26 results
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10ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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INFX-8000V Fluoroscopic X-Ray Systems; INFINIX CF-I/BP PLUS CARDIAC SYSTEM
FDA Recall
Terminated
·Toshiba American Medical Systems Inc·Product code OWB·December 29, 2017
INFX-8000V Fluoroscopic X-Ray Systems; INFINIX CF-I/BP PLUS CARDIAC SYSTEM
FDA Enforcement
Class II
·Terminated·Toshiba American Medical Systems Inc·March 14, 2018
INFX-8000V Interventional Angiography System. CAT-880B catheterization table. Cardiac and Vascular intervention with fluoroscopic and fluorographic images. For the USA and Canada the system is registered as lnfinix CF-i or lnfinix VF-i, for national regulations. INFX-8000V series includes a floor mounted multi-axis positioner.
FDA Enforcement
Class II
·Terminated·Toshiba American Medical Systems Inc·April 15, 2015
Sterile, Drape, Headset, Lower, Part Number 888944-01.
FDA Recall
Terminated
·GE Medical Systems, LLC·Product code MMP·August 15, 2008
Sterile, Drape, Headset, Upper, Part Number 888945-01.
FDA Recall
Terminated
·GE Medical Systems, LLC·Product code MMP·August 15, 2008
INFX-8000V Interventional Angiography System. CAT-880B catheterization table. Cardiac and Vascular intervention with fluoroscopic and fluorographic images. For the USA and Canada the system is registered as lnfinix CF-i or lnfinix VF-i, for national regulations. INFX-8000V series includes a floor mounted multi-axis positioner.
FDA Recall
Terminated
·Toshiba American Medical Systems Inc·Product code OWB·March 11, 2015
Disposable Pack, Headset Part Number 888946-01(kit includes Part Number 888944-01, Sterile, Drape, Headset, Lower and Part Number 888945-01, Sterile, Drape, Headset, Upper).
FDA Recall
Terminated
·GE Medical Systems, LLC·Product code MMP·August 15, 2008
GE Medical Systems, OEC, Vascular Drape, 00-902776-01, Sterile. 150" long x 87" wide. Distributed by GE OEC Medical Systems, Salt Lake City, UT 84116 USA.
FDA Recall
Terminated
·GE Medical Systems, LLC·Product code MMP·August 15, 2008
TandemHeart Transseptal Cannulas-EF set (THTC-EF) - Dilator assembly The TandemHeart Transseptal Cannula Set-EF is intended for transseptal catheterization of the left atrium via the femoral vein for the purpose of providing a means for temporary (six hours or less) left ventricular bypass when connected to the TandemHeart extracorporeal blood pump which returns blood to the patient via the femoral artery or other appropriate site.
FDA Recall
Terminated
·Cardiac Assist, Inc·Product code DWF·December 2, 2010
FDI FORT DEFIANCE INDUSTRIES P2131 AUTOMATED FIELD STEAM STERILIZER, NSN: 6530-01-641-4641 Product Usage: The Fort Defiance Industries Automated Field Steam Sterilizer Model P2131 is designed for sterilization of porous and non-porous, heat- and moisture-stable materials (e.g., surgical instruments and textiles) used in healthcare facilities. The P2131 sterilizer is a transportable device designed for use in a variety of austere environments.
FDA Enforcement
Class II
·Terminated·Fort Defiance Industries, LLC·July 18, 2018
Nova StatStrip Xpress Glu-Test Strips (Glucose test strips) Catalog # 51493 (UK Only)
FDA Recall
Terminated
·Nova Biomedical Corporation·Product code CGA·February 25, 2013
Nova StatStrip Xpress Glu-Test Strips (Glucose test strips) Catalog # 42214
FDA Recall
Terminated
·Nova Biomedical Corporation·Product code CGA·February 25, 2013
Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN DESCRIPTION M001271540 FLEXIMA BILIARY FIRM 8F/35CM M001271550 FLEXIMA BILIARY FIRM 10F/35CM M001271560 FLEXIMA BILIARY REG 8F/35CM M001271570 FLEXIMA BILIARY REG 10F/35CM M001271580 FLEXIMA BILIARY REG 12F/35CM M001271590 FLEXIMA BILIARY REG 14F/35CM M001271600 FLEXIMA BILIARY SOFT 10F/35CM M001271610 FLEXIMA BILIARY SOFT 12F/35CM M001271620 FLEXIMA BILIARY SOFT 14F/35CM M001281560 FLEXIMA BILIARY 8/35 TT M001281570 FLEXIMA BILIARY 10/35 TT M001281580 FLEXIMA BILIARY 12/35 TT M001281590 FLEXIMA BILIARY 14/35 TT M001271630 FLEXIMA BIL 8F/35CM FIRM KIT M001271640 FLEXIMA BIL 10F/35CM FIRM KIT M001271650 FLEXIMA BIL 8F/35CM REG KIT M001271660 FLEXIMA BIL 10F/35CM REG KIT Single Use Only, Sterilized with Ethylene Oxide Gas, Boston Scintific Corporation, One Boscton Scintific Place, Natick, MA 01760-1537, Made in USA 780 Brookside Drive, Spencer, IN 47460 1080. Designed for percutaneous drainage of abscess fluid, the Biliary system and the urinary tract.
FDA Recall
Terminated
·Boston Scientific Corporation·Product code FFA·March 18, 2009
Boston Scientific Profile Single-Use Pediatric Snare 13mm UPN Outer Box: M00562551 Inner Pouch: M00562550 The single-use Profile Polypectomy Snare consists of a flexible wire cable loop which can be extended and retracted from the snare's flexible outer sheath using a three-ring handle. When passed through an endoscope and activated, the snare delivers a monopolar electrical current to cut and cauterize tissue with the loop
FDA Recall
Terminated
·Boston Scientific Corporation·Product code FDI·May 16, 2012
Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN# DESCRIPTION 435428-01 M001273030 FLEXIMA VSCL REG 12FR/35CM M001273040 FLEXIMA VSCL REG 14FR/35CM M001273090 FLEXIMA VSDC REG LOOP 12/35KIT M001273100 FLEXIMA VSDC REG LOOP 14/35KIT M001273150 FLEXIMA VSCL FIRM 12FR/35CM M001273160 FLEXIMA VSCL FIRM 14FR/35CM M001273210 FLEXIMA VSDC FIRM LOOP 12/35 M001273220 FLEXIMA VSDC FIRM LOOP 14/35 Single Use Only, Sterilized with Ethylene Oxide Gas, Boston Scintific Corporation, One Boscton Scintific Place, Natick, MA 01760-1537, Made in USA 780 Brookside Drive, Spencer, IN 47460 1080. Designed for percutaneous drainage of abscess fluid, the Biliary system and the urinary tract.
FDA Recall
Terminated
·Boston Scientific Corporation·Product code FFA·March 18, 2009
Olympus SD Snares, Reusable Electrosurgical Snares. Models: SD-9L/U-1, SD-11L/U-1, SD-12L/U-1, SD-13L/U-1, SD-13L/U-1, & SD-16L/U-1. Snare tube model numbers: MAJ-13 and MAJ-15. To be used with Olympus endoscopes to electrosurgically resect tissue within the digestive tract.
FDA Recall
Terminated
·Olympus America Inc.·Product code FDI·May 3, 2010
Covidien Clearify Visualization System Item Code: 21-345 Intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope as well as clean the scope lens
FDA Recall
Terminated
·Medtronic·Product code FEI·October 4, 2016
Best Practices kits containing certain production lots of Clearify Visualization System Item Code: 21-345 Intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope as well as clean the scope lens
FDA Recall
Terminated
·Medtronic·Product code FEI·October 4, 2016
Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN DESCRIPTION M001271240 FLEXIMA APDL FIRM 10F/25CM M001271310 FLEXIMA APDL FIRM 6.3F/25CM M001271320 FLEXIMA APDL FIRM 8F/25CM M001271330 FLEXIMA APDL REG 6.3F/25CM M001271340 FLEXIMA APDL REG 8F/25CM M001271350 FLEXIMA APDL REG 10F/25CM M001271380 FLEXIMA APDL REG 12F/25CM M001271390 FLEXIMA APDL REG 14F/25CM M001271460 FLEXIMA QUICKSTICK LL 8FR M001271470 FLEXIMA QUICKSTICK LL 10FR M001275060 APDTL/7.3FR FLEXIMA SINGLE TT M001275080 APDLTL/7.3FR FLEXIMA SINGLE TT M001281340 FLEXIMA APDL 8/25 TT M001281350 FLEXIMA APDL 10/25 TT M001281380 FLEXIMA APDL 12/25 TT M001281390 FLEXIMA APDL 14/25 TT M001271960 FLEXIMA APDL 8FR REG KIT M001271970 FLEXIMA APDL 10FR REG KIT M001271980 FLEXIMA APDL 8FR FIRM KIT M001271990 FLEXIMA APDL 10FR FIRM KIT M001275070 APDTL/7.3FR FLEXIMA KIT TT M001275010 APDLTL/7.3 FLEXIMA FIRM SINGLE M001275090 APDLTL/7.3FR FLEXIMA KIT TT M001275030 FLEXIMA APDLTL/7/30 STAND KIT M001275050 FLEXIMA APDLTL/7/30 DELUXE KIT Single Use Only, Sterilized with Ethylene Oxide Gas, Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 01760-1537, Made in USA 780 Brookside Drive, Spencer, IN 47460 1080. Designed for percutaneous drainage of abscess fluid, the Biliary system and the urinary tract.
FDA Recall
Terminated
·Boston Scientific Corporation·Product code FFA·March 18, 2009
Boston Scientific Profile Single-Use Pediatric Snare 11mm UPN Outer Box M00562531 Inner Pouch: M00562530 , The single-use Profile Polypectomy Snare consists of a flexible wire cable loop which can be extended and retracted from the snare's flexible outer sheath using a three-ring handle. When passed through an endoscope and activated, the snare delivers a monopolar electrical current to cut and cauterize tissue with the loop
FDA Recall
Terminated
·Boston Scientific Corporation·Product code FDI·May 16, 2012