163 results
·
11ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
×
CONCEPT GRAFIX TENDON STRIPPER. REF TS8850. 7.0MM, QTY 1. Rx Only, Non-Sterile, Made In USA.
FDA Recall
Terminated
·Linvatec Corp. dba ConMed Linvatec·Product code FZW·January 29, 2010
Zimmer Dermacarriers II skin graft carriers, 9 to 1 dermacarrier, Rx, latex free, sterile, Qty 1, Zimmer, Dover, Ohio; REF 00-2195-015-00. Single use device for use during skin grafting procedures.
FDA Recall
Terminated
·Zimmer Inc.·Product code FZW·April 3, 2008
Zimmer Dermacarriers skin graft carriers, S.G. Carrier 8IN length, Rx, latex free, sterile, Zimmer, Dover, Ohio; REF 00-7708-000-10. Single use device for use during skin grafting procedures.
FDA Recall
Terminated
·Zimmer Inc.·Product code FZW·April 3, 2008
Zimmer Dermacarriers Skin Graft Carriers, S.G. Carrier 16IN length, Rx, latex free, sterile, Zimmer, Dover, Ohio; REF 00-7716-000-10. Single use device for use during skin grafting procedures.
FDA Recall
Terminated
·Zimmer Inc.·Product code FZW·April 3, 2008
Zimmer Dermacarriers II skin graft carriers, 3 to 1 dermacarrier, Rx, latex free, sterile, Qty 1, Zimmer, Dover, Ohio; REF 00-2195-013-00. Single use device for use during skin grafting procedures.
FDA Recall
Terminated
·Zimmer Inc.·Product code FZW·April 3, 2008
Zimmer Dermacarriers II skin graft carriers, 1.5 to 1 dermacarrier, Rx, latex free, sterile, Zimmer, Dover, Ohio; REF 00-2195-012-00. Single use device for use during skin grafting procedures.
FDA Recall
Terminated
·Zimmer Inc.·Product code FZW·April 3, 2008
Zimmer Dermacarriers II skin graft carriers, 6 to 1 dermacarrier, Rx, latex free, sterile, Qty 1, Zimmer, Dover, Ohio; REF 00-2195-014-00. Single use device for use during skin grafting procedures.
FDA Recall
Terminated
·Zimmer Inc.·Product code FZW·April 3, 2008
A2613 SPINAL(FL)W/DRUGS
FDA Recall
Terminated
·Smiths Medical ASD, Inc.·Product code CAZ·July 2, 2004
A2654-24 SPINAL (FL) W/DRUGS
FDA Recall
Terminated
·Smiths Medical ASD, Inc.·Product code CAZ·July 2, 2004
NxStage Express Fluid Warmer (FW-300, FW-300-A, FW-300-WW, FW-301, FW-301-A) Product Usage: The NxStage Express Fluid Warmer is an accessory to the NxStage System One used to warm therapy fluids prior to administration.
FDA Enforcement
Class II
·Terminated·NxStage Medical, Inc.·August 22, 2018
Radionuclide Radiation Therapy System Product The product is a teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·May 4, 2016
Leksell Gamma Knife Perfexion, Article #715000. Teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters.
FDA Recall
Terminated
·Elekta, Inc.·Product code IWB·July 2, 2007
Radionuclide Radiation Therapy System Product The product is a teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters.
FDA Recall
Terminated
·Elekta, Inc.·Product code IWB·April 19, 2016
Leksell Gamma Knife Perfexion, Product Number: 715000. Radionuclide radiation therapy system. Elekta, Inc. Norcross, GA. Intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters.
FDA Recall
Terminated
·Elekta, Inc.·Product code IWB·November 6, 2009
Leksell Gamma Knife Perfexion, Radionuclide radiation therapy system. Article Number 715000, Elekta, Inc. Norcross, GA 30092. Teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sized os a few millimeters to several centimeters.
FDA Recall
Terminated
·Elekta, Inc.·Product code IWB·November 9, 2008
Labeling is as follows: Product labeling: ''***Argon Medical Devices***RE-ORDER NO./REF 193248***12cc Control Syringe***ST/FR/TR/FM w/ Reservoir***This device is designed for the administraion and removal of fluids.***DISPOSABLE*SINGLE USE*DO NOT RESTERILIZE***STERILE EO***STERILIZED BY EtO***Argon Medical Devices, Inc. 1445 Flat Creek Road Athens, TX 75751 800-927-4669***'' Carton Labeling: ''***Argon Medical Devices***12cc Control Syringe***ST/FR/TR/FM W/ Reservoir***This device is designed for the administraion and removal of fluids.***REF/REORDER NO. 193248***Quantity: 25 ea.***STERILE EO***STERILIZED BY EtO***DISPOSABLE*SINGLE USE*DO NOT RESTERILIZE***Argon Medical Devices, Inc. 1445 Flat Creek Road Athens, TX 75751 800-927-4669***''
FDA Recall
Terminated
·Argon Medical Devices, Inc·Product code IZI·June 27, 2005
Product consists of a syringe used to inject fluids during an angiographic procedure for fluoroscopic imaging. Labeling is as follows: Product Label ''***Argon Medical Device***10cc Control Syringe FR/TR/FM w/ Reservoir SINGLE USE ONLY***REF/REORDER NO. 093205***This device is designed for the administration and removal of fluids***Quantity: 25ea***NON-STERILE*FURTHER PROCESSING REQUIRED***Eto (ethylene oxide) Sterilization Recommended***1445 FLAT CREEK ROAD - ATHENS, TX 75751***800-927-4669***'' Carton Label ''***Argon Medical Device***10cc Control Syringe FR/TR/FM w/ Reservoir SINGLE USE ONLY***REF/REORDER NO. 093205***This device is designed for the administration and removal of fluids***Quantity: 250ea***NON-STERILE*FURTHER PROCESSING REQUIRED***Eto (ethylene oxide) Sterilization Recommended***1445 FLAT CREEK ROAD - ATHENS, TX 75751***800-927-4669***''
FDA Recall
Terminated
·Argon Medical Devices, Inc·Product code IZI·June 27, 2005
Product consists of a syringe used to inject fluids during an angiographic procedure for fluoroscopic imaging. Labeling is as follows: Product Label ''***Argon Medical Device***REORDER NO./REF 193205***10cc Control Syringe FR/TR/FM w/ Reservoir***This device is designed for the administration and removal of fluids***DISPOSABLE***SINGLE USE ONLY***DO NOT RESTERILIZE***STERILE***EO***STERILIZED BY EtO***Sterile Unless Opened or Damaged***Argon Medical Devices, Inc. 1445 FLAT CREEK ROAD - ATHENS, TX 75751***800-927-4669***'' Carton Label ''***Argon Medical Device***10cc Control Syringe FR/TR/FM w/ Reservoir***This device is designed for the administration and removal of fluids***REF/REORDER NO. 193205***Quantity: 25ea***STERILE***EO***STERILIZED BY EtO***DISPOSABLE***SINGLE USE ONLY***DO NOT RESTERILIZE***Sterile Unless Opened or Damaged***Argon Medical Devices, Inc. 1445 FLAT CREEK ROAD - ATHENS, TX 75751***800-927-4669***''
FDA Recall
Terminated
·Argon Medical Devices, Inc·Product code IZI·June 27, 2005
Mach 1 6F Kimny Guide Catheter. Catalog No. 34356-583. Sterilized with ethylene oxide gas. Nonpyrogenic. Intended for one procedure use only. Manufacturer: Boston Scientific Scimed, Inc., One Scimed Place, Maple Grove, MN USA 55311.
FDA Recall
Terminated
·Boston Scientific Scimed·Product code DQY·May 24, 2004
Mach 1 6F JR 3.5 Guide Catheter. Catalog No. 34356-685. Sterilized with ethylene oxide gas. Nonpyrogenic. Intended for one procedure use only. Manufacture: Boston Scientific Scimed, Inc., One Scimed Place, Maple Grove, MN USA 55311
FDA Recall
Terminated
·Boston Scientific Scimed·Product code DQY·May 24, 2004