated
·Adler MicroMed, Inc.·Product code KDM·April 23, 2021
Sapi Med sterile disposable colorectal anoscopes and proctoscopes. REF/Product Description: A.4083/THE BEAK - Surgical proctoscope. Disposable & sterile. Transparent. Self light; A.4519/MPR Short - Multi Purpose Rectoscope. 190mm long. Sterile & Disposable; A.4086/EPOFLIER - Surgical kit made of a 34,3mm wide anoscope and an opened retractor named GULL. Disposable & sterile; A.4084/THE BEAK Diagnostic- Disposable proctoscope. Transparent. Sterile & Self lighting; A.4522/ MPR - Multi Purpose Rectoscope. 220mm long. Sterile & Disposable
FDA Enforcement
Class II
·Terminated·Adler MicroMed, Inc.·June 30, 2021
COACH¿ Self-Adhering Sports Wrap (size: 2in)
FDA Enforcement
Class II
·Terminated·Johnson & Johnson Consumer, Inc.·April 4, 2018
COACH¿ Self-Adhering Sports Wrap (size: 3in)
FDA Enforcement
Class II
·Terminated·Johnson & Johnson Consumer, Inc.·April 4, 2018
MAMMOGRAPHY
FDA Enforcement
Class II
·Terminated·Avid Medical, Inc.·August 24, 2016
PEDIATRIC KIDNEY BIOPSY TRAY
FDA Enforcement
Class II
·Terminated·Avid Medical, Inc.·August 24, 2016
Convenience Kits, MOHS "OPENING" PROCEDURE TRAY
FDA Enforcement
Class II
·Terminated·Avid Medical, Inc.·August 24, 2016
Convenience Kits, MOHS "OPENING" PROCEDURE TRAY
FDA Enforcement
Class II
·Terminated·Avid Medical, Inc.·August 24, 2016
Burn Relief¿, MODEL #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200, CATALOG #(s): 06BK1221, 06BK1232, 06BK1201, 06BK1200 --- DRESSING,WOUND,HYDROGEL W/OUT DRUG AND/OR BIOLOGIC. --- Burn Relief¿ products are self-cooling, non-adhering and are intended to be used on 1st and 2nd degree burns.
FDA Enforcement
Class II
·Terminated·O-Two Medical Technologies, Inc.·July 19, 2017
Johnson & Johnson BAND-AID¿ Brand First Aid Products SECURE-FLEX¿ Wrap (size: 3in)
FDA Enforcement
Class II
·Terminated·Johnson & Johnson Consumer, Inc.·April 4, 2018
Johnson & Johnson BAND-AID¿ Brand First Aid Products HURT-FREE¿ Wrap (size: 2in)
FDA Enforcement
Class II
·Terminated·Johnson & Johnson Consumer, Inc.·April 4, 2018
ST¿CKERT HeaterCooler System 3T; Item Number 160281, HeaterCooler 3T, 240V/60Hz; Item Number 160282, HeaterCooler 3T, 208V/60Hz; Item Number 160285, HeaterCooler 3T, 120V/ 60Hz The Heater Cooler 3T is used with a St¿ckert S3 heart lung machine and / or any other heart lung machine featuring a separate temperature control for extracorporeal perfusion of durations up to 6 hours
FDA Enforcement
Class II
·Terminated·Sorin Group USA, Inc.·December 7, 2016
Johnson & Johnson BAND-AID¿ Brand First Aid Products HURT-FREE¿ Wrap (size: 1in)
FDA Enforcement
Class II
·Terminated·Johnson & Johnson Consumer, Inc.·April 4, 2018
Johnson & Johnson BAND-AID¿ Brand First Aid Products SECURE-FLEX¿ Wrap (size: 2in)
FDA Enforcement
Class II
·Terminated·Johnson & Johnson Consumer, Inc.·April 4, 2018
MAMMOGRAPHY
FDA Recall
Terminated
·Avid Medical, Inc.·Product code LRO·October 5, 2015
Convenience Kits, MOHS "OPENING" PROCEDURE TRAY
FDA Recall
Terminated
·Avid Medical, Inc.·Product code LRO·October 5, 2015
Convenience Kits, MOHS "OPENING" PROCEDURE TRAY
FDA Recall
Terminated
·Avid Medical, Inc.·Product code LRO·October 5, 2015
PEDIATRIC KIDNEY BIOPSY TRAY
FDA Recall
Terminated
·Avid Medical, Inc.·Product code LRO·October 5, 2015
Sterile packaged wound dressing with white and green inner pouch and outer carton labels, labeled in part:''***V.A.C.*** ABDOMINAL DRESSING WITH NON ADHERENT LAYER***Re-Order No. M6275080/5***Manufactured for Corporate Headquarters: KCI USA, Inc., 8023 Vantage Dr., San Antonio, TX 78230 USA***''.
FDA Recall
Terminated
·Kinetic Concepts, Inc·Product code FTL·March 17, 2006
STCKERT HeaterCooler System 3T; Item Number 160281, HeaterCooler 3T, 240V/60Hz; Item Number 160282, HeaterCooler 3T, 208V/60Hz; Item Number 160285, HeaterCooler 3T, 120V/ 60Hz The Heater Cooler 3T is used with a Stckert S3 heart lung machine and / or any other heart lung machine featuring a separate temperature control for extracorporeal perfusion of durations up to 6 hours
FDA Recall
Terminated
·Sorin Group USA, Inc.·Product code DWC·August 1, 2014